Note to File: Recent Episodes
Brad Hightower
Note to File is a podcast for clinical research sites - interviews, best practices, and candid commentary from Brad Hightower, founder of Hightower Clinical and clinical research professional.
In this electrifying episode, legal experts Darshan Kulkarni and Edye Edens dive deep into the complex world of clinical research. From HIPAA compliance and corporate practice of medicine to the hidden risks facing research sites, they break down critical legal insights with their signature wit and candor. Prepare for an eye-opening conversation that goes beyond the typical industry talk.
In this episode of Note to File, we dive into the recent merger between Circuit and Lightship, explore the behind-the-scenes challenges of clinical research site training, and discuss the ongoing consolidation in the clinical trial industry. Join us for candid insights, industry gossip, and a no-holds-barred conversation about the realities of clinical research.
We discuss National Clinical Trials Day, Mexico's emerging clinical research landscape, and Javara's recent Series C funding. We dive into the challenges of oncology trials, explore the role of venture capital in healthcare, and share some industry gossip about Signant Health's recent job posting for a Director of Reputation and Crisis Communications.
Somehow Note to File has existed for 5 years now....
In this episode we sit down with healthcare veteran Matthew Holt, founder of The Health Care Blog and Health 2.0. Matthew shares his fascinating journey from Stanford grad student to healthcare technology commentator, offering candid insights into digital health, clinical trials, and the challenges of healthcare innovation. From discussing the potential of GLP-1 drugs to exploring the future of longevity research, this conversation provides a witty and insightful look at the evolving landscape of healthcare technology and research.
In this episode of Note to File, we dive deep into the world of clinical research, exploring the challenges of resident physician training, the impact of private equity on clinical trial management systems, and the often-unspoken ethical dilemmas in the field.
Join us as we unpack difficult sponsor behaviors, share hilarious research confessions, and offer candid insights into the clinical research landscape. From PE investments to research sins, this episode is packed with humor, honesty, and hard-hitting discussions that will keep you entertained and informed.
Special Pope election edition.
In this episode, Rohit Nambisan from Lokavant and Jonathan Crowther from Pfizer discuss their innovative approach to clinical trial forecasting. They explore how advanced data analytics and AI can help predict and improve trial operational success, from site selection to protocol design. The conversation delves into reducing uncertainty, enhancing communication between sponsors and sites, and leveraging technology to make clinical research more efficient and patient-focused.
In this episode, Meri Beckwith from Lindus Health discusses his journey from venture capital to clinical research, sharing insights on the inefficiencies of traditional CROs. He explains how Lindus is taking a different approach by aligning incentives, focusing on patient experience, and developing innovative trial models. The conversation explores the challenges in clinical trials, from data collection to site management, offering a fresh perspective on how the industry might evolve.
In this episode of Sticky Notes, Brad & Denali dive into the latest trends in clinical research, exploring how younger adults are getting medical advice from social media, the potential impact of pharmaceutical tariffs on R&D, and the evolving landscape of decentralized clinical trials.
We discuss the challenges and opportunities of involving healthcare providers in clinical research, and touch on recent layoffs in the CRO industry.
Join us for an insightful and candid conversation about the current state of clinical trials and occasional debates about cookies.
We sit down with Bree Burks from Veeva to discuss the company's latest innovations in clinical research technology. We dive deep into Veeva's upcoming CTMS (Clinical Trial Management System), their strategy for connecting sponsors and sites, and the importance of creating more streamlined, user-friendly technology for clinical research sites. Bree shares insights from her nursing background and Veeva's mission to simplify technology for sites, making clinical trials more efficient and patient-focused.
In this episode, Brad and Denali dive into recent industry developments, including Bay Pine's $1.5 billion acquisition of CenExel clinical research site network, the FDA's potential shift to AI-based animal testing alternatives, growing challenges with clinical trial recruitment and public trust, emerging pharmaceutical import tariffs, and the ongoing wave of layoffs in the life sciences sector. The discussion offers candid insights into the evolving landscape of clinical research, technology, and market dynamics.
In this episode Jim Kremidas, Executive Director of the Association of Multi-Site Research Corporations (AMRC), discusses the evolving landscape of clinical research sites. We explore how multi-site research corporations are working to improve operational efficiency, quality standards, and patient experiences in clinical trials. Kremidas shares insights from his extensive background in pharmaceutical research highlighting the potential benefits of site network consolidation and standardization.
In this episode, we sit down with Jamie Massengill from SSM Health to unpack the complex world of clinical research in community healthcare. We dive deep into the challenges of launching successful research programs, exploring innovative partnership models, physician engagement strategies, and how community hospitals can transform clinical trials. Learn how breaking traditional barriers can create meaningful research opportunities that benefit patients, physicians, and healthcare systems alike.
Originally recorded in April 2022.
In this episode we talk with Chris Venezia, CEO of ProofPilot, about the often-overlooked operational challenges in clinical trials. Chris shares his unexpected journey into clinical research and reveals how ProofPilot is transforming the industry by simplifying communication, document sharing, and patient engagement. From addressing fundamental communication gaps to exploring innovative solutions, this conversation offers a refreshing look at making clinical trials more efficient and user-friendly.
We talk to Science 37 CEO Tyler Van Horn and discuss the past, present and future of the company - everything you wanted to know about Science 37 but were afraid to ask.
This episode is dedicated to feedback about the recent Save Our Sites (SOS) conference in Oklahoma City. The founders, Judy Galindo, Ashley Margot, Chris Sauber, Monica Cultiva and Dan Sfera join as we take live feedback from the livestream audience.
A short recap of recent news, events, social media posts, gossip, announcements, and anything else in the clinical research space.
In this episode Paul Ivsin joins to talk Science 37 v Science 38, PEs buyout of Walgreens and CRA/CRC relationships.
Today we discuss vendor relationships , representation & its impact on business, diagnosis & after care - the main unmet need within pharma - and embroidery throwing.
In this episode Dan Sfera joins us to cover the somewhat puzzling creation of the Association for Multisite Corporations (AMRC), a big time data breach from DM Clinical Research, and why everything in clinical research is an emergency.
In this episode we discuss the challenges and perceptions of central recruitment campaigns, including resistance from sites, the need for a thoughtful, patient-centered approaches rather than a boiler room approach and Paul helps to dispell a few clinical trial myths.
Kerri Weingard is a founding partner and global chief operating officer at Verified Clinical Trials (VCT). VCT is the largest global research subject database to reduce dual enrollment and prevent protocol violations. Ms. Weingard is also the CEO and founder of Study Scavenger and Clinical Hero. Both companies are dedicated to clinical trial recruitment and education. Ms. Weingard, who is a nurse practitioner, holds a master’s degree in science from Stony Brook University. She, before creating VCT and Study Scavenger, has conducted over 500 clinical trials as a research administrator and sub-investigator. She has more than two decades of experience in the field and is a member of a number of professional organizations, including the American Society for Clinical Pharmacology and Therapeutics, the Drug Information Association and the Association of Clinical Research Professionals.
Ignacio Handal is the CEO at Clinicom Healthcare. Ignacio has completed a multitude of FDA phase I, II, & III studies in pharmaceuticals, and devices over two decades. In 2022 Ignacio was honored with one of the highest honors in Clinical Research, the Christine Pierre Clinical trials lifetime achievement award of which only 8 clinical researchers globally have ever been awarded.
Early in his career Ignacio, Co-Founded the 5th leading private CNS research site in the US called Harmonex Neuroscience research in 2003 that continues excelling to this day.
Ignacio and his team have used 100% of the profits of their research trials over the last twenty years to develop the world's first online mental health assessment software that can assess anyone remotely for 81 mental health conditions in one virtual adaptive ML assessment. Clinicom has helped patients all over the world find answers on their mental health journey. Clinicom has also helped accelerate enrollment and patient identification for precise inclusion and exclusion criteria in 70 phase II and III studies in the US. The Clinicom mission is to give every patient a voice and to bring equity and access to mental health. Clinicom currently serves patients on 6 continents.
This week we discuss how to improve site selection, the challenges of vendor selection, and how Clinicom was born from a site.
Ignacio Handal on LinkedIn: https://www.linkedin.com/in/iggyhandal/
Clinicom on the web: www.clinicom.com/overview
Learn more about our sponsor, Veeva Vault: http://sites.veeva.com
Learn more about our sponsor, Inato: https://go.inato.com/41YxjXY
Thomas Peterson has been in healthcare for approximately 17 years now. A vast majority of that experience is in clinical research. He has served in many capacities such as a Research Assistant, Study Coordinator, Senior Study Coordinator, Clinical Research Associate and now Senior Clinical Research Associate. He founded his own consulting company to assist anyone in the clinical research space that needs guidance. Thomas works within the oncology, neuro-oncology, rare disease, infectious disease spaces as well as pediatrics.
This week we discuss the shift from CRC to CRA, humanity in clinical trials, the downstream effects of “innovation” in the industry and so much more.
Thomas Peterson in LinkedIn: http://www.linkedin.com/in/thomas-peterson-6173a7228
Peterson Research: www.peterson-research.com
Learn more about our sponsor, Veeva Vault: http://sites.veeva.com
Learn more about our sponsor, Inato: https://go.inato.com/41YxjXY
Jason Palasota had always been passionate about improving the quality of clinical research services delivered to patients. He first got his feet wet working on the ground level as a site coordinator for Cetero Research, formerly known as Diabetes and Glandular Research. From there, he began to develop an even deeper respect for the industry and continued to pursue opportunities that would allow him to drive change. After working on the ground level, he was inspired to make an impact and improve the quality of clinical research services delivered to patients. Determined to bring about positive change, Jason worked his way up from proposal development and inside sales roles to external business development positions at Worldwide Clinical Trials, ResearchPoint Global, and IQVIA (formally Quintiles). As Jason gained more experience in this field, he became increasingly aware of significant relationship and communication gaps that existed within the industry. He was determined to bridge these gaps by forming strong partnerships between exceptional clinical research sites and innovative sponsors/CROs. His goal was simple: make a positive difference in people’s lives through top-tier healthcare solutions around the world. Clinitiative Health Research was born.
This week we discuss the various business development models for sites, why sites might want to consider partnering with a business development vendor, and the incredible significance of relationships in clinical research.
Clinitiative Health Research on Linkedin: https://www.linkedin.com/company/clinitiative/
Clinitiative Health Research on Twitter: https://twitter.com/ClinitiativeHR ,
Clinitiative Health Research on Facebook: https://www.facebook.com/ClinitiativeHealthResearch
Learn more about our sponsor, Inato: https://go.inato.com/41YxjXY
Trained as a neuroscientist, Rohit Nambisan is a product executive with experience leading product development organizations in pharma, medical devices, personalized medicine, health IT, healthcare data and analytics, and AI. Prior to co-founding and leading Lokavant, Rohit was most recently the Head of Digital Product at Roivant and the Head of Product at Prognos Health. Rohit holds an M.S in Management and Engineering from MIT, an M.A. in Neuroscience from Boston University, and a B.A in Cognitive Neuroscience from UC Berkeley.
In this episode we discuss fragmentation amongst study stakeholders, the importance of real time data that’s agnostic to source, and the impact of decentralized clinical trials and an increase in disparate data sources.
Rohit Nabisan on LinkedIn: https://www.linkedin.com/in/rohitnambisan/
Lokavant website: https://www.lokavant.com/
Learn more about our sponsor, Inato: https://go.inato.com/41YxjXY
Brittany Sloan is the Director of Black Research Matters, a safe space exclusively for Black people to learn more about research with the purposes of being becoming better-informed decision-makers thus strengthening the community by using knowledge as a tool to navigate the medical and healthcare systems.
This episode is the conclusion of a 3 part series on the Tuskegee Syphilis Experiments presented by Brittany.
Brittany Sloan on LinkedIn: https://www.linkedin.com/in/whitney-stewart-b9969326/
Learn more about our sponsor, Inato: https://go.inato.com/41YxjXY
Whitney Stewart is the director of clinical project management at Curebase. She has served the clinical research space for more than 10 years, and holds bachelors' degrees in Molecular and Cellular biology, and Italian Studies.
In this episode we discuss evidence standards for digital therapeutics and the recent Digital Therapeutics Alliance publication “Setting the Stage for a Fit-For-Purpose DTx Evidentiary Standard”.
Whitney on LinkedIn: https://www.linkedin.com/in/whitney-stewart-b9969326/
Digital Therapeutics Alliance and Curebase release publication setting the stage for a fit-for-purpose evidence standard for digital therapeutics (DTx): https://www.curebase.com/news/digital-therapeutics-alliance-and-curebase-release-publication-setting-the-stage-for-a-fit-for-purpose-evidence-standard-for-digital-therapeutics-dtx
Learn more about our sponsor, Inato: https://go.inato.com/41YxjXY
Amanda Santimaw is the Director of Clinical Research for the 9 locations of Arizona Arthritis & Rheumatology, plus 4 external physician locations. She is responsible for the oversight of over 180 current clinical trials, 17 Principal Investigators, 24 dedicated research staff working in rheumatology, gastroenterology, endocrinology, and internal medicine. She has 15 years of experience working in Phase I-IV clinical trials, observational studies, and retrospective data analysis. Amanda received both her Bachelors of Science and Masters of Science in Clinical Research Management from Arizona State University. When Amanda is not at work, she enjoys spending time with her husband, daughter and new baby, going hiking, camping, and traveling
Rebecca Martinez is the Operations Manager of Clinical Research and is Amanda’s co-pilot for all the locations. She has over 10 years’ experience in the clinical research field in rheumatology and gastroenterology. She is responsible for the successful study start-up, recruitment, and maintenance for all the ongoing trials. She too received her masters of science in clinical research management from ASU.
This week we discuss the challenges of managing site level documents, making the jump to electronic regulatory with Veeva, CTMS, eSource and so much more.
Wayne Walker is Senior Vice President, Product for Rave Platform Technology (including Rave EDC, Rave RTSM, Rave Imaging, Rave Coder, and Rave Safety Gateway) at Medidata. His responsibilities include the strategy, development, and delivery of these products across all Research & Development disciplines. Before joining Medidata, Wayne spent 12 years overseeing Product Management for clinical technology used by Data Management and Biometrics at PRA Health Sciences. This involved oversight of Platform as a Service, Software as a Service, on-premise deployed environments, and in-house developed solutions
This week we discuss the vendor/site relationships, why there is a proliferation of disparate systems, the potential of direct to EDC data entry and so much more.
Charles Fisher is the founder of Unlearn which is using AI to simulate potential health outcomes for individual patients.
Charles is a scientist with interests at the intersection of physics, machine learning, and computational biology. Previously, Charles worked as a machine learning engineer at Leap Motion and a computational biologist at Pfizer. He was a Philippe Meyer Fellow in theoretical physics at École Normale Supérieure in Paris, France, and a postdoctoral scientist in biophys.ics at Boston University. Charles holds a Ph.D. in biophysics from Harvard University and a B.S. in biophysics from the University of Michigan.
This week we discuss digital twins, the impact of AI on clinical trials, clinical trial data ownership and much more
Amy is a leader with experience in clinical trial program operations and regulatory compliance. As a results-driven professional, she has a proven ability to oversee program processes, project management, quality improvement, and timely execution of clinical trials. Knowledgeable in academic and large healthcare settings, as well as public health and private physician practices. Her areas of expertise focus on early phase human pharmaceutical clinical research in the specialties of pediatrics, oncology, neurology, cardiology, infectious disease, dermatology, and diabetes.
This week we discuss the increasing complexity of clinical trials operations, connecting SOPs to processes and the difference between QC and QA.
Dan Otap is a Principal Alliance & Partnerships Lead within Genentech’s Research and Early Development unit (gRED). Dan’s clinical trial operations and compliance background uniquely position him to provide attuned insight into relational site engagement. Dan serves on various internal Roche/Genentech work streams related to clinical trial execution and innovation. He holds positions with the Association of American Cancer Institute (AACI) as well as the Society of Clinical Research Sites (SCRS). Dan has presented at various clinical research conferences and has authored multiple peer reviewed publications spanning clinical trial topics ranging from Community Oncology Practices, to overall site/sponsor relationships. Prior to his arrival at Genentech, Dan established his career in oncology clinical trials at various world-leading institutions. His first position was a Research Study Assistant within the Department of Neurology at Memorial Sloan Kettering Cancer Center (MSKCC). In 2011, Dan was recruited to Columbia University Medical Center to become the Clinical Research Manager within the Department of Neurology, Division of Neuro-Oncology. In 2012, he took on a dual appointment between the CUMC Department of Neurology and the Clinical Research Management Office (CRMO) within the Herbert Irving Comprehensive Cancer Center (HICCC). He was instrumental in the creation of an internal QA/Monitoring Division within the Cancer Center.. He subsequently was appointed as the Associate Director, Regulatory Affairs within HICCC, and oversaw all regulatory submission processes, compliance/monitoring/auditing activities, DSMC/PRMC managers, Multi-Site Operations, and IND Office processes, which assisted clinical investigators with correspondence with the FDA. His last site based position was at City of Hope Comprehensive Cancer Center in Pasadena, CA. where he served as the Executive Director of Community & Affiliate Practices, focusing on development of clinical trial infrastructure across 30+ satellite locations across southern California.
Ethan Seville is a clinical research professional who has worked in a wide range of indications across various roles such as patient recruitment, coordinating, quality assurance, management, and regulatory. Ethan is now the Manger of Customer Engagement and Strategic Solutions for Slope.io, which helps researchers by ensuring their network of clinical trial patients get the exact medical supplies their care requires on time, on schedule and on budget.
In this episode, Ethan interviews me 😳.
Kate is the founder and Chief Executive Officer of Innovative Trials, a global patient recruitment organization. Kate has over 20 years of experience in the pharmaceutical and patient recruitment industry while working in clinical operations and patient recruitment positions. Kate is a vocal advocate for equality, diversity and inclusion in clinical research as well as for meaningful community engagement that puts patients and sites at the heart of the clinical research.
This week we discuss awareness vs education, the challenges of physician referrals and the importance of real community outreach.
Scott Stout has been recognized as one of the top healthcare innovators of 2021. While working as a professional investor in high-finance, Scott identified a large gap in the clinical trial marketplace and seized the opportunity to build a team of healthcare, high tech, and venture capitalists to turn his concept of expanding clinical trials, “Beyond Clinical Trial Sites,” into a reality. Prior to founding MedVector, Scott worked with notable companies such as Morgan Stanley and Wells Fargo Private Bank. His entrepreneurial spirit has driven him to help numerous start-ups develop their market-fit, revenue models, capital raises, and go-to-market strategies.
This week we discuss the problem with physician referrals, how more doctors can get involved with clinical research without becoming investigators and how sites can have a more active role in an ever evolving decentralized environment.
Jennifer Bonfrisco has spent over 30 years working in R & D for Pharma, CROs, and Academia. She began her career in preclinical pharm/tox, transitioned to clinical research, and has never looked back. Over the years, some things have changed, but slow patient enrollment and barriers to participation have stayed static.
Trial accessibility was the spark that led Jennifer to create Corlexia Clinical Services. Jennifer spent years finding ways to make trials more patient and doctor-friendly, leading her to create a company dedicated to building customized trial solutions resulting in reaching more medical practices, patients, and families.
Corlexia allows each client to develop a comprehensive cross-functional, patient- and doctor-centric strategy. Identifying the specific needs of patients and doctors creates an early blueprint that results in a more robust, focused clinical development and regulatory roadmap.
Corlexia partners with organizations to enhance their strategy for clinical development, regulatory affairs, and clinical trial marketing.
In this episode we discuss the importance of community engagement, the need for a human connection all throughout the patient recruitment process, and rethinking physician referrals.
Mitchell Hilbe has been involved in clinical research since high school as he was introduced to the industry at a very young age. He carved his own path as a paramedic and EMS instructor for several years before jumping back into clinical research around 8 years ago as a CRA. Mitch is currently working as a Sr. CRA as well as recently co-founding Kenzona Clinical Research earlier this year. Kenzona is a designed as a scalable SMO using Veeva SiteVault. Mitch also founded the Clinical Research Justice League to advocate for better equality and ethics in the clinical trial community.
This week we discuss the challenges of staffing at the site level, how site focused tech solutions can help site owners better manage their business, the pros and cons of starting a site as a CRA, and CRC/CRA relationship dynamics.
Steve Rosenberg's career in life science and healthcare spans more than 40 years. He has led the development and deployment of cloud-based solutions with a focus on driving more integrated approaches to patient-centric trial management.
Steve was most recently Senior Vice President and General Manager of Oracle Health Sciences. Prior to that he was the visionary behind the integrated clinical technology suite introduced by Phase Forward which was acquired by Oracle in 2010. Steve joined uMotif’s board earlier this year.
In his spare time, Steve enjoys summers on Cape Cod with his family. Steve also sits on the board of two residential homes for abused children, and started a non-profit company, The One By One Project with his wife to help people in need in the Boston area.
This week we discuss the state of ePRO/eCOA, the ever changing patient burden and decentralized clinical trials.
Michael J. Koren, MD, is a practicing cardiologist and Chief Executive Officer at Jacksonville Center for Clinical Research, which conducts clinical trials at 7 locations in Florida. He received his medical degree cum laude at Harvard Medical School and completed his residency in internal medicine and fellowship in cardiology at New York Hospital/Memorial Sloan-Kettering Cancer Center/Cornell Medical Center.
He is a fellow of the American College of Cardiology, fellow and two-time president of the Academy of Physicians in Clinical Research, and the regional chapter of the American Heart Association.
Dr. Koren has served as an Investigator in over 2,000 trials and as the international lead investigator for many multi-centered trials including ALLIANCE, ROLE, TREAT to TARGET, OSLER, and MENDEL studies. He has written and co-authored over 100 peer-reviewed articles and been published in the most prestigious medical journals. Dr. Koren has also designed a research training course for physicians now in its 20th year.
On a personal note, Dr. Koren developed a life-long interest in technology and Public Health during his time at The Massachusetts Institute of Technology and The Harvard School of Public Health. He also loves music. He has written two musical plays.
Gunnar Esiason is a cystic fibrosis and rare disease patient leader, who is passionate about early-stage drug development, patient empowerment and health policy. Professionally, he developed a patient engagement platform for a medical nutrition company, built a venture philanthropy practice at the Boomer Esiason Foundation and was the head coach of his high school alma mater’s varsity hockey team. He has consulted on clinical trial development, a real-world evidence population health study, and a cystic fibrosis-specific mental health and wellness screening tool. Gunnar has been the face of fundraising efforts for the Boomer Esiason Foundation, which has yielded more than $160 million for the fight against cystic fibrosis since he was diagnosed with the condition in 1993.
Gunnar holds an M.B.A. from the Tuck School of Business at Dartmouth, an M.P.H. from the Dartmouth Institute for Health Policy & Clinical Practice, and a B.A. from Boston College. He sits on the board of directors at the Boomer Esiason Foundation and No Patient Left Behind.
His health policy opinions have been featured in the Wall Street Journal, USA Today, The Hill, and STAT News.
He currently leads patient-facing strategy at Florence Healthcare.
This week we discuss Gunnar’s experience as a clinical trial participant, decentralized clinical trials, participant reimbursement and so much more.
As CEO of YPrime, Shawn Blackburn provides strategic leadership and direction. Since co-founding YPrime in 2006, Shawn has led the company growth from a two-person consulting firm to a global organization that focuses on evolving technologies to help accelerate development timelines, simplify process complexity, and improve data quality across the clinical development continuum.
With a background in systems architecture and information management, Shawn has built a reputation for helping companies discover insights about future opportunities by bringing together siloed information in meaningful context to support strategic decision making. Prior to YPrime, Shawn had a long career as a technology consultant for Cephalon and Parexel. While at Cephalon, he was instrumental in the company’s development of applications to improve clinical trial workflow and provide deeper visibility into clinical trial performance.
This week we discuss clinical trial technology, the lack of flexibility of many tech vendors, and decentralized clinical trials.
With over 25 years in the Clinical Research field, Michelle has experienced the clinical trial journey from multiple perspectives: patient, caregiver, site, CRO, and Pharma. She has now launched her own company, Innovate In What You Do! LLC, to bring all these together to help others improve their way of working with the user voice included.
As the industry works through the disruptive nature of flexible, device enabled, community focused trials, her years of experience bring value to the multiple players in this ecosystem.
Michelle’s greatest passion, beyond adrenaline sports, is customer focused innovation and responding to the voice of patients/participants, sites, and study teams.
This week we discuss the complexity of breaking down silos, the downside of sponsors customizing everything, and importance of making your voice heard.
Mike Wenger is a software developer who has been building solutions for clinical research for 15 years. Mike worked at the Michael J. Fox Foundation for Parkinson's research connecting Parkinson's patients to clinical studies, built Citeline Connect to connect patient recruitment companies and pharma companies, and is now the founder and CEO of VersaTrial, a platform that reimagines the clinical trial site workflow.
This week we discuss the chaos the clinical trial sites often deal with, how this chaos can impact research participants and how sites can stay better organized with a simple browser extension.
Sylvain Berthelot is the Senior Voice of Customer & Stratefy Director at Calyx, one of the leaders in eClinical and Regulatory technology. In his role, Sylvain aims to transform customer feedback into insights and decisions that will positively impact trial teams, sites and patients.
Sylvain has assumed various roles during his 12+ years at Calyx, and he consistently kept his focus on reducing burden for sites and patients. He is the host of the podcast Calyx Café, where industry experts talk about clinical research trends, futurology, and best practices to reliably solve the complex in clinical trials
This week we discuss the often underappreciated role of IRT in clinical trials, the concept of “site approved” technology, and the zen of surfing.
Archana Sah is a clinical development thought leader with extensive (30 years) experience and passion for developing medicines for patients having led and contributed to 15 FDA/EMEA drug approvals in Oncology, Immuno-Oncology, Precision Therapeutics, Rare Diseases, Metabolic Diseases and Women's Health. She has held various global positions within biotech and pharma including Genentech/Roche, Bayer Oncology, Johnson & Johnson, ICON, two Oncology biotech start ups and a Digital tech company Medable where she led Oncology TA Solutions. She is now the Founder and CEO of AS Pharma Advisors and provides strategic advisory services to several organizations in clinical development and operations and innovations in digital health technology.
She is a recognized leader/change agent passionate about bringing innovation and efficiencies within the entire clinical trial ecosystem as an advisor and speaker. She has been the co-founding chair (2019-2021) and now a member of Society for Clinical Research Sites Oncology Board and chaired the Annual Oncology Summits. She serves on the Leadership Council for Decentralized Trials and Research Alliance and has been a member of the Digital Innovation in Oncology Roundtable with DiMe. She also serves as an Advisor to American Cancer Society Cancer Action Network. She has contributed to the clinical trial sites Standardization and Harmonization with the Forum on Drug Discovery and Development, National Academy of Sciences.
This week we discuss the unique challenges of implanting DCT in oncology, the ever-present need for better interoperability, and what the next 5 years of DCT might look like.
Dr. Leigh J. Mack, was clinically trained in trauma and plastic surgery and is boarded as clinical research physician. He has designed many trials in the areas of pulmonary devices, aesthetic medicine (injectables), infectious disease nano-particles, medical lasers and other devices. He was recently a physician advisor to a 20-hospital healthcare system in utilization review and appeals. He has designed an automated software system for participant recruitment that employs RPA to search 100,000s of EMR records in a few days time to meet potential participants for clinical trials. In 2021, he left the position of Chief Medical officer for Crucial Data Solutions and started to develop his own clinical trial software that employs RPA, micro-services and block chain type technology. He also severed in the SC State Guard as the G-7 Civil Affairs officer.
This week we discuss what protocol development can learn from military planning, using AI to identify clinical trial participants and the role of pharmacogenetics in clinical trials.
David Grew is a practicing radiation oncologist and the founder of PRIMR. PRIMR creates IRB-ready digital patient education content for clinical trials by pairing board certified physicians with graphic designers and patient advocates. He practices medicine at a Yale-affiliate cancer center in Hartford, CT.
In this episode we discuss how patient education happens at research sites, how to keep patients engaged through ongoing education, and how video content can improve patient care.
Ardy Arianpour is CEO & Co-Founder of Seqster the leading healthcare technology company that puts the patient at the center of all their health data. He is a visionary health tech executive with 20+ years driving innovation in biotech and digital health.
Prior to starting Seqster, Ardy launched several clinical and consumer-based genetic tests as CCO of Pathway Genomics, and served as SVP of Ambry Genetics, which sold to Konica in 2017 for $1 Billion.
As a key player in the 2013 landmark SCOTUS decision scrapping gene patents, Ardy played an instrumental role in expanding genetic testing access with the launch of BRCA testing benefiting patients and family members across the country.
Ardy received his BS in Biological Sciences from UC Irvine and an MBA from Marshall Goldsmith School of Management. He was a Medical, Marketing, and Media’s (MM&M) Top 40 Healthcare Transformer and San Diego Business Journal 40 under 40.
In this episode we discuss health data silos, the history of Seqster, digital front door use cases, and which Metallica album is best.
Andrea Valente spent the past 20+ years building global clinical trial tech organizations and technologies. Recently, Andrea was named CEO of ClinOne, a company that offers a virtual clinical trial platform for patients.
Jennifer Peters had an idea to streamline payments between clinical trial sponsors and investigators, so she co-founded a company called Greenphire in 2008 which was acquired for $1.1 billion in 2021. She is also Board Chair of ClinOne.
In this episode we discuss the relationship between patients and sites, the role of protocol design on participant engagement/retention, the technology adoption cycle, empowering patients by empowering sites, platforms vs interoperability, and the value of more women in leadership roles in clinical research.
Brittany Sloan is the Director of Black Research Matters, a safe space exclusively for Black people to learn more about research with the purposes of being becoming better-informed decision-makers thus strengthening the community by using knowledge as a tool to navigate the medical and healthcare systems.
This episode is part 2 of a 3 part series on the Tuskegee Syphilis Experiments presented by Brittany.
Dr. Daniel Fox is a translational scientist with over fifteen years of experience in research, business development, and administration. He worked in academia, small startups, global giants, and finally in site administration where he found a particular passion to help physicians to get what they need for optimal research. Dr. Fox is the founder of the Clinical Research Payment Network and an advocate for the site's legal and financial rights
In this episode we discuss the biggest budget and contract issues facing clinical research sites, industry fragmentation and how to change the site/sponsor dynamic when it comes to contracting.
Joe Dustin is Vice President of Product Strategy and General Manager for eCOA and Decentralized trials at Medable.
He is responsible for the go-to-market strategy around Medable’s solutions and is working to define what decentralized trials will become with the professionals who are living it every day.
For 20 years, Joe has been in the Clinical Trials Industry at the intersection of Technology, Innovation and Science. He has held a number of roles in IT, Project Management, Solution Consulting, Product Development and Sales at tech companies like Medidata and CRF Health, and most recently was the Head of Clinical Innovation and Change Management at Bristol Myers Squibb.
In this episode we discuss decentralized clinical trials (duh), the financial implications for sites, the disconnect between sponsor, vendor and site, the value proposition of site technology, and so much more.
Derk Arts has 15+ years of experience in medicine, research, and technology. He founded his company - Castor to solve the biggest issues in clinical research: a lack of inclusivity, patient focus, and impact of data. Castor enables sponsors worldwide to run patient-centric trials on a unified platform that helps them maximize the impact of research data on patient lives. Derk believes the key to achieving lasting change in the industry is through scalability and standardization.
In this episode we discuss the current state of clinical trial technology, standardization of clinical trial data, the unleveraged power of research sites and the future of the CRO industry.
A technologist with over 23 years of industry experience, Raj Indupuri is responsible for establishing the eClinical Solutions vision and future-looking technology strategy. He is deeply passionate about fostering innovation to revolutionize the Life Sciences industry with ground-breaking technologies that will modernize clinical trials and bring treatments to patients faster. As an industry veteran who has been part of the evolution of Life Sciences and clinical data management for over two decades, Raj has an astute business vision to realize the digital future and enable progress and potential with data and analytics at the core of the company’s innovative products and solutions. Raj is responsible for the overall direction and management of the company and is a Mechanical Engineer with an MBA from Boston University who firmly believes data is the new fuel that will drive human progress.
In this episode we discuss clintech interoperability, sites leveraging their own technology, data fabric, and the future of clinical trial technology.
Beth Baldys, as inVibe’s Head of Listening, is responsible for helping clients better understand their key stakeholders through deeper and more thorough listening. In addition to bringing patient voice to the forefront, she also works closely with the team to translate research findings into strategic and actionable insights for clients.
Beth is a sociolinguist whose graduate research focused primarily on medical discourse analysis, which she continued to pursue throughout her entire career in market research. She brings 10+ years of experience, including past work analyzing doctor-patient communication. Her research has contributed to publications in Pain Medicine and The Journal of Cancer Education, as well as a recent acceptance to the CHEST 2021 Annual Meeting.
In this episode we discuss the secret language of clinical trials, how to better communicate with research patients, reducing burden for patients and InVibe’s recent acquitision by THREAD Research.
Brittany Sloan is the Director of Black Research Matters, a safe space exclusively for Black people to learn more about research with the purposes of being becoming better-informed decision-makers thus strengthening the community by using knowledge as a tool to navigate the medical and healthcare systems.
This episode is part 1 of a 3 part series on the Tuskegee Syphilis Experiments presented by Brittany.
Joel White is an independent consultant who founded Marketcap Consulting in June 2021 to help organizations, particularly those in the clinical research industry, improve their pricing, profitability, cash flow, and financial operations. Previously, Joel worked for about 15 years across large and small CROs leading various functions in proposals, pricing, finance, and contracting.
In this episode we discuss so many site level budget and contract issues including pricing, cash flow and contract negotiations. This episode is packed with value for research sites.
Bree Burks is an ICU nurse turned clinical researcher turned technology enthusiast. She is currently the Vice President of Strategy, Site Solutions at Veeva Systems.
In this episode we discuss the lack of practical training for clinical research sites, the frustrating universe of point solutions in clintech, the growing need for standardization in site operations and so much more.
Alex Yant is a Solutions Coordinator for Slope, the industry’s first eClinical Supply Chain Management software. He works to add order, trust, and predictability to your clinical research trials, so they end on-time and on-budget. Alex has four years of healthcare experience, as both clinical research professional and a direct service provider. He holds a bachelor’s degree from the University of Wisconsin-Madison, and a Master of Science in Occupational Therapy from the University of Illinois at Chicago.
In this episode we discuss the significance of diversity of experience in clinical trials, the role of sites in clinical trial inefficiency, and the complexity of managing site lab inventory.
Barry Lake is the CEO of Devana Solutions, guiding the growth and expansion of the leading and most innovative software platforms for the clinical trials industry. Barry is a successful entrepreneur who has started and successfully grown several businesses over his career and has been actively involved in the healthcare space for well over a decade. Barry originally bought a site network with the intention of cashing out on the current site-consolidation trend fueled by private equity but pivoted to SaaS when he saw the need. Devana Solutions is driven by a core belief that performance data transparency through technology is critical to the selection of top-performing research sites and organizations to align with pharmaceutical sponsors and CROs to reduce drug development costs and cure disease.
In this episode we discuss the fragmentation in the clinical trial industry, the limitations of CTMS, and the importance of sites tracking their own metrics.
Zina Sarif is a Cancer Scientist and Founder of Yendou. Yendou is on a mission to speed up clinical trials delivery from months to weeks and become a global community of principal investigators, patients and sponsors. Yendou connects healthcare innovators (sponsors) with healthcare providers and make clinical trials access and delivery for all sides only few clicks away.
In this episode we discuss Zina’s journey from the lab to clinical trials, the mounting inefficiencies that plague our industry and the significance of site engagement.
Doug Bain has been developing, implementing, and supporting clinical research systems since 1996 with a primary focus on EDC and DCT solutions. He was the founder and CEO/CTO of Clinpal, a DCT Platform. Since 2019, Doug has been the Chief Technology Officer at KCR - a mid sized global CRO.
In this episode we discuss why clinical trial systems are so siloed, platform overload at sites, the future of decentralized clinical trials and the industry’s reluctance to discuss their failures.
Jasmyn Adams is the Founder of The Clinical Research Associate Solution, LLC, an organization that provides career coaching for CRAs and aspiring CRAs, as well as CRA consulting, speaking, & workshop services for clinical research organizations. Jasmyn is also a Senior Oncology CRA, CRA Career Strategist, Speaker, and Podcast Host of Confessions of a CRA. Her dream is to make the CRA career so well known that it becomes one of the most common responses for children all over the world to the question, “What do you want to be when you grow up.”
In this episode we discuss the effects of CRA turnover, the transition from bench to bedside, and the challenge of retaining site level talent.
Today we welcome back friend of the show Jane Myles, VP Innovation at Curebase. Decentralized clinical trials are talked about so much nowadays but, all too often, we are left to guess whether they perform better or worse than hybrid and brick and mortar trials.
In this episode we examine a real life example of a DCT in action including metrics against hybrid and brick and mortar sites in addition to addressing some of the myths that surround DCTs.
Arti Bhosale is a Dentist turned Clinical Researcher. After completing dental school in India and moving to the US, Arti initially planned to continue in clinical dentistry. While completing her Master's degree she had the opportunity to be involved in oral cancer research and since then has made a conscious choice to continue in clinical research. 12 years have passed and Arti has held roles at site and industry levels. Arti is also the confounder of Sieve Health an AI/ML/NLP based advanced Clinical trial matching platform designed to benefit multiple clinical trial partners by enabling faster and diverse patient recruitment with enhanced accuracy.
In this episode we discuss the complexity of subject recruitment, inclusion of community practices in clinical trials and the growing power for sites to choose their own technology solutions.
Mark Shapiro is the COO of xCures and principal investigator for XCELSIOR and BEAT19, two patient-powered real-world data and outcomes registries in cancer and COVID-19, respectively. He has been focused on innovation and growth in clinical research for more than 20 years. Prior to joining xCures, Mark was SVP, Operations for a global CRO where he was responsible for a team of about 500 drug development professionals in 30 countries, and a portfolio of more than 100 active clinical trials. In his role at xCures, he has been focused on developing and implementing AI and Machine Learning-enabled software systems for clinical research.
In this episode we discuss the strengths and weaknesses of decentralized clinical trials, the dilemma of patient referrals in clinical trials, and the challenges of scaling research site networks.
Rick Greenfield is the CEO and founder of RealTime Software Solutions, a leading Clinical Trial Management Systems provider. Rick also co-owned and managed one of the largest multi-specialty research sites in the US for nearly thirteen years where RealTime-CTMS was first created and implemented to streamline site operations for all staff and processes. RealTime, today, is bringing even more advancements to sites and sponsors that include eCONSENT, a Global Patient Portal to support fully or hybrid decentralized clinical trials and much more.
In this episode we discuss the historical undervaluing of research sites, site’s role in decentralized clinical trials, and future of system interconnectivity and much more.
Our guest this week is Jane Myles (with an occasional guest appearance by her canine friend). Jane is a self-proclaimed clinical trial operations nerd. She’s had the opportunity to work on global drug development programs across many therapeutic areas but calls Hematology/Oncology her TA home base. Jane switched from molecule focus to portfolio focus about 12 years ago, first focused on patient recruitment, then patient voice and input, then patient facing technology and it's adoption. She’s able to merge them all together in her current role as VP Innovation at Curebase, building DCT technology and services to drive access and inclusion to trials.
In this episode we discuss the tall order of standardizing definitions in decentralized clinical trials, the role of sites in technology adoption, Jane’s role with DTRA, lessons learned from the beach, and so much more.
Mel Hardman is a Certified Clinical Research Professional (CCRP) with over 15 years of progressive healthcare leadership and clinical research experience who has found her niche in site and investigator engagement, clinical trial patient recruitment and retention, protocol evaluation activities. Mel spends a lot of her time strategizing ways to improve diversity in clinical trials, closing the patient to science gap, and increasing awareness and visibility of clinical trials in communities of color. She has also consulted with start-up companies to improve their knowledge of optimizing recruitment funnels for technical platforms.
In this episode we discuss the complexity of protocol amendments, participant enrollment challenges and their downstream effects, and true community engagement.
Deena Bernstein has been involved in the clinical research industry for 22 years. Her first 20 years were spent operating and developing site networks for large healthcare organizations, CRO's and IRO's. Currently Deena is the VP of Customer Success at Datacubed Health, a technology solutions provider.
In this episode we discuss reducing site burden, gamification in the ePRO/eCOA space and the ever present silos in clinical research.
Rob Bohacs is the Founder and Chief Solutions Officer of ClinOne, who works with world-class pharmaceutical companies to rethink and redevelop how clinical trials should be managed, with patient centricity at their core. Rob believes it is time to completely alter how we manage research site and patient interaction by bringing trials directly to patients to simplify a very complex process through technology and automation. In this episode we discuss site empowerment, the importance of measuring the patient experience and using decentralized clinical trial methods to strengthen the site and patient relationship.
Matt is the CEO of Trialbee, the leader in technology based patient matching, engagement and enrollment for clinical trials. Matt started his career as a software engineer and has been bringing innovative platforms to the Life Sciences market for the past 20 years. Prior to Trialbee Matt founded NextDocs, a venture-backed platform for regulatory and clinical document management and grew the company to 100 customers across North America, Europe and Asia before selling the company in 2015.
In this episode, we discuss the goldrush in patient recruitment solutions, how sites manage technology, Facebook’s recent changes to targeted advertising, the importance of mentorship and the beauty of failure.
Today we’re deviating a bit from the standard podcast format and delving more deeply in to one topic – decentralized clinical trials. I feel we see a great deal of conversation around DCTs from sponsors, CROs and vendors but not as much from the sites themselves. This is my humble attempt bring the site voice a little bit more to the forefront in an increasingly overcrowded space.
Our site voices today are Joy Jurnack and Dr. Viviënne van de Walle.
Joy has a long and diverse career in clinical trials that includes roles as a clinical research nurse, research subject advocate, IRB member, and ACRP fellow. Joy’s recent passion is now how decentralization of the clinical research enterprise can include both innovation and products available to expand, develop and implement this progress to include considering DCT as an extension of the clinical research site.
Viviënne is a physician by training who studied medicine both at the University of Maastricht and at the University of Oxford. She has always combined clinical research with patient care and has been a full time principal investigator at independent clinical research sites. She co-founded and owns the independent research site PreCare Trial and Recruitment in the Netherlands.
In this episode, we discuss decentralized clinical trials’ influence on PI oversight, site budgets, vendors/portals, and so much more!
We welcome back friend of the show, Adam Brown. Adam currently serves as the Chief Executive Officer at ClinArk and advisory board member at the Wittenberg Institute for Public Humanities and Sciences. Prior to founding ClinArk, Adam spent his entire career developing clinical trial strategies at some of the largest contract research organizations (CROs) in the world. He has a passion for increasing clinical trial awareness and access.
In this episode, we discuss community engagement, the effects of COVID on clinical trials, and the continued rise of decentralized trials.
Adam Walker is a passionate biometrics subject matter expert with global exposure to the Pharmaceutical industry, having held a number of global Biometrics leadership roles within the pharma and the clinical arena. He is also co-host of the Huxley Morton Podcast, where he speaks to Pharma & Biotech Industry leaders and shares their stories of personal and professional growth.
In this episode, we discuss the value of relationships, growth in the clinical research industry and the importance of self-awareness.
David LaHaie is the founder and co-owner of Great Lakes Research Institute (Detroit, MI) and West Valley Research Clinic (Phoenix, AZ). After spending over a decade in biotech business development he pivoted to clinical research site ownership and established a niche creating urban multi-specialty clinics and bringing clinical trial access to the underserved.
In this episode, we discuss the transition from basic science to clinical trials, the benefits/downsides of various site models and the importance of incremental improvement.
Richie Kahn, MPH, is a health policy professional by training, clinical researcher by trade, and patient advisor by necessity. He is passionate about incorporating patient and caregiver perspectives into the clinical development process and ultimately reducing the time it takes to bring promising new therapeutics and diagnostics to market.
In this episode we discuss what clinical trials can learn from public health, the importance of community engagement and the ongoing role of technology in decentralized clinical trials.
Brittany Sloan spans 13 years of clinical research roles, personal leadership responsibilities and experiences, securing a robust career for herself while making notable contributions to research. Most recently, she's been on been on leave, reconfiguring her next steps for the future, especially through the lens of being a women of color.
In this episode we discuss emotional intelligence in clinical research, the importance of a good team and the origin and mission of Black Research Matters.
Danielle Coe is an experienced Clinical Research Professional who is bringing diversity and much-needed change to our industry. She has helped countless professionals increase their reach and opportunities through Black Women in Clinical Research (BWICR) and Black Men in Clinical Research (BMICR). Presently, the organization has over 5,700 active members. The mission is to educate, empower, support, and help Black women and men thrive in the clinical research industry.
In this episode we discuss Danielle’s journey from lab to clinic, the lack of diversity in the clinical trial workforce and the importance of marketing yourself.
Patient recruitment is still the crux of any successful clinical trial. In this series, we get tips, tricks and feedback from members of the clinical research community who are actively involved in patient recruitment efforts.
In this episode we have Christine Narro, who discusses the importance of recruitment and it’s downstream effects, Ashley Heard who provides some insight to help increase subject diversity and Dr Christopher Gantz who discusses tips for developing a centralized recruitment program at the site level.
Jay Pitts is the President and CEO of ClinCept, a clinical research company committed to providing clinical research studies to communities across the Southeastern U.S.
In this episode we discuss the importance of community engagement, customer service in clinical trials, and true patient centricity.
Elizabeth Weeks-Rowe, LVN, CCRA, has 21 years of clinical research experience, including work as a study coordinator, CRA, CRA Trainer and CRA manager. She has been an Association of Clinical Research Professionals (ACRP), Certified Clinical Research Associate (CCRA) since 2004. She is a frequent speaker at clinical research industry conferences as well as a requested speaker at both ACRP and SOCRA local chapter events. She is a staff instructor for Clinical Research Fastrack, and works as a Principal CRA in study start up for a global CRO.
In this episode we discuss the evolution of clinical research education, the importance of mentorship and not letting perfection prevent progress.
The clinical trial site community has spoken. Help us build a place where sites can come together to support one another, talk shop and share their experiences. Join us on Clubhouse on September 21st at 11:00 AM Eastern.
Tiffany Ashton, from ClinEssentials, has been in the clinical research industry for over 18 years, holding positions such as Clinical Research Coordinator, Clinical Research Associate, and Clinical Trial Manager.
In this episode we discuss tips for making the jump from CRC to CRA, the importance of relationship building and leveraging your network, and the significance of continual development and reflection throughout ones career in clinical research.
Donna Symanietz has a wealth of experience in medical sales and has trained colleagues, patients, nurses, and physicians on new treatment options and skills with new medical devices and pharmaceuticals.
In this episode we discuss her transition in to clinical research, what sites can learn from sales and I unsuccessfully try to convince her to open her own site.
John Reites is an executive intrapreneur turned digital health entrepreneur whose career includes over 18 years leading global drug development, clinical research and decentralized trials for life science organizations. As CEO of THREAD, he is leading efforts to change the way clinical research is conducted, focused on decentralized approaches.
In this episode we discuss John’s experience as a clinical trial participant, lessons learned from Disney World and the current state of decentralized clinical trials.
Adam obtained his Bachelor of Arts from Wittenberg University in Biology. He currently serves as the Chief Executive Officer at ClinArk and advisory board member at the Wittenberg Institute for Public Humanities and Sciences. Prior to founding ClinArk, Adam spent his entire career developing clinical trial strategies at some of the largest contract research organizations (CROs) in the world. He has a passion for increasing clinical trial awareness and access.
In this episode, we discuss diversity in clinical trials, the importance of building trust, and the role of education and transparency in clinical research.
Trevor Cole is a manager for a research quality, monitoring, and regulatory affairs service line at Children’s Mercy Research Institute in Kansas City, MO. Prior to this role he has worked as a CRA/CRC in Oncology, CRC in gastroenterology hepatology and nutrition, managed a multispecialty health clinic, and worked in an emergency room. He holds a CCRC through ACRP and is currently working through nursing coursework which he will complete in December 2021.
In this episode we discuss exposure to clinical research as a career at a young age, the lack of standardization and the top-down nature of the clinical trial industry.
Laura R. Holtz, MS, PMP, CCRP, is a Senior Research Manager at Indiana University Center for Aging Research and Regenstrief Institute. She oversees multiple federally funded grants and investigator initiated research trials includes projects with cognitively impaired older adults in the community and nursing facility settings. As a research staff advocate, Laura established the Indianapolis chapter of SOCRA, the Society of Clinical Research Associates, which provides education opportunities for staff to become Certified Clinical Research Professionals. She has presented several times at the SOCRA annual conference and SOCRA chapter meetings. Her dedication to research education earned her seat on the SOCRA Board of Directors in 2018 to present.
In this episode, we discuss the continued emphasis on being a generalist, the idea of clinical research as customer service and the importance of authenticity in communication.
Daniel Perez is the Chief Operating Officer at MACRO Trials, a Site Optimization Organization (SOO) dedicated to providing the institutional infrastructure to perform the highest quality clinical trials across all specialties and private settings. At MACRO, Daniel combines his operational acumen with research and regulatory expertise to help bring its vision into a tangible reality. He leads MACRO’s operations by constantly challenging the status quo, and continuously evaluating the clinical trial process through the lens of the patient. Daniel also serves as a founding board member for Clinical Trials in Color, a 501(c)(3) non-profit foundation with a mission to improve health outcomes in communities of color by increasing diversity and access to clinical trials.
In this episode we discuss Daniel’s circuitous road to clinical research, the ability for lean organizations to better access underserved communities and the importance of self-development in clinical research.
One thing can be said for Edye Edens - she’s passionate.
Edye is a licensed attorney with an international human rights, research ethics, and health law background. She spent almost a decade in-house within the academic medical center research compliance environment before transitioning to consulting in 2017. Her consulting areas with First Class Solutions, Inc., include research administration, healthcare compliance, grants, contracts, IRB, COI, education, privacy, HIPAA, multiple areas of FDA compliance related to drugs, devices, and food; AAHRPP, misconduct and site-level compliance work as it relates to QA, monitoring, and auditing (particularly oncology).
Esthefany Jabbour’s research career started in early 2013, working in regulatory affairs at a site level. In the last few years, she has gained experience in multiple roles at a site level from clinical research coordinator to chief Operations Officer. Her role as a COO at a research site oversaw the site network operations, recruitment, training, business development, and day-to-day structure and management. Her passion in clinical research and business has grown over the years and allowed her to expand her knowledge in multiple therapeutic areas. Recently, she started her own multi-specialty clinical research site in Boca Raton, FL. FWD Clinical Research is data driven site that focuses on delivering quality clinical trials to sponsors.
In this episode, we discuss the challenges and complexity of starting your own research site.
Our guest today does not come from the clinical research world, but instead offers an invaluable service to sites and networks. Brandy Bailey, MA, Director of Strategic Growth for SendaRide has a bachelor’s degree in business administration from Northeastern State University and a master’s degree in gerontology from the University of Central Oklahoma where Brandy graduated with honors. Brandy is currently pursing her second graduate degree, a masters in business administration from Southeastern Oklahoma State University.
Jesyln Atanu is a highly dedicated research professional with a range of experience from patient recruitment to working as a CRA, mentoring clinical researchers, and training Clinical Research staff on key subject matters. Jeslyn runs a clinical research service, HTex Clinical, that assists research sites in meeting their recruitment goals by providing them with protocol specific patient recruitment & retention consultation.
In this episode, we discuss specialization vs generalization (shades of Dan Sfera), the advantages of networking to acquire knowledge, and the significance of approaching your clinical research career (and life) with openness. This has been one of my favorite conversations to have and Jeslyn is truly an inspiration in the field.
Mario Sierra has a background in biochemistry and business. He currently works at Research Source as a clinical research coordinator and Business Strategist at Paramount Research Network. I’ve had the pleasure of getting to know Mario outside of the podcast and he has a bright future in the clinical research industry.
In this episode we discuss his purposeful entry into clinical research, the adoption of e-source, and the slow adoption of technology across clinical research.
Ethan Seville is a clinical research professional who has worked in a wide range of indications across various roles such as patient recruitment, coordinating, quality assurance, management, and regulatory. Ethan is now the Senior Director of Site Engagement for Slope.io, which helps researchers by ensuring their network of clinical trial patients get the exact medical supplies their care requires on time, on schedule and on budget.
In this episode we discuss innovation at the site-level, collaboration with larger institutions and how Slope.io can help sites manage their supplies, documentation and beyond.
Kim Talbot is the founder of PRN of Kansas, a multi-specialty, stand-alone research site in Wichita Kansas. Kim has a BSN from Wichita State, and has been an APRN since 2001.
In this episode we talk about the importance of developing a diverse study pipeline, what makes a good research coordinator, and the day-to-day of a research site owner.
Jeffrey Smyth is the VP/COO for MOORE Clinical Research in Tampa, Florida. He has held the position since 2011 and has a Master’s in Healthcare Administration.
Jeffrey and MOORE Clinical Research have recently implemented an e-source solution across their company. This episode discusses the challenges, rewards and issues involved with implementing e-source.
Lucia Rodriguez and Bianca Garcia have worked in clinical research for well over 20 years combined. They’ve held just about every site-level title and worked across all phases, multiple therapeutic areas, and numerous. Basically - these ladies know their stuff. Recently they have teamed up to star their own company - Absolute Clinical Research. Absolute Clinical Research offers an individualized, customer-focused approach to clinical research management while maintaining patient safety and protection, protocol adherence, quality of data as top priorities.
In this episode we discuss the importance of constant communication, starting your own company while working full time, investing in your staff, and why you should always be prepared.
Mone’ Brown is a well rounded clinical research professional who has a passion in many different areas of clinical research. Her passion is Regulatory Affairs in addition to monitoring. She has held roles from Regulatory Affairs Document Specialist, Clinical Research Coordinator as well as Project Manager. She holds a Master's of Science in Regulatory Science. She was unfortunately laid in March of 2020. Someone hire this woman before it’s too late!
In this episode we discuss the jump for CRC to CRA, the delicate balance between quantity and quality, the value of diversifying your experience, the challenges of job hunting during a pandemic and the importance of integrity.
Dan Sfera is the Clinical Trials Guru. Dan has been publishing content in the clinical research space since 2010. Dan runs a clinical research consulting firm, operates multiple sites and also operates a CRO. The man has just about done it all when it comes to clinical research.
In this episode we discuss his beginnings in clinical research, learning when to pivot, our shared affinity for Gary Vaynerchuk, hiring for potential vs hiring for experience, and the importance of becoming a generalist.
John Bowman is a 2017 graduate from Washington and Lee University with a BS in Biology currently working in Charleston, SC as a clinical research coordinator . His goal is to become an MD with an emphasis on clinical trials as well as conventional medicine.
In this episode, we discuss clinical research as a path to becoming a surgeon, pediatric trials vs older populations, the importance of preparation, building trust with your patients, and building a routine.
Jeannie has worked in clinical research for 20 years across multiple therapeutic areas including gastroenterology, ophthalmology, neurology and endocrinology. Her experiences range from study coordination, clinical care and conduct, regulatory oversight, site operations, on-boarding and training, and site management. She is currently a Research Compliance Analyst at Banner Health and the Phoenix Chapter Chair for SOCRA.
In this episode we discuss the increasing use of telehealth, training new coordinators, SOCRA vs ACRP, the exciting world of research compliance, why data quality is so important and the importance of asking questions.
Our guest today is Lorraine Dishman. Lorraine is a diligent and detail-oriented clinical research professional who is passionate about supporting the advancement of scientific discovery. She oversees the clinical trial process from start-up to closeout and has held roles from clinical research coordinator to clinical research project manager. She’s worked in academic institutions, third-party sites and the Department of Health and Human Services.
In this episode we discuss being furloughed due to COVID19, creating relationships within clinics, academic vs independent research sites, and the importance of using this downtime to improve your skills and knowledge.
Show notes available at www.notetofilepodcast.com
Today we welcome Kartik Munshi to the podcast. Kartik is the Research Operations Manager for the Cardiovascular Medicine Department at the University of Kansas Medical Center. I’ve known Kartik for several years and we worked together previously at the Oklahoma Heart Hospital Research Foundation. He’s been in clinical research for 10 years and has worked in a number of positions from clinical research coordinator to QA and compliance.
In this episode we discuss opening back up in the time of COVID-19, learning to let go of mistakes and how important it is to document, document, document!
Kartik can be found at LinkedIn here: https://www.linkedin.com/in/kartikmunshi/ and emailed at Kartik.Munshi@gmail.com
For full show notes with screen shots, please visit our website at http://www.notetofilepodcast.com
When I first started in clinical research, I worked for a well-established neurology department at a university. At the time, it seemed like studies just flowed in without having to pursue them - until they didn’t. Faculty came and went. Research staff had turned over. Suddenly, we needed studies - bad!
At the time, I had no idea what I was doing. I took to clinicaltrials.gov and started sorting, reviewing and emailing any and all contacts that seemed appropriate. It was a tedious process. My response rate was abysmal and most the replies I did manage to get were saying the study was not adding sites. However, over time, I did manage to bring in some studies and get things slowly back on track.
This is a method that I still use today. Everyone should. Truthfully, it is often no less frustrating. I have managed to make some beneficial relationships and land some great studies though. One thing that made the search so much easier was creating an RSS feed that sent me all newly posted studies. I didn’t have to spend as much time filtering through every study every day.
Here are the steps for setting up an RSS feed so that you can spend less time clicking around on ct.gov:
Step 1: Navigate to www.clinicaltrials.gov and click on “Advanced Search”.
Step 2: Enter your search criteria. I would recommend keeping it fairly loose so that you capture all possible study opportunities. Hit “Search” once complete.
Step 3: You will be brought to your results. On the top of the results, to the far right, you will see “Subscribe to RSS.” Click the link and a new page will be opened.
Step 4: You will be presented with an option as to which type of feed you want. I prefer to include modified studies as a study may reopen to enrollment and I want to ensure that those studies make it in to my feed.
Step 5: The page that comes up next will look like a bunch of code and gibberish. From here, copy the link in the address bar. This is the link you will paste in to your reader.
Step 6: Add the URL to your RSS reader. At this point, your feed can be read in whatever reader you choose. Even Microsoft Outlook has an option to add RSS feeds. All studies that match the search criteria that you entered will be fed straight in to Outlook. You can read how to set that up here. If you choose to use a different reader, a quick Google search will turn up how to add feeds to your reader. I personally use Feedly as my reader as it also pulls in any news sites you wish to add. From here I can keep up with the latest news and any new leads from clinicaltrials.gov all from one place.
That’s it. Pretty easy, right? However, this has made a big impact on how much time I spend trolling around ct.gov. What are your tips and tricks for better utilizing ct.gov?
The informed consent process is generally the first impression that subjects make with your research site. As a result, the importance of how the process is manged is of the utmost importance. Here are some quick tips for how to simplify the informed consent process.
In addition, I would encourage all sites to consider the informed consent process a first impression for potential clinical trial participants. Put yourself in the subjects shoes: would you participate in a trial that your site was offering?
I learned very quickly that relationship building is super important and dangerously underrated in clinical research. The relationships you forge (or don’t) with your PI, subjects and CRAs can make all the difference.
Here are some simple, easy ways you can start strengthening your relationships and how they can benefit you in the long run.
I always say “no one sets out to be a clinical research coordinator”. It’s often the type of job that people just fall in to. As a result there are ridiculously diverse backgrounds of clinical research staff - from high school graduates to MDs!
So what really makes a successful research coordinator? It’s not necessarily credentials or education. I always look for soft skills first when hiring new research staff. Why? The technical aspects of clinical research can be always be trained. In fact, many experienced coordinators have picked up bad habits along the way in their careers. As a result, I often find it’s best to start from scratch.
Focusing on finding applicants with these soft skills just may help you land your next successful research coordinator.