Calyx Cafe: Recent Episodes
CALYX
Calyx Café is an interview series that brings together industry experts to discuss clinical research trends, futurology, and best practices to reliably solve the complex—all within the time it takes to drink a cup of coffee. Sylvain Berthelot, Solutions Consultant Director at Calyx, hosts the series and has a knack for highlighting the extraordinary.
In this episode Rob Delaney, Assoc. Director of Clinical Supply Systems at Regeneron discusses what it takes to form successful sponsor/vendor relationships. Focusing on three critical elements: quality, customer service, and transparency, he explains why sponsors need to hold themselves to the same standards as their service providers in order for partnerships to work.
RECIST expert Dr. Oliver Bohnsack discusses a recent study that demonstrated the survival benefit to a subgroup of patients when irRECIST is used instead of RECIST 1.1 for image assessment in solid tumor trials, as irRECIST takes the entire tumor burden, including new tumor growth, into consideration.
In this episode, Brad Hightower of Hightower Clinical Research discusses the benefits of partnering with private practices to diversify clinical trial landscapes and ultimately enroll more clinical trial patients, faster.
In this episode, Willie Muehlhausen discusses how advances in Artificial Intelligence can improve patient eCOA interactions, simplify their #clinicaltrial participation and deliver more valid data to study sponsors.
In this episode, Jen Stewart, ED Clinical Data Science at Premier Research explains the data management considerations of today’s decentralized clinical trials and how the industry could benefit from more transparency into outcomes and lessons learned as we strive to leverage remote technologies to accelerate clinical development in a post-pandemic era.
In this episode, Astra Zeneca Head of Technology Alliances, Kay Smith discusses sourcing eClinical solutions in the ever-changing tech landscape and how sponsors and providers can work together to reduce patient/site burden during clinical trials.
Sr. CRA Tom Miller discusses why clinical trial sponsor’s and investigative site’s objectives may not align and suggests how technology and open communication can bridge gaps to ensure both organization’s success.
Calyx’s Craig Mooney reflects on recent changes in the regulatory landscape that emphasize the investigative site’s ownership of IRT data collected during clinical trials, and considerations for sponsors and solution providers for making progress toward this goal.
Calyx’s Liz Dalton discusses how CROs and their partners can best work together to find the solution to the industry’s ongoing clinical development challenge: How can we move faster, yet still safely, to bring new drugs to patients faster?
Rho’s Steve Palmatier describes how partial unblinding occurs and how advanced IRT systems can reduce these very real risks to ensure data quality isn’t compromised.
Merck’s Joseph McDonnell and Jeffrey Timmons discuss the company’s spinoff of Organon, how the separate organizations are creating value for all stakeholders, and why they’re excited about the role of technology in streamlining the regulatory process.
Karen Harry explains what market authorization holders can expect as they prepare to transition their Centrally Approved Product (CAP) submissions to IDMP Iteration 1.
Hear from Willie Muehlhausen about the growing usage of BYOD, patient preferences, and what regulators have to say about this approach to collecting PRO data in clinical trials.
In this episode, Morris Panner of Ambra Health talks about first-time quality and how the continuous bursts of innovation in agile cloud technology and AI are opening opportunities to progress clinical research and enable greater access to healthcare.
By leveraging today’s data capture technologies –like advanced medical imaging –HCPs can enhance measurement quality and capture real-time data points to intervene before patients leave the site, improving clinical trial recruitment/engagement and, ultimately, patient care.