Pivotal Clinical Trial Podcast: Recent Episodes
Dr. Amos Ndhere MD,MS
The Pivotal Clinical Trial podcast, host Dr. Amos Ndhere, accompanied by pharmaceutical industry leaders, scientists, global health and medical experts at the forefront of combating infectious disease and emerging pathogens reveals the latest cutting-edge medical innovations, industry insights, tips, and tools to deliver life-changing treatments to patients faster and more efficiently. Weekly’s newest episodes break down strategies, end-to-end clinical operations, and "How-To's" of safely delivering the vaccine, biologic, and device clinical research in a constantly changing world.
International Conference on Harmonization (ICH) Good Clinical Practice (E-6) requires investigators and sponsors to retain specific study records associated with the conduct of clinical research. These documents are often referred to as Essential Documents. 🎥 In this video, I share insights about clinical research record retention in the context of global health trials. The practices, essentially follows International Conference on Harmonization-ICH GCP Guidelines E-6 section 8**Hi, I am Dr. Amos Ndhere, a medical doctor, vaccinologist and pharmaceutical product development specialist.I help pharma💊 industry leaders accelerate safe 🛡️ & cost-effective clinical trials that deliver life-saving treatments to patients faster 🚀, increase revenue 💰, and expand emerging market share📈Hey there! Are you interested in discussing efficient and safe ways to deliver your next global health research? Let's have a chat and explore your options!https://www.aceresearchafrica.com/con...****PS - Join the conversation on social!https://www.linkedin.com/in/amosndherehttps://twitter.com/amosndherehttps://facebook.com/amosndherehttps://www.instagram.com/amos.ndhere/Clinical Research #clinicalresearch #clinicaltrials #Africa #publichealth #gcp
Clinical trials play a crucial role in developing new medical treatments and vaccines. They are the stepping stones that bring hope to patients. Regulatory delays have significant consequences for the pharmaceutical industry and patients and their families who rely on timely R&D of new treatments for better outcomes and quality of life.
In this video, I will explain the consequences and impact of clinical research regulatory delays.
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Hi, I'm Dr. Amos Ndhere! I am a medical doctor, Clinical Investigator, and Regulatory affairs specialist.
My goal is simple: Reduce the pain of clinical research and help biopharma industry leaders get new treatments to market faster, at a reasonable cost, while adhering to safety concerns.
Do you want to deliver your clinical trial in Africa safely?
Let's talk*PS - Join the conversation on social!
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Twitter
YouTube
As a pharmaceutical sponsor of clinical research, you want a seamless, efficient, and prompt regulatory submission, review, and approval for your next clinical trial. The challenge lies in the fact that the regulatory process may have its own pace.
But what if you strategically aligned your team's objectives with the regulatory agency's course to accelerate clinical trial regulatory approval for your next vaccine or drug trial?
In this video, I will explain 7 simple strategies pharmaceutical sponsor teams can take to achieve their timeline objective and overcome regulatory obstacles.Listen now!
Hi, I'm Dr. Amos Ndhere! I am a medical doctor, Clinical Investigator, and Regulatory affairs specialist.My goal is simple: Reduce the pain of clinical research and help biopharma industry leaders get new treatments to market faster at reasonable costs while adhering to safety standards.
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This two-part episode reveals 12 common non-sponsor-related causes and reasons for clinical regulatory delays and offers expert insights and guidance on navigating them. Understanding these causes helps Sponsor teams to:
- Plan Regulatory Submission,
- Make informed GO/No-Go Decisions,
- Mitigate Risks, and
- Hedge Clinical Development Plan.
Listen now!
Hi, I'm Dr. Amos Ndhere! I am a medical doctor, Clinical Investigator, and Regulatory affairs specialist.
My goal is simple: Reduce the pain of clinical research and help biopharma industry leaders get new treatments to market faster at reasonable costs while adhering to safety standards.
Do you want to deliver your next clinical trial in Africa safely?
Let's talk
PS - Join the conversation on social!
LinkedIn
Twitter
YouTube
The R&D window during an outbreak is very short; in some cases, there is only a limited number of patients for experimental treatment.
Pharmaceutical sponsors will struggle to complete the R&D of vaccines and treatments against global health biothreats in outbreak settings until they leverage lessons learned and decisive actions to overcome practical difficulties of R&D in an outbreak setting. In this part-2 episode, I’ll explain additional key factors that led to R&D successes during the 2014-15 Ebola virus outbreak in West Africa. If you haven’t watched the part-1 video, I’ve included the link in the description below.
Watch PART 1 Video Now*Hi, I'm Dr. Amos Ndhere! I am a medical doctor, Clinical Investigator, and Regulatory Affairs Specialist.
My goal is simple: Help Pharma industry leaders understand key trends, top strategies, and tools to conduct R&D in emerging markets and deliver life-changing treatments to patients faster. Do you want to deliver your clinical trial in sub-Saharan Africa safely?
Let's talk
*PS - Join the conversation on social!
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YouTube
Conducting vaccine, drug, and biologics R&D during disease outbreaks can be a drag. Sponsors will struggle to deliver new products against global health biothreats unless they leverage lessons learned during previous studies to influence clinical research development plans during future outbreaks.
In this Episode #03, I will explain how lessons learned during the 2014-15 West Africa Ebola virus outbreak can supercharge R&D during future outbreaks and deliver life-saving clinical products to patients and families faster.
Hi, I'm Dr. Amos Ndhere! I am a medical doctor, Clinical Investigator, and Regulatory Affairs Specialist.
My goal is simple: Help Pharma industry leaders to gain a sound understanding of key trends, top strategies, and tools to conduct R&D in emerging markets and deliver life-changing treatments to patients faster.
Do you want to safely deliver your clinical trial in sub-Saharan Africa? Let's talk: https://lnkd.in/g_H5UfqD...
Please like, share and give me a 5-star, that'd be appreciated!
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Regulatory authorities in Sub-Saharan Africa are scrutinizing pharmaceutical companies’ risk management and control practices with more rigor than ever before. Choosing the right insurance for human clinical trials can be a drag, especially in sub-Saharan Africa. Clinical trial sponsors must procure appropriate insurance coverage which must fulfill country-specific statutory requirements and provide adequate risk management and control during the life of a clinical trial.
In this episode, I will discuss the following:
- What is Clinical trial insurance?
- Forms of insurance policies
- Types of insurance covers required in Sub-Saharan Africa
- Who should be indemnified?
- Risks covered under Insurance
- Policy limit requirements
- Term of Insurance policy
Hi, I'm Dr. Amos Ndhere! I am a Medical doctor, Clinical Investigator, and Regulatory affairs specialist.
My goal is simple: Help YOU with the right tools, tips, and framework to deliver life-changing treatments to patients faster through clinical research and emerging market access.
Do you want to safely deliver your clinical trial in sub-Saharan Africa?
Let's talk: https://www.linkedin.com/in/amosndhere
Please subscribe, that'd be appreciated! 👍🏻 👏 ❤️ ✍
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Africa's pharmaceutical market is $60B and CAGR is about 10%. Global pharmaceutical companies will struggle to break into the growing African market until they position pharmaceutical products correctly. In this video, I will explain how Medical Affairs can position products for the growing African market and WIN a piece of the $60B market share.
Hi, I'm Dr. Amos Ndhere! I am a medical doctor, Clinical Investigator, and Regulatory affairs specialist.
My goal is simple: Help YOU with the right tools, tips, and framework to deliver life-changing treatments to patients faster through clinical research and emerging market access.
Do you want to safely deliver your clinical trial in sub-Saharan Africa?
Let's talk: https://www.aceresearchafrica.com/con...
Please subscribe, that'd be appreciated!
👍🏻 👏 ❤️ ✍
PS - Join the conversation on social!
https://www.linkedin.com/in/amosndhere
https://twitter.com/amosndhere
https://facebook.com/amosndhere
Did you know more clinical studies happen in Africa compared to South Asia and Australia? In this two-part podcast series, Dr. Amos Ndhere offers insights on the evolution of the clinical research landscape, drivers, key opportunities and benefits, and how pharmaceutical industry can maximize R&D ROI in Africa.
You can also download a FREE report using this link. https://lnkd.in/ecaMvj-V
Africa is one of the fastest-growing and emerging pharmaceutical markets. The African pharmaceutical industry is experiencing 9-12% CARG. In this episode, host Dr. Amos Ndhere shares insights and strategies to help industry leaders to win the growing $60B market share. Specifically, we uncover:
How to position final pharmaceutical products such as vaccines, drugs, and medical devices for the African market Who are the key stakeholders in Africa? Actionable strategies for medical affairs leaders And SO much more...
Links from the Show