Antidote Amos Ndhere MD, MS

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

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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...

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#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

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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!




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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 reasonable costs while adhering to safety standards.



Get Your FREE Regulatory FAQ To Build A Robust Regulatory Strategy:

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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



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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: 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



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PS - Join the conversation on social!



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Conducting vaccine and drug clinical trials 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 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


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