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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.

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.

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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.

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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:

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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.

Let's talk

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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.

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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.

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Conducting R&D during disease outbreaks can be a drag. Global pharmaceutical companies will struggle to deliver new vaccines, drugs, and diagnostics against global health biothreats unless they leverage lessons learned and key success factors during previous studies to guide clinical research development plans during subsequent outbreaks.   

In this video, I will explain how lessons learned during the 2014-15 West Africa Ebola virus outbreak can supercharge R&D during future outbreaks and help deliver life-saving clinical products to patients and families faster.   

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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 YOU with the right tools, tips, and framework to deliver life-changing treatments to patients faster through clinical research and emerging market access.

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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 difficult, especially in sub-Saharan Africa.

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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.

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.

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