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  • COVID-19 has had a significant impact on the conduct and planned analysis of ongoing trials not to mention the design of new studies. Time CRAs can spend at sites will be limited. Performing remote site visits via "Zoom" like tools is an option. Remote ...

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  • The U.S. Food and Drug Administration issued an updated guidance, "Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic," with an appendix adding questions and answers on this subject. We plan to update this appendix as new questions ...

  • In Nov 2019 an important ICH guidance came out that impacts the design, conduct, analysis and reporting of clinical trials. Please take the 2 Minute Survey at link: https://www.surveymonkey.com/r/ICHGuidance-CTs ------------------------------ Munish ...

  • The EMA management board endorsed  to  commence the system audit of the Clinical Trial Information System (CTIS) in December 2020. This will start the clock when the new EU Clinical Trial Regulation will finally be implemented,  vastly changing how clinical ...

  • I am a doctoral candidate at USC and I am conducting an academic research study of industry views on the implementation of decentralized clinical trials for my thesis. This study will evaluate how, why and at what rate decentralized clinical trials ...

  • Are you a medical /safety professional who works in a smaller-sized company where you may have less resources but you need to review your safety data? Are you a medical/safety professional where you wish you could change the endless listings into an ...

  • Dear all,   Are you a medical /safety professional who works in a smaller-sized company where you may have less resources but still you need to review your safety data all the time?   Are you a medical/safety professional where you wish ...

  • Hi Dylan and Anyone interested in the topic, You are invited to a Zoom webinar. When: Dec 4, 2019 12:00 PM Eastern Time (US and Canada) Topic: GDPR and Patient Personal Information Compliance in Clinical Studies Register in advance for this webinar: ...

  • ​ 4th DIA Cell and Gene Therapy Products Symposium in Japan - Development and Practical Use of Cell and Gene Therapy Products in Japan and Across the Globe - December 16-17, 2019 Day 1: New Challenges in Global Development Day 2: Reality ...

  • There is no question about the need to have different regulatory approval expectations for agents that treat rare diseases. However, this is a complex issue and I would suggest that the issue needs to consider not just the FDA evidence requirements but ...

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