| | | | [Webinar]Maintaining Momentum: Applying Recent Regulatory Guidance in the Midst of the Coronavirus |
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Date: Thursday, April 30, 2020
Time: 10am EST / 7am PST
Duration: 1 Hour |
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The importance of clinical research is in the forefront around the world with COVID-19 as companies race to develop vaccines and antivirals to address the disease. Regulatory agency guidance has presented the industry with a unique opportunity to shift the direction of research to address the myriad of diseases that still need treatments and cures. With protection of health care professionals and clinical trial subjects being paramount, the process and procedures of how we conduct successful clinical trials going forward must be immediately addressed – and for studies currently underway it is even more critical.
The emerging questions are “What is the regulatory guidance regarding how we should proceed with current and proposed clinical studies” and more importantly “Do we have the technology to do so” to keep studies on track and maintain our timelines. We say, ‘yes’!
Regulatory agencies have begun to issue their initial guidance on operational issues regarding clinical trial conduct and how sponsors can maintain the momentum of their ongoing studies.
A panel of CATO SMS experts will review the key issues contained in the emerging Agency Guidance and offer thoughts on what changes and options for sponsors may be seen in the coming months. |
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| CATO SMS is a full-service clinical and regulatory contract research organization (CRO), specializing in complex areas such as (immuno-) oncology, advanced therapeutics and orphan diseases. We offer regulatory consulting and drug development affairs in addition to clinical trial management services, leveraging the experience and expertise in all disciplines to the full benefit of your company. We are committed to supporting small and mid-sized biotech, top-tier pharmaceutical companies and investigator groups from strategy to approval, from phase I to IV. CATO SMS employs over 320 dedicated professionals with offices and operations in over 25 countries around the globe including the United States (US), Canada, Europe, Israel and South Africa. Offices are strategically located close to the European Medicines Agency (EMA) in Amsterdam, the Netherlands, and the Food and Drug Administration (FDA) in Washington, US. |
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