Inspection Perspective — Tales from a Recent FDA Inspection
The expectations of regulatory inspectors are rising over time - requirements are getting tighter and sponsors are expected to make better use of their systems and data. Our speaker has very relevant experience from hosting an FDA inspection (2019) where this reality was clearly illustrated.
- How this sponsor overcame a rough monitoring and documentation situation.
- What inspectors are seeking about Oversight evidence
- Their thoughts on the processes and systems used for the Trial Master File and the Investigator Study File (ISF)
- Practical steps you can take to protect your study / clinical asset even if things go awry
- Why myClin played a crucial role in "documenting the story of the study" and aiding successful navigation of that inspection.
- Lorne Cheeseman, Senior Director Quality, Various Biopharma
myClin is the leading Clinical Trial Knowledge Platform, offering a transformative collaboration channel and the most documented, data-driven clinical trial oversight.
The company's mission is to leverage technology to enhance participation, engagement, collaboration, and compliance in clinical trials.
The team of clinical research veterans that created myClin in 2008 brought deep experience delivering clinical operations services and building feature-rich eClinical systems. Since then, myClin has been used across all phases of research, in global bio-pharmaceutical and device studies with thousands of clinical users.
myClin is headquartered in Philadelphia, PA, with offices in San Francisco, CA, and the UK.