Due to evolving practices and increased regulatory attention on expert committee operations, sponsors are t...
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Something Has to Give: The Current Unsustainable Approach to Safety Reporting Puts Trials and Patients at Risk
WCG MedAvante-ProPhase espouses a rather simple philosophy: minimize variability, generate cleaner data.
How can a site move up the selection list and participate in these trials? It’s as simple as one word: metrics.
Learn what high-performing research sites have in common, and what makes sponsors return to them again and again.
Small and emerging biopharmas are conducting almost 50% of clinical trials in the U.S., often with lean teams, resources and infrastructure. Learn how to reduce the pressure on teams and timelines.
Some deviations from the IRB approved protocol are planned while others are unintentional or unplanned. The FDA and HHS (45 CFR §46.103(b)(4) and 21 CFR §56.108(a)(4)), position is that...
The local newspaper is planning to run a story on a new clinical trial that will highlight the development of an exciting new drug and the work done by our principal investigator...
As a sponsor, what do the regulations say about paying research subjects? What are acceptable practices for compensating subjects for participating in a clinical trial?
What’s the role of expert committees today? What’s happening on the regulatory side? Dr. Seltzer, Chief Scientific Officer of WCG Clinical, shared his insights on expert committees during a recent...
Learn how to engage sites more effectively with the appropriate recruitment resources, use dedicated staff to manage recruitment efforts, and eliminate bottlenecks and expedite recruitment timelines.
Roche recognized several major challenges that its CTSP 2.0 system needed to address.
Dissatisfied with its electronic IRB research management solution, OhioHealth Research & Innovation Institute searched for a solution to improve compliance, efficiency, customer service, and cost.
The impact of participant payments on clinical trial recruitment.