Patients have spoken: Flexibility, including the option of in-person visits, is still vital to their willingness to take part in trials even after the pandemic made remote and virtual approaches the norm, a global survey has found. Read More
This is the second in a four-part CenterWatch Weekly series on the principles and best practices of setting investigator compensation levels that are both fair and compliant with federal laws. This week, we look at various methodologies for determining compensation. Read More
The FDA has acknowledged the challenges sponsors face in standardizing study data taken from real-world data (RWD) sources and issued draft guidance to help sponsors make adjustments. Read More
The FDA has published a letter to industry reminding sponsors that IRBs must review all diagnostic device trials involving human participants, even ones that use leftover, de-identified human specimens. Read More
The European Commission (EC) has issued an updated Q&A outlining what information sponsors should provide in the protocol synopses they must submit with their clinical trial applications under the upcoming Clinical Trials Regulation (CTR) set for launch in January 2022. Read More
