The FDA’s Office of Good Clinical Practice responds to inquiries on a variety of trial-related subjects, providing answers on the agency’s official regulations as well as best practices. The following is a selection of questions and answers excerpted from the CenterWatch publication GCP Questions, FDA Answers. Read More

FDA inspections have been heavily focused on sponsor, CRO and site outsourcing activities since the Bioresearch Monitoring (BIMO) Program revised its manual for inspection processes in September 2021. Read More

As more and more trials opt to include electronic patient reported outcomes (ePRO), sponsors must consider whether they will provision devices or use a bring-your-own-device (BYOD) model. In some cases, they may choose a hybrid option that allows some participants to use BYOD and others to receive provisioned devices. In a recent blog post for WCG Insights, Jan Sedway, vice president of clinical science for WCG VeraSci, lays out key factors to consider when deciding on an approach for ePRO. Read More

With clinical research professionals exiting the industry in droves, it’s high time for research institutions to step back and assess themselves internally, evaluating how their own paradigms, cultures and priorities affect employees. Read More