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A large-scale shift toward using electronic consent in clinical trials — rather than older, clunkier paper versions — could improve understanding of the process, speed up enrollment and enhance trial monitoring, but sponsors and sites must be willing to adapt to the changes, an expert says. Read More
As centralized risk-based clinical trial monitoring becomes the norm, sponsors are gaining access to broad overview data on research and compliance trends that can help them identify both real and potential problems across their trial locations. Read More
The House Energy & Commerce Committee is once again demanding information on the status of all patients in NIH clinical trials affected by the shutdown of the agency’s drug compounding facility, despite receiving a letter from NIH saying there were no negative impacts on affected patients. Read More
President Obama’s nomination of Robert Califf to lead the FDA is drawing praise from those in industry and academia who see him as an outstanding choice and a strong leader deeply respected by the scientific community. Read More
The FDA is clarifying when drugmakers can seek dispute resolution above the divisional level, citing five regulatory actions that are appropriate for a formal dispute resolution request. Read More
The European Medicines Agency is seeking feedback on the International Conference on Harmonization’s revised E6 guideline, which adds new recommendations for sponsors on developing risk-based quality management systems for clinical trials. Read More
Clinical trial patients are beginning to review their study sites on social media forums like Yelp, and one expert says sites should start thinking about how to manage their online reputations. Read More
The primary efficacy endpoint in clinical trials for uncomplicated gonorrhea should be a negative culture at the infection site three to seven days after receiving antibacterial drug therapy, the FDA says. Read More