For the first time ever, the FDA has threatened enforcement and fines against a sponsor for failing to submit trial results to ClinicalTrials.gov by required deadlines. Read More

As clinical trial professionals prepare for postpandemic operations, they see technology adoptions and hybrid protocol designs as the innovations most likely to be continued after the crisis ends. Read More

After a two-year collaboration, two industry nonprofits have unveiled an approach for safety reporting that will help sites reduce the amount of duplicate adverse event (AE) data entry they currently do to meet sponsor and regulatory requirements. Read More

A clear focus on hybrid solutions and customization to a site’s needs will be the hallmarks of clinical trials postpandemic, along with a strengthened ability to shorten trial timelines. Read More