If Robert Califf’s nomination to helm the FDA a second time succeeds in Congress, he is likely to push for clinical research reforms, with a focus on diversity, the increased use of real-world evidence (RWE) and addressing the rising costs and complexity of trials. Read More
Industry is approaching a watershed moment, with sponsors and CROs planning for the first time to conduct more hybrid trials than traditional site-based trials, a trend that is expected to play out across all trial phases and therapeutic areas. Read More
Emmes and MedGenome have announced a strategic partnership aimed at accelerating the delivery of breakthrough rare disease treatments through the use of genomics data. Read More
Sponsors that plan to use registry data or create a registry to support a clinical trial should be prepared to consult with the FDA on their plan’s effectiveness. Read More
The FDA is putting new emphasis on its collaboration with multiple international regulators to bolster oversight of GCP and data integrity in clinical trials. Read More
