Few sponsor responsibilities carry more regulatory and participant-safety implications than determining whether an adverse event requires FDA expedited IND safety reporting. Making the right reporting decision is not always straightforward. Sponsors must evaluate whether an event is serious, whether it is reasonably associated with the investigational product, and whether it is considered unexpected based on...Read More

A rare disease, as defined by the FDA under the Orphan Drug Act, affects fewer than 200,000 people in the United States. Globally, estimates suggest more than 7,000 rare diseases have been identified, many of them serious, debilitating, genetic, and life-threatening. While each condition impacts a relatively small population, the collective burden is significant. For...Read More

Protocol complexity in clinical trials is increasing and it’s becoming a major barrier to study success. More procedures, more endpoints, and more data may strengthen a study on paper. But in practice, they can slow enrollment, strain sites, and make participation harder for patients. For sponsors and clinical operations teams, the challenge is no longer...Read More

As decentralized and hybrid clinical trial models mature, sponsors and CROs are increasingly adopting digital approaches to informed consent. Yet in regulatory inspections and sponsor oversight activities, we continue to see a persistent — and potentially risky — conflation of two related but distinct concepts: eConsent and remote consent. Understanding the difference is not merely...Read More

Clinical trial start-up is one of the most underestimated phases of drug development, and one of the most consequential. In fact, a study’s success is often determined long before the first patient is enrolled. For complex studies, particularly global Phase 3 programs, the start-up period is where strategic planning, operational discipline, and tight cross-functional collaboration...Read More

Decentralized Clinical Trials (DCTs) represent a paradigm shift from traditional clinical trial models. Unlike conventional clinical research trials, which require participants to visit research or medical centers, DCTs leverage digital health technologies, such as telehealth visits and/or home health visits to conduct trials remotely. This approach not only enhances participant convenience, making clinical trials more...Read More