A structured data ownership model—rooted in ICH GCP principles, supported by MHRA and FDA interpretations, and documented in validated system specifications—will enable sponsors to maintain compliance ...

To inform continued development of the novel immune agent GEN-1, we compared ovarian cancer patients' end points from a neoadjuvant single-arm phase IB study with those of similar historic clinical ...

Please provide your email address to receive an email when new articles are posted on . A comprehensive behavior change intervention aimed at increasing physical activity yielded improvements in ...

Researchers are using analytics and existing patient data to ease recruitment, reduce costs, and accelerate timelines. In association withMedidata Clinical trials have never been more in the public ...

—Using a systematic review of current literature, the World Allergy Organization proposed definitions in CSU for remission and cure and also proposed criteria for therapy step-down. “The step-by-step ...

Over the past few years, we’ve seen a wave of digital innovation in clinical trials: decentralized models, eConsent, real-time monitoring and direct-to-patient logistics. We’ve digitized nearly every ...

Clinical trials are a way to test new methods of diagnosing, treating, or preventing health conditions. The goal is to determine whether something is both safe and effective. A variety of things are ...

Morristown, N.J.-based Atlantic Health serves New Jersey, Pennsylvania and the New York metropolitan area. The not-for-profit health system offers more than 550 sites of care, including eight ...