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 ...

The use of RWD data in place of placebo groups is improving various elements across the clinical trial space. Clinical trials are possibly the most vital access of the drug development process, and ...

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 ...

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 ...

This Journal feature begins with a case vignette highlighting a common clinical problem. Evidence supporting various strategies is then presented, followed by a review of formal guidelines, when they ...

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 ...

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 ...

CHICAGO – The principal lab for a nationwide coronavirus testing company under investigation by several states is now the focus of a federal agency probing allegations of misconduct at the site. The ...

—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 ...