Good Clinical Practice

EMA: GCP deviations increasing

EMA: GCP deviations increasing

By Melissa Fassbender

The EMA recently updated its Good Clinical Practice (GCP) Q&A to address several contractual arrangement “pitfalls” – specifically with electronic systems vendors.

TransCelerate CEO, leaders offer update on industry group’s activities

Dispatches from PCT US

TransCelerate CEO, leaders offer update on industry group’s activities

By Zachary Brennan

As 20 of the largest biopharma companies have now joined industry group TransCelerate, the group is beginning to use patient centricity and connectivity to influence the clinical trial environment, CEO Dalvir Gill told attendees at the Partnerships in...

FDA looks to cut back on the waste from having to start trials from scratch

US FDA working to make clinical trials less wasteful

By Zachary Brennan

The US FDA is looking to set up master protocols that can continuously run and help cut down on waste that’s prevalent in the clinical trial industry, Director of FDA's Center for Drug Evaluation and Research Janet Woodcock said in an interview.

French regulator raises concerns over Indian CRO studies

French regulator raises concerns over Indian CRO studies

By Zachary Brennan

Concerns over India-based GVK Biosciences have been raised in a letter from France’s ANSM (Agency for Medicines and Health Products Safety) to marketing authorization holders following a GCP (good clinical practice) inspection citing deficiencies in the...

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