Rachel Stahler, Chief Information Officer, Syneos Health

CRO Roundup: What’s Happening in the World of Contract Research Organizations

The first quarter of 2018 has witnessed plenty of action in, and insights about, the world of contract research organizations (CROs) providing study-related services to sponsors of drug and device research programs. In late March, word came that a new industry technology standards group had been formed under the guise of Align Clinical CRO. According […]

FDA Headquarters

FDA Clears Up FEI Confusion

A clinical study site network operator recently asked U.S. Food and Drug Administration (FDA) compliance experts for direction regarding FDA Establishment Identification (FEI) numbers. FEI is a unique identifier issued by the agency to track inspections of regulated establishments or facilities. Specifically, the operator asked if all of its study sites can use the same […]

Christina Kahn, CCRP, Senior Director for Site Alliance Management and F1RST Up™ Site Network Manager at Frenova Renal Research

Education Key to Transforming Physicians into Clinical Trial Advocates

A stubborn shortage of principal investigators (PIs) who are willing to manage and conduct clinical trials can be reversed by more effectively educating private practice physicians about their benefits, says Christina Kahn, CCRP, Senior Director for Site Alliance Management and F1RST Up™ Site Network Manager at Frenova Renal Research. She kindly responded to the following […]

Jules Mitchel

Paperless Clinical Trials Gain Momentum

With drug and device manufacturers and the U.S. Food and Drug Administration (FDA) supplying much of the push, so-called paperless clinical trials are gaining momentum in an industry not noted for early adoption of technology, says Jules Mitchel, MBA, PhD, president of Target Health Incorporated. “There are a lot of initiatives from Big Pharma” centered […]

Janet Woodcock

FDA Advances Clinical Study Report Transparency Program

The U.S. Food and Drug Administration (FDA) hopes a new clinical trial summary pilot program will better assess whether focusing on particular aspects of clinical study reports (CSRs) from sponsors will provide additional transparency of agency reviews. The first summary is based on data culled from Janssen’s Erleada (apalutamide), indicated for patients with prostate cancer […]