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Regulators, Industry Debate Meaning of Real-World Evidence in Trials

There’s no shortage of buzzwords in the clinical trial industry. Patient centricity and virtual trials have been flavors of the month for some time now, for example. But for pure staying power, real-world evidence (RWE) has a pretty impressive track record, too. Unfortunately, as evidenced by a slew of recent comment letters, regulators and industry […]

Clinical Trial Practitioners Extol Virtues of Training, Certification

Adequately trained monitors/clinical research associates (CRAs) “will be prepared for just about anything” an increasingly complex clinical trial landscape is liable to throw at them, says Maggie Potrikus, BSN, CCRC, MBA, a quality assurance and compliance manager with Concentrics Research, a contract research organization (CRO), and former contracted CRA to Roche Diagnostics. On the other […]

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FDA Guidance Offers Important REMS Definitions

A new guidance from the U.S. Food and Drug Administration (FDA) provides the agency’s latest thinking on how it defines the types of changes to approved risk evaluation and mitigation strategies (REMS) for the monitoring of medications with a high potential for serious adverse effects, how application holders should submit changes to an approved […]

Study: Credentialed Principal Investigators and CRCs Perform Better

The research is clear: certified principal investigators (CPIs) and clinical research coordinators (CRCs) do better work compared with their peers who hold no certification. Much better work, in fact. That was the thrust of the DIA session Assessing the Impact of Credentialing on Clinical Trial Quality and Performance. It was led by Ken Getz, director […]