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New FDA Guidance on Informed Consent Waiver for Clinical Investigations Involving No More than Minimal Risk

by chuck_ltd | 27 Jul, 2017 | 21 Century Cures Act, CHCUK News & Articles, Pragmatic Trials, Real Word Evidence

FDA issues guidance for immediate implementation- IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects Author: Patricia Garcia, Regulatory Consultant, Late Stage, Clinical Division, Inventiv...

Survey – Pragmatic Clinical Trials

by chuck_ltd | 3 Apr, 2017 | 21 Century Cures Act, Cures Act, EU Clinical Trials Regulation, Pragmatic Trials

It’s been 50 years since Schwartz and Lellouch(1) first introduced the concept of pragmatic clinical trials (PCTs) and now major changes in the EU(2) and USA(3) regulations have made the conduct of these PCTs more favourable, but who, if anyone, is conducting...

The RWE Equation: Finding the Right Late-Stage Study Design

by chuck_ltd | 10 Sep, 2016 | CHCUK News & Articles, News, NIS, Pragmatic Trials, Real Word Evidence, Registry, White Paper

White Paper – The Real-World Evidence Equation: Finding the Right Late-Stage Study Design Florian Eichmann, PhD, Principal, Scientific Affairs & Real World Evidence, Late Stage, inVentiv Health Clinical Stuart McCully, PhD, Vice President, Regulatory...

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