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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...

Webinar: Pragmatic Studies for Real World Evidence – Lifting the Veils

by chuck_ltd | 24 Feb, 2016 | CHCUK News & Articles, EU Clinical Trials Regulation, HTA, News, NIS, Pragmatic Trials, Real Word Evidence, Webinar

Regulators, Health Technology Assessment (HTA) agencies and health care payers are increasingly demanding Real World Evidence (RWE) to support both initial product approval/reimbursement as well as continuing approval/reimbursement over a product’s life cycle....

What are Pragmatic Clinical Trials?

by chuck_ltd | 22 Nov, 2015 | CHCUK News & Articles, News, Pragmatic Trials

There has been a recent resurgence in the use of the term ‘pragmatic clinical trial’, but what are they? This free report (2015-11-22_Pragmatic-Clinical-Trials_CHCUK#1) summarises the current literature, proposed legislative changes (i.e., the EU Clinical Trials...

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