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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...

New French Regulations put HCP-Industry Relationships in the Spotlight

by chuck_ltd | 24 Dec, 2015 | CHCUK News & Articles, News, NIS, Pragmatic Trials, Professional Standards, Real Word Evidence, Registry, Virtual Clinical Research

On 17 December 2015, the French National Assembly adopted a law on modernisation of the French health system (the “Public Health Law”).  Key provisions will bring changes to how the pharmaceutical and medical device industries interact with HCPs, by...

NIS Regulatory Compliance – Pains, Problems and Possibilities

by chuck_ltd | 11 Dec, 2015 | CHCUK News & Articles, Data Privacy, News, NIS, Real Word Evidence

Non-interventional studies (NIS) are a key tool for collecting information about how a drug is actually used (+ safety, effectiveness, healthcare benefit and value etc…) once it’s been approved (e.g., by FDA in the USA) and accepted for reimbursement...

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