Consultant Observational Studies

Drug Safety Consult offers auditing and QA consultancy in non-interventional PASS studies and similar activities intended for the surveillance of product safety.

Non interventional studies have to comply with good epidemiology GEP and pharmacovigilance GVP practices as defined by EMA Module VIII and relevant guidance documents and rules. When done up to the required scientific standards, these observational studies provide crucial information on the "real life" use of a product and are essential tools for safety risk management.

Observational Studies is an important source for solicited reports and an element of pharmacovigilance planning and risk management and are often requested by regulatory authorities as part of granting a marketing authorisation. Status on ongoing and completed studies is required reported via PSURs, DSURs and Risk Management Plans and are within EU under the control of the EU PRAC.

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