Consultant Observational Studies

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

Non interventional studies have to comply with good epidemiology GEP and pharmacovigilance GVP practises as defined by EU PV Module VIII on PASS. 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 form an important 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 compleeted studies worldwide is requird reported via DSURs/PSURs, riskmanagement plans and must be included in the Master File.

Contact DSC here