Increasingly, payers and physicians are seeking real-world data on newly approved medications. Post-Authorisation Safety Studies (PASS) can provide this vital safety information and encourage market acceptance and uptake.
post-authorisation safety study
This year Partnerships in Clinical Trials Europe is bringing together clinical development outsourcing professionals to discuss “The era of change: A panoramic vision of reform, challenge and innovation in clinical trials.” With services that span Clinical Development, Late Stage Research and Safety, UBC is uniquely positioned to add our voice to the conversation.
A recent report from the Pharmacovigilance and Risk Assessment Committee (PRAC) found that in the 200+ study protocols reviewed, nearly half suffered from study design flaws. Don’t let methodological issues stall approval of your next Post-Authorisation Safety Study (PASS).