PASS

A Panoramic View of Market Authorisation in the EU

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.

English

Four Key Considerations for Long-Term Patient Registry Design

One of the biggest operational challenges with the design of registries, also called post-approval safety studies (PASS), is understanding the differences with clinical trials. Clinical trials involve subjects with very specific inclusion/exclusion criteria and protocol procedures, but registries take “all comers” with limited inclusion/exclusion criteria seen as part of routine care. Often sponsors design what they believe is a registry but is actually a post-approval study based upon clinical trial guidelines and SOPs.

English
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