Post-Authorization Studies

Evidence That Endures Beyond Approval

Approval is just the beginning. As regulatory agencies increasingly require post-authorization studies to monitor long-term safety, confirm efficacy, and support risk management, pharmaceutical and biotech companies must be prepared to generate real-world evidence (RWE) that meets the highest scientific and regulatory standards.

Our team of experts can help you design and execute Post-Authorization Safety Studies (PASS) and Post-Authorization Efficacy Studies (PAES) that deliver meaningful insights, fulfill regulatory obligations, and support product lifecycle management.

How We Can Help You

We offer full-service support for post-authorization research, including:

  • Study Design & Protocol Development - Tailored to meet FDA and EMA expectations.
  • Data Source Identification & Access - Leverage global electronic health records, claims databases, and disease registries.
  • Regulatory Strategy & Submission Support - Align with EMA’s PAES guidance and FDA’s PAS protocols.
  • Advanced Analytics & Reporting - Apply causal inference, propensity score matching, and longitudinal modeling to ensure robust findings.
  • Stakeholder Engagement - Collaborate with regulators, scientific advisory boards, and patient communities to ensure transparency and relevance.
On top of their very valuable network of EU data providers and strong expertise in the RWE ecosystem, the team is highly skilled and consistently demonstrates an ability to tailor language and communication to align with the specific needs of each project.
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PASS feasibility study

Featured Publications

Ahmadizar F, Cid Royo A, Ryan O, Plana E, Arnau JR, Tarazjani AD, Mohammadi S, Garcia-Esteban R, Pajouheshnia R, Boric K, Pala E, Brutau A, Haugh M, Martinez JJC, Urchueguia A, Martinez EC, Herrero-Silvestre M, Lysen T, Overbeek J, Gaspersz J, Villalobos F, Bissacco CA, Williams C, Praet N, Sturkenboom MCJ, Fortuny J. Evaluating the safety profile of the Janssen COVID-19 vaccine (JCOVDEN): a VAC4EU post-authorization safety study. Presented at the 2025 International Society for Pharmacoepidemiology (ISPE) Annual Meeting; August 26, 2025. Washington, DC.

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