Registry-enabled pharmacovigilance: Building fit-for-purpose PASS through scientific partnerships
As regulatory expectations for long-term safety evidence continue to evolve, sponsors increasingly need to match the right evidence source to the right regulatory question. Building on research presented at the 42nd ISPE Annual Meeting, this Deep Dive draws on insights from Melissa Moore-Clingenpeel, Director of Biostatistics, Prospective Real-World Studies (Thermo Fisher Scientific), to explore how independent prospective registries complement secondary-use RWE and why scientific governance and scientific partnerships are becoming increasingly important for delivering fit-for-purpose post-authorization safety studies (PASS).
Key learnings from the discussion:
- Why claims and EHR data cannot always capture long-latency events, evolving disease activity, or complete treatment histories
- How matching the evidence source to the regulatory question matters more than defaulting to whatever data is most convenient
- What scientific governance looks like in practice, from protocol-driven data collection to active surveillance at every registry visit
- Why involving registry scientists and pharmacovigilance experts early reduces costly surprises later in a study
- How registries adapt mid-study when new safety signals emerge, without losing methodological consistency
For professionals working in HEOR, RWE, pharmacovigilance, regulatory affairs and market access, this Deep Dive explores how independent registries and scientific partnerships are helping to shape the future of fit-for-purpose PASS.
Read the full Deep Dive for the complete conversation with Melissa Moore-Clingenpeel.
About the researcher
Melissa Moore-Clingenpeel, MA, MS (she/her/hers)
Director of Biostatistics, PPD CorEvitas Clinical Registries, Thermo Fisher Scientific
Melissa Moore-Clingenpeel is Director of Biostatistics for Pharmacovigilance within the PPD CorEvitas Clinical Registries team at Thermo Fisher Scientific. She has more than 15 years of experience in real-world evidence generation, with expertise in longitudinal study design, causal inference, and the analysis of healthcare data. Her work focuses on the design and statistical oversight of observational studies supporting drug safety, effectiveness, and regulatory decision-making. Throughout her career, she has collaborated with multidisciplinary teams across academia, industry, and healthcare organizations to develop and apply rigorous epidemiologic and biostatistical methods to real-world data. Her research interests include causal methods, comparative safety and effectiveness research, and innovative approaches to pharmacovigilance using real-world data.
Acknowledgments
Melissa Moore-Clingenpeel would like to acknowledge her Thermo Fisher Scientific co-authors Christine Barr, Gaby Tayeh, Jeff Greenberg, Dimitrios A. Pappas, Peter M. Wahl, and Heather J. Litman. The work discussed in this Deep Dive was presented at the 42nd International Society for Pharmacoepidemiology (ISPE) Annual Meeting 2026 in the poster, "Advancing Fit-for-purpose Post-Authorization Safety Evidence Generation Through Registry-Based Pharmacovigilance (PV) and Scientific Partnership."
Disclaimers
The opinions expressed in this feature are those of the researcher and do not necessarily reflect the views of The Evidence Base® or Becaris Publishing Ltd.
Sponsorship for this Deep Dive was provided by Thermo Fisher.