Towards standardized quality management for secondary data research

As real-world evidence (RWE) takes on a growing role in regulatory, clinical, and policy decision-making, ensuring the quality of studies using secondary data sources is increasingly critical. In this Peek Behind the Poster, we speak with Dr. Susan Oliveria (Vice President and Global Head of Epidemiology and Scientific Affairs, PPD Observational Studies, Thermo Fisher Scientific) about the ISPE 2025 poster, “Considerations for developing a quality management system: real-world evidence utilizing secondary data.” The discussion explores the rationale for the assessment, methodological insights, and next steps in advancing quality frameworks for RWE.

What prompted this assessment of quality management systems for secondary data studies? Was there a specific gap or challenge in RWE generation that made this work particularly timely or necessary?

There have been a number of regulatory guidances related to the conduct of RWE studies; however, traditional quality management systems (QMS) are often not fit-for-purpose, as they focus primarily on studies involving primary data collection. This prompted us to examine how QMS apply to secondary data studies and to assess whether adaptations are needed.

This assessment combined an ISPE member focus group with a targeted literature search. Why was it important to use both approaches, and how did they complement each other in shaping the findings?

It was important to use both approaches because we first wanted to understand what’s already available in the literature. A targeted search helped understand what has been published in the peer-reviewed literature to give us a sense where potential gaps might lie.

At the same time, the ISPE member focus group brought together stakeholders from academia, the pharmaceutical industry, research organizations, and consultancies – people actively involved in the field with an understanding of how to conduct secondary data studies. It was important to get that barometer of what is happening now versus what is in the published literature.

While there is some overlap between published literature and real-world practice, not everything makes it into publications. So, to get a true sense of what’s happening on the ground in terms of QMS for secondary data studies, it was essential to combine both approaches. They complement each other and provide a more comprehensive perspective.

How did you identify which quality systems from primary data QMS were most relevant to secondary data studies, and what criteria guided your evaluation of their applicability?

After we reviewed the literature, we learned a lot about the relevant components of QMS – sometimes referred to as quality systems within QMS. That allowed us to review what was in existing QMS.

As a stakeholder group, we were then able to go through these different aspects during the focus group and have open discussions about them. Because we’ve worked in secondary data, we understand what’s needed, what might need to be adjusted, and what may be missing altogether. That perspective helped guide how we identified and developed the proposed best practices. These best practices focus on ensuring oversight, maintaining data integrity, and supporting regulatory-grade requirements.

What challenges or limitations did your assessment uncover when applying existing QMS frameworks, such as ICH 6, ICH 8(R1), and ISO9001, to secondary data studies?

It became clear, once we started informally applying these frameworks, that we needed to take a closer look at what existing QMS include, especially in relation to the recommendations coming from governing and regulatory bodies. Importantly, it quickly became evident that what’s currently in place isn’t enough for secondary data studies.

These existing QMS frameworks just don’t fully cover what’s needed, and that was the biggest insight to come out of the discussions.

“For me personally, this highlighted that we have an opportunity here to develop and further refine a quality management system that is better suited to RWE generation and secondary data research.”

Were there any insights from the focus group discussions or literature search that surprised you or challenged your initial assumptions about adapting QMS for secondary data research?

There wasn’t anything that really surprised us. Many, or most, members of the focus group are experienced and knowledgeable ISPE members who have been conducting research for many years. So, while the findings aligned with our expectations, they helped to further solidify our initial hypothesis: that QMS more appropriately adapted to secondary data research are needed.

Looking ahead, what are the next steps in this initiative? Are there plans to expand on these findings through further research, or to pilot adapted QMS frameworks in real-world settings?

The first step is presenting our findings at the 2025 ISPE Annual Meeting. We already have a manuscript in progress, which will be submitted for peer review. This peer feedback will be important, not just for validating our approach, but also for gaining additional support, ideas, and guidance from colleagues to help refine and advance the proposed best practices.

At this stage, we haven’t done any pilot testing as it would be a bit premature. However, this work represents an important starting point.

“The goal is for our work to serve as a first step toward moving the needle on how QMS are developed and applied in secondary data research.”

Interviewee

Dr. Susan A. Oliveria, ScD, MPH, FISPE
Vice President and Global Head of Epidemiology and Scientific Affairs, PPD Observational Studies
Thermo Fisher Scientific

Dr. Oliveria’s career as a pharmacoepidemiologist spans more than 25 years in academia, industry, and non-profit settings. She is trained as a pharmacoepidemiologist, having received her Doctor of Science from the Harvard School of Public Health. In her current role, she leads the scientific teams and activities focused on generating real-world evidence and peri- and post-approval studies to support the value of drugs and devices throughout development and lifecycle management. Before joining Thermo Fisher Scientific, she served as Chief Scientific Officer at Genesis Research, a RWE consulting company. In a prior role as Practice Leader, Epidemiology & Drug Safety, Real World Solutions at IQVIA, she was responsible for leading and accelerating the growth of a global practice that leveraged real-world evidence in regulated use cases and innovative study designs. Previously, she founded the Epidemiology Research Group, was a co-founder of EpiSource, and held several academic positions and appointments at Memorial Sloan-Kettering Cancer Center, Cornell University Medical School, Department of Public Health, and New York Medical College. She is a member of medical and scientific societies, including the International Society for Pharmacoepidemiology's (ISPE's) RWE Collaborative SIG and the Duke-Margolis RWE Collaborative. She is a GetReal Institute Board Member as well as the ISPE liaison, and the ISPE representative for the Duke-Margolis Workgroup: Regulatory Acceptability of RWD/E and Patient-Level Data. Her prior leadership roles for ISPE have included: Industry Board Member, Industry Council Chair, Development Committee Chair, and Finance Committee member.

Acknowledgments

Susan would like to acknowledge the following co-authors who were instrumental in this research:

• Deborah Layton, PEPI Consultancy Ltd. London, UK; Lane Clark & Peacock LLP, Winchester, UK; University of Hertfordshire, Hatfield, UK
• Antonella Porta, Shella Consulting Ltd., Hook, UK
• Dony Patel, IQVIA Ltd., Real-World Solutions, London, UK
• Darmendra Ramcharran, GSK plc, Philadelphia, PA, USA
• Yola Moride, Rutgers Center for Pharmacoepidemiology and Treatment Science, New Brunswick, NJ, USA; YolaRX Consultants, Montréal, Canada
• Asieh Golozar, OHSDI, New York, NY, UAS
• Andrea Splendiani, IQVIA Ltd., Real-World Solutions, London, UK
• Christina Mack, IQVIA Ltd., Real-World Solutions, London, UK
• Sarah Frise, AstraZeneca, Mississauga, Canada
• Doug Kou, Daiichi Sankyo, Wyncote, PA, USA
• Efe Eworuke, IQVIA Ltd., Real-World Solutions, London, UK
• Judit Riera, University Medical Center Utrecht, Utrecht, Netherlands; Universität Autόnoma De Barcelona, Barcelona, Spain

Disclaimer

The opinions expressed in this feature are those of the author and do not necessarily reflect the views of The Evidence Base® or Becaris Publishing Ltd.

Sponsorship for this Peek Behind the Poster was provided by Thermo Fisher Scientific.