Safety & epidemiology research
Real world insights for regulators
We provide advantages in the race to develop real-world insights and respond to regulatory requirements. With scientific guidance and integrated data, our teams help bring clarity and confidence to complex processes amidst expedited regulatory timelines.
Key strengths
Maternal health research
Pregnant women and infants are often excluded from clinical trials and are underrepresented in research. Our team uses data on millions of babies born in the U.S. and comprehensive pregnancy related algorithms in linked moms and infants to better understand drug safety for this special population. We’re actively involved in high-impact pregnancy-related studies with life sciences and government agencies.
Drug/vaccine safety and effectiveness
Real world post-market research on drug and vaccine safety and effectiveness is essential for informed decision making. We design and implement complex epidemiologic studies aiming to assess drug/vaccine safety and effectiveness for millions of people. Our epidemiologists and biostatisticians use innovative methods to provide robust insights in response to regulatory requirements.
Regulatory experience
In collaboration with life science partners, we design, manage, and implement FDA and EMA required post-market requirement (PMR) and post-authorization safety studies (PASS) for single and multi-database studies.
Advanced algorithm development and validation
Quality data is critical for quality study results. When health conditions are difficult to classify in administrative data, we develop and validate claims algorithms to deliver stronger studies with more reliable and less biased results. We link claims data to medical records, cancer registries, the National Death Index, and other sources, and use machine learning methods to identify difficult-to-classify health conditions of interest with greater accuracy to improve the quality of our research.
Oncology research
Improving our understanding is essential for diminishing the tolls of cancer. We help clients generate faster and more robust insights with our data, which includes integrated claims, oncology clinical data, mortality data, and lab results. We develop algorithms to help understand the natural history, treatment landscape, and safety of targeted therapies within specific groups of people. These and other advanced research methods combined with years of experience enable us to design, conduct, and analyze complex data — making challenging questions easier to answer.
Safety & epidemiology research features
Pre-approval
- Characterize and quantify indication: cases, comorbidities, therapies, and adverse events
- Drug utilization studies
- Natural history studies
Post-approval
- Post-authorization safety studies (PASS/PMR)
- Scientific & Data Coordinating Center designing, managing, and implementing multiple database studies
- Risk Evaluation and Mitigation Strategies (REMS) assessments using patient and provider surveys
Validation
- Develop and validate algorithms using diagnostic models involving machine learning
- Validate claims against a gold standard by linking patients to medical records, clinical data, and external registries
