Regulatory Real-World Evidence Research
Let us help you ensure the safety of your patients by examining and understanding disease indicators and using real-world evidence to support your development and post-approval activities.
To understand disease distribution, risk factors, treatment patterns and impact, comorbidities, burden-of-illness, other related factors, and the effectiveness of risk minimization interventions, or to evaluate safety and effectiveness of medical products, our international and expert team of epidemiologists can help you ask the right questions and apply the right methodologies to yield meaningful and actionable evidence.
Whether you’re looking for consulting advice; database or registry study; prospective observational research; a literature review; or a risk management plan, we can provide you with high-quality, scientifically-rigorous, and publication-ready epidemiology support.
Rely On Our Experts
Our broad range of experience and research collaborations make us an ideal research partner for pharmacoepidemiology studies. Members of our 30+ person team of epidemiologists are often invited as advisors on steering and advisory committees convened by clients, research partners, governments, and academic organizations.
Some of Our Consultative Roles and Experience:
- Dr. Elizabeth Andrews - Co-editor of Mann's Pharmacovigilance
- Dr. Susana Perez-Gutthann - Co-Chair, Steering Committee of the European Network of Centre for Pharmacoepidemiology and Pharmacovigilance (ENCePP); Board Chair and Executive Committee of the SIGMA Consortium
- Dr. Alejandro Arana - Co-Chair of the Research Standards Working Group of the ENCePP
- Dr. Kenneth Rothman - Editor and co-author of Modern Epidemiology, and Epidemiology: An Introduction. Developer of Episheet
- International Society for Pharmacoepidemiology leadership roles include two past Presidents, eight past members of the Board of Directors, three past ICPE program chairs, Fellows, and chairs of various committees and special interest groups
Resources from our experts:
Co-edited by Elizabeth Andrews, Mann's Pharmacovigilance provides a definitive drug safety resource for pharmaceutical researchers and students.
Authored by Kenneth Rothman, Epidemiology: An Introduction, remains one of the most quoted epidemiology methods books since the late 1990s.