Specialized Pharmacoepidemiology Consulting
Plug in the scientific expertise you need to successfully meet your post-marketing requirements
Plug in the scientific expertise you need to successfully meet your post-marketing requirements
With 13+ years of experience in the industry, we provide expert services in FDA-mandated Risk Evaluation and Mitigation Strategy (REMS) programs and observational pregnancy safety studies. We offer efficient and high-quality support in program/study design, protocol/SAP development, analysis, evaluation, reporting, scientific oversight, and FDA inspection readiness.
Based on your product's benefit-risk profile, we'll work with you to:
Once your REMS is up and running, we'll ensure your company is ready for an FDA inspection.
We’ll work with you to develop or modify your REMS submission documents, including:
Our experts have extensive experience in the development of REMS assessment plans and reports. We’ll work with you to:
Our experts have extensive experience in the design of FDA-mandated observational pregnancy safety studies, including:
We have developed protocols, statistical analysis plans, and data collection forms for 20+ pregnancy safety studies, incorporating cutting-edge operational and analytical methods.
We’ll work with you to develop deliverables related to your pregnancy study, including:
We can serve as a subject matter expert in perinatal pharmacoepidemiology or scientific advisory board member.
We can also provide day-to-day scientific oversight for your study, addressing questions from operational staff and/or data analysts and instituting best practices for successful study implementation.
vitepi, LLC was founded in 2024 by Kristin Veley. After a successful career at a major contract research organization, Kristin decided it was time for a change and began offering her consultancy services directly to pharmaceutical and biotech companies. vitepi, LLC is growing, and we'd love for you to be a part of that!
Kristin is a seasoned pharmacoepidemiologist with 13+ years in the industry and extensive experience in pregnancy safety studies and REMS. She's provided scientific oversight and served as the Principal Investigator for 20+ pregnancy safety studies and 10+ REMS programs. She earned her PharmD from the University at Buffalo (Buffalo, New York) and her MPH, with a focus in epidemiology and biostatistics and a certificate in maternal and child health, from Johns Hopkins University (Baltimore, Maryland). She is a dedicated, quality-driven, thoughtful leader who enjoys providing evidence-based and efficient solutions for her clients.
For more information related to Kristin's experience, please see LinkedIn or request her CV using the Contact Us form below. Testimonials from current or former clients are also available upon request.
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