Proven Leadership in Impairment Studies
Purpose-built impairment model
Fortrea has conducted more than 170 Phase I renal/hepatic impairment studies. Extensive experience in standalone and joint renal/hepatic impairment designs, enabling sponsors to realize operational efficiencies and potential cost savings.
Experience spanning since 2006
Experienced team (some with tenure >25 years)
Strong site relationships
Extension of our team, extremely responsive
Comprehensive site database
Phase I impairment sites in >10 countries across the world
Robust Medical Monitoring Process
Patient safety and data integrity are central to Fortrea’s impairment studies. Screening and Day ‑1 data are reviewed by Fortrea’s medical monitoring team, providing an additional layer of oversight beyond standard site review.
Benefits of this approach include reduced enrollment of ineligible participants, fewer dropouts, and increased data reliability. This process has been refined over more than 20 years and is widely valued by investigative sites.
Global Access to Impairment Populations
Access to stable suitable and well‑characterized impairment populations is critical to study success. Fortrea works with a global network of experienced investigators and sites, including those that have previously demonstrated a capability of enrolling severe hepatic impairment participants. Our global footprint spans – North America, EMEA and APAC.
With master CDAs and CTAs in place with many sites, Fortrea supports faster start‑up and efficient execution across regions
Sponsors benefit from:
Experienced teams familiar with impairment nuances Strong, long‑standing site relationships Consistent execution, communication, and quality
Our Renal and Hepatic Impairment leaders
A deep, dedicated bench of qualified pharmacists and support staff
Dr. Stephen Flach
Executive Medical Director
Stephen Flach, Md, PhD, is a board-certified internist who has worked in Clinical Pharmacology since 2005 as a Principal Investigator, Medical Monitor, and Consultant on a wide range of early phase drug development projects. He has helped design and execute numerous renal and hepatic impairment studies since 2017. He is an author on over 40 peer reviewed publications. He was an internal medicine resident on the Osler Medical Service at the Johns Hopkins Hospital and subsequently was a fellow in General Internal Medicine at the University of Pennsylvania. Prior to working at Fortrea, Dr. Flach was on the faculty at the University of Iowa College of Medicine.
Dr. Barbara Lomeli
Senior Medical Director, Medical Monitor
Dr Lomeli received her Medical Degree (MD) from the University of Kansas, Internship in Internal Medicine at the University of Iowa, and Residency in Emergency Medicine at the UMKC School of Medicine in Kansas City. UMKC Staff in Emergency Medicine for two years post graduate. Practiced ER Medicine as Board Certified in Emergency Medicine Physician from 1985- 2011. Principal Investigator at Quintiles Phase 1 Unit in Overland Park Kansas, 2011-1018.
Dr Vanja Vucetic
Medical Director/Medical Monitor, Medical & Scientific Affairs
Dr Vanja Vucetic is a board certified Clinical Pharmacology specialist and licensed Medical Doctor, educated at the University of Belgrade, Serbia. With over 18 years of experience in clinical pharmacology and global clinical research, developed expertise in medical monitoring, protocol development, and safety oversight across Phase I–IV clinical trials. Focused on early phase development and complex, multi therapeutic programs, and managed studies in diverse therapeutic areas including cardiometabolic disease, neuroscience, oncology, gastroenterology, and immunology.
Dr Sunu Valasseri MBBS, MSc, DPM
Senior Medical Director
Dr. Sunu Valasseri is a Senior Medical Director within Clinical Pharmacology Services at Fortrea, with approximately 16 years of experience in Phase I clinical research. He provides medical oversight and safety monitoring for early phase clinical trials, with experience across more than 150 studies, including First-in-Human, drug–drug interaction, bioequivalence, thorough QT, and radiolabeled studies.
Prior to joining Fortrea, Dr. Valasseri served as a Principal Investigator at Labcorp’s Leeds facility, leading multiple First-in-Human programs with a strong focus on subject safety and regulatory compliance. He holds an MBBS, a Diploma in Pharmaceutical Medicine (UK), and an MSc in Pharmacology, and is actively involved in medical appraisal and academic activities.
Jeanelle Kam, MD, MBA, CPI
Senior Medical Director
Dr. Kam is a trained OB/GYN with more than a decade of CRU early drug development experience across multiple indications. As a Certified Physician Investigator (CPI) and Medical Director at the Phase I Dallas CRU, Dr. Kam conducted over 200 trials in BE, DDI, FE, FIH, Japanese Bridging and TQT studies. In 2022, she joined the CPS Medical Scientific Team as a Phase I Medical Monitor and currently is one of the Senior Medical Director at Fortrea. Her expertise in Women’s Reproductive Health includes serving as PI on OC-DDI studies, consultation of endometriosis, lactation and post-menopausal studies. She was the lead author for Fortrea’ s birth control guidance, “Evidence-Based Guidance for Contraceptive Use in Phase I and Clinical Pharmacology Trials Including Women of Child-Bearing Potential” and presentation of the guidance at the 2015 Annual Meeting for ACCP poster session.