Leading Transplantation CRO: Driving Innovation in Clinical Research
Medpace brings deep expertise and global execution to transplantation clinical development, spanning solid organ (e.g., renal, hepatic) and hematopoietic stem cell transplantation. Our multidisciplinary teams — including in-house nephrologists, infectious disease specialists, and immunologists — partner with Sponsors to accelerate programs that aim to improve graft survival, minimize rejection, and advance post-transplant outcomes.
Full-Service Transplantation Capabilities
Therapeutic Expertise Across Transplant Indications
Medpace has successfully led global Phase I-III studies across the full spectrum of transplantation-related indications, including:
- Renal Transplantation: Allograft rejection, antibody-mediated rejection (AMR), delayed graft function, and cell therapies for improved allograft outcomes
- Infectious Complications Post-Transplant: Cytomegalovirus (CMV), BK virus, and other opportunistic infections
- Hematopoietic Stem Cell Transplantation: Graft-versus-host disease (GvHD), hematologic malignancies
Optimized Site Selection with Proven Partnerships
Accelerate your transplantation studies through Medpace’s data-driven feasibility strategy and trusted site network. Our IntelliPACE® model integrates internal and external data sources to identify the most suitable countries and sites, while our dedicated patient recruitment and retention team ensures expedited enrollment and reduced dropouts.
Through our Medpace Flagship Sites – a select group of high-performing global transplant centers – Sponsors gain access to networks with a proven track record of delivering timely, quality outcomes. These strong, global relationships streamline study start-up, enhance enrollment, and ensure consistent, high-quality data capture across complex transplantation programs.
Comprehensive Lab Support
Medpace’s central and bioanalytical laboratories provide comprehensive testing and logistics support for transplantation studies, ensuring quality, consistency, and scientific rigor. With four wholly-owned central labs in the US, Europe, China, and Singapore, Medpace has the global reach to support studies, assist with regulatory requirements and deliver custom solutions to support your transplantation study. Combined with Medpace CRO expertise, we provide a fully integrated solution for your clinical development needs.
Medpace labs offer full-service support for:
- Pharmacokinetic (PK) and immunogenicity testing
- Biomarker analysis to evaluate immunosuppressive therapy and graft function
- Cytokine profiling and flow cytometry-based assays
- Histopathology and molecular testing for allograft injury and gene expression profiling
- Viral load testing in transplanted patients including CMV, EBV, BKV, ADV, JCV and HHV6
- Chimerism by STR testing
Operational Excellence in Complex Transplant Studies
Transplant trials require precise planning and real-time oversight. Medpace’s end-to-end operational collaboration ensures seamless execution from donor-recipient coordination to long-term follow-up.
Perfusion and Organ Preservation
Clinical evidence shows that organ perfusion is critical for graft survival. Medpace prioritizes perfusion by integrating machine perfusion technologies, standardized protocols, and real-time monitoring to ensure consistent graft quality, reliable endpoints, and high-quality trial data.
Integrated Medical and Regulatory Leadership
Every transplantation clinical trial run by Medpace is guided by a hands-on medical affairs team. Our medical experts (many of whom have managed transplant patients in academic and clinical settings) are embedded throughout the trial lifecycle and work side-by-side with clinical operations and regulatory specialists to:
- Navigate evolving regulatory pathways for advanced therapies and biologics
- Develop scientifically sound, risk-based monitoring strategies
- Ensure alignment with regional guidelines (FDA, EMA, MHRA, PMDA)
Collaborative & Cross-Functional Teams to Execute Your Transplant Study
At Medpace, collaboration is at the core of our success in transplantation clinical research. Our integrated teams—spanning medical, regulatory, and operational experts—work seamlessly to provide strategic oversight and execution at every stage of development. This synergy allows us to anticipate challenges, adapt strategies, and drive meaningful advancements in solid organ transplant research. Explore our expert leaders who are shaping transplant research:
Franklin O. Smith, MD, FAAP, FACP
Sr. Vice President, Medical Department
Dr. Franklin Smith is a distinguished pediatric hematologist-oncologist with over 41 years of specialized clinical and research expertise in hematopoietic cell transplantation and cellular therapy. He was a member of the transplantation faculty at the Fred Hutchinson Cancer Research Center and University of Washington, served as the Director of the Stem Cell Transplantation Program at Riley Hospital for Children and Co-Director of the adult Bone Marrow Transplantation Program at Indiana University, Director of the Division of Hematology/Oncology/Transplantation at Cincinnati Children’s Hospital Medical Center, and the Inaugural Director of the adult Bone Marrow Transplantation Program at the University of Cincinnati. He served as an officer and member of the Board of Directors of the Foundation for the Accreditation of Cellular Therapy (FACT) and was the Founding President of FACT Consulting Services. His extensive transplant experience encompasses both autologous and allogeneic hematopoietic stem cell transplantation for malignant and non-malignant diseases in pediatric and adult populations. He has been a pioneer in cord blood transplantation, leading groundbreaking scientific and clinical research. He has had NIH funding to support his research, including program grants that include the National Heart, Lung and Blood Institute’s Transplant Centers for Clinical Research on Transplantation of Umbilical Cord Stem and Progenitor Cells. He has published extensively in the medical and scientific transplant literature.
Ajay Srivastava, MD, FASN
Vice President, Medical Department
Dr. Ajay Srivastava is a board-certified nephrologist with an extensive background in both clinical and academic medicine. Specializing in adult nephrology, he brings over 20 years of experience in both the common and rare conditions of the kidney, renal replacement therapies, ICU nephrology including IV fluid resuscitation and management and comorbid conditions such as cardiorenal syndrome and hypertension. As an interventional nephrologist, he also provided education, assistance and evaluation regarding matters of dialysis vascular access including the performance of interventional procedures to preserve, optimize and salvage these hemodialysis accesses. Dr. Srivastava has also held several other leadership positions including Director of Nephrology Fellowship Training, the Medical Directorship of dialysis facilities, Division Chief of Nephrology and Interim Chair of Medicine, and has served on a number of departmental, hospital and university committees.
Ann Woolfrey, MD
Vice President, Medical Department
Dr. Ann Woolfrey is board-certified in pediatric hematology-oncology and internal medicine. She served as Professor at the University of Washington and Fred Hutchinson Cancer Research Center with over 25 years of specialized expertise in hematopoietic stem cell transplantation. She served as Director of the Unrelated Donor Marrow Program at Seattle Cancer Care Alliance for 13 years, providing medical leadership for donor search processes and transplant care. Her extensive clinical and research experience encompasses unrelated donor and HLA-haploidentical transplantation for both malignant and non-malignant diseases, graft-versus-host disease prophylaxis and management, donor-specific anti-HLA antibodies in unrelated donor transplantation, and immune reconstitution following hematopoietic stem cell transplantation in pediatric and adult populations.
Phillip Cole, MD
Sr. Medical Director
Dr. Phillip Cole is a board-certified infectious disease specialist with expertise in transplant infectious diseases. He brings global clinical trial experience from the Sponsor and CRO perspective, in hematopoietic stem cell transplant (HSCT) and solid organ transplant (SOT) recipients, and covering indications in opportunistic viral infections (CMV, BKV) and invasive fungal diseases. Dr. Cole’s clinical background is in hospital medicine and adult ID inclusive of transplant ID and HIV care in the academic and community setting as well as service on various hospital committees (antimicrobial stewardship, infection control and prevention).
Maxime Jeljeli, MD, PhD
Medical Director
Dr. Maxime Jeljeli is a physician-scientist and clinical immunologist with extensive translational research and clinical expertise in transplantation immunology. As reflected by his publications track record, his experience encompasses the clinical management and immunological monitoring of transplant recipients, including immune reconstitution assessment (naïve and memory T- and B-cell subsets) and viral load monitoring for CMV and EBV reactivation following allogeneic stem cell transplantation, kidney transplantation, and vascularized composite allotransplantation and graft-versus-host disease. He has specialized expertise in immune tolerance and induction protocols, including co-stimulation blockade, irradiation combined with bone marrow transplantation, and regulatory T-cell–based approaches. His recent research has investigated the role of dysregulated innate immune response, inflammatory memory and immune cell reprogramming in the pathogenesis of graft rejection and focused on biomarker discovery to monitor allograft rejection and evaluate the efficacy of immunomodulatory and targeted therapies without the need for chronic immunosuppression.
Sara Rhoten, MSN, RN
Advanced Clinical Practitioner
Sara Rhoten is a board-certified nurse practitioner with nearly 20 years of clinical expertise in kidney disease management and transplantation. Specializing in the care of kidney and pancreas transplant recipients, she brings extensive experience across the entire transplant continuum, from pre-transplant coordination, desensitization, and waitlist management to post-operative care and long-term immunosuppression management. Her background includes serving as a pre- and post-kidney-pancreas transplant coordinator, providing direct nursing care to solid organ transplant recipients (kidney, pancreas, and liver), and managing dialysis patients on the kidney transplant waitlist. She is experienced in the treatment of post-transplant complications and infections such as BKV and CMV.
Sudha Alphonse, MSc, RN
Advanced Clinical Practitioner
Sudha Alphonse is an accomplished advanced clinical nurse practitioner with over 18 years of experience in nephrology and kidney transplantation across international healthcare settings. Specializing in the comprehensive management of transplant patients, she brings extensive expertise in donor and recipient assessment, transplant coordination, post-operative and follow up care for both living and deceased donor kidney transplants. Her clinical background encompasses preparing both dialysis and pre-dialysis patients for renal transplantation including ABO-incompatible renal transplants, coordinating transplants in operating theatres with immediate post-operative management, monitoring and managing immediate and long-term renal transplant complications in transplant follow up clinics, and failing transplant clinics.
Nel Van Lommel
Sr. Director, Clinical Trial Management
Nel Van Lommel is a seasoned clinical research professional with over 27 years of experience in clinical trial management across pharmaceutical and biotechnology industries. Specializing in the oversight of complex global clinical programs, she brings extensive expertise spanning Phase I-IV studies in diverse therapeutic areas including nephrology, rare diseases, immunology, musculoskeletal disorders, and rheumatology. With 18 years dedicated to clinical trial project management, Nel currently serves as Senior Director of Clinical Trial Management at Medpace in Leuven, Belgium, where she leads the company’s Transplant Working Group.
Award-Winning Site Partnerships
Medpace was named the 2025 SCRS Eagle Award recipient for CROs – a recognition awarded by nearly 2,000 research sites worldwide recognizing our commitment to operational excellence and trusted site collaboration.
