ICON offers expertise in the development and management of all aspects of organ transplant clinical trials from the earliest development to the late post – marketing environment.
Our clinical trial experience includes, but is not limited to, the following transplant indications:
- Kidney / Pancreas
- Stem Cell
Data and Safety Monitoring Boards (DSMB) are routinely created in organ transplant clinical trials to ensure patient safety. DSMB recommendations are immediately addressed by the sponsoring companies. ICON maintains a database in transplant medicine and surgery in order to assist sponsors in creating and maintaining DSMBs throughout the duration of the study and during the post-marketing phase.
Our global investigator database includes over 85 organ transplant investigative sites across more than 20 countries. We have worked with a wealth of specialty investigators in the areas of Renal Transplantation, Hematology (Stem Cell and Bone Marrow Transplantation), Abdominal Transplantation, Hepatologic Transplantation, and Neurological Transplantation.
ICON’s Transplant TAG is comprised of in-house therapeutic specialists who are highly-experienced in managing trials in the field of organ transplantation. The group includes representatives from all line functions whose role it is to interface with and oversee service operations to enhance the ability to successfully conduct clinical studies. In particular, ICON’s Transplant TAG members have extensive experience in overcoming challenges associated with patient enrollment and have built a close network of thought leaders, investigators, and clinical professionals throughout the world who are available to consult on individual projects.
In addition to providing support and guidance to the study team, the main responsibilities of the TAG team include:
- Global project feasibility
- Protocol development, review and evaluation
- Clinical trial planning
- Therapeutic training and advice
- Project oversight
- Consulting, medical monitoring and advisory board representation
- Interpretation of the clinical data
- A 24-hour, global physician “on call” system to assure that no enrollment opportunity is missed