Translating preclinical promise into successful Phase I trials represents a significant barrier for biotechs. The University of Rochester Medical Center (URMC) believes it has the expertise and infrastructure to help with this process and has set up CHET to provide related services.
“CHET serves as a critical link between our basic science and patient-oriented research enterprises”, explained Thomas Pearson, director of the Clinical and Translational Science Institute at URMC, located in New York, US.
The project brings together existing capabilities at URMC’s Clinical Trials Coordination Center (CTCC) and Clinical Materials Services Unit (CMSU) to accelerate drug development and eliminate unnecessary failures.
CTCC provides services covering study protocol development, data collection, management and analysis, administrative support and oversight of trial sites. The group has managed more than 70 multi-centre, international clinical trials and will apply this knowledge to help biotechs.
Businesses outsourcing to CHET will also have access to CMSU. This group provides clinical trial supply services, covering production and design of packaging and labels, national and international distribution, storage and the tracking and destruction of returned products.
To support the project URMC is recruiting six additional staff, including biostatisticians and clinical pharmacologists. CHET’s staff and operations will relocate to the Clinical and Translational Sciences building when it opens in March 2011.
When the new site opens it will allow URMC “to assemble under one roof the resources needed by academic and industry scientists that are necessary to answer fundamental questions about their early stage research”.