CPCS Services

Complete Study Management

The Center for Preclinical Studies is a premier Testing Facility serving the biomedical research community in the advancement of novel and translational medical technologies from exploratory R&D through to translational and late-stage testing. Established in 1994 at the University of Pittsburgh’s McGowan Institute, the Center maintains a team of experienced personnel providing academic researchers and Industry Partners complete study management support from careful planning, compliance, study development, application investigational materials/devices, in-life data collection and management through to post-study evaluation and archiving…

READ MORE

Quality Management System

The MIRM-CPCS is a Pitt service center operating under the guidance of an internal Quality Management Systems (QMS) program implementing elements based on the Food and Drug Administration’s Good Laboratory Practices Regulations (21CFR58) as the general reference standard for quality and data integrity. The CPCS QAU Program emphasizes an approach of continual process improvement by the implementation of a “tiered system” of standard operating procedures (SOPs) supporting ongoing personnel training, stringent documentation standards, data collection practices, and equipment maintenance and calibration schedules. These documents are controlled in our electronic Quality Management…

READ MORE

Testimonials

“Since the start of the collaboration with MIRM CPCS we felt at home and their team as an extension of our staff. We found a passionate group of people with a lot of experience in the field whose sole goal is to make your program successful. Moreover, MIRM’s facility is adapted to our needs. The CPCS has a dedicated and experienced team with a facility, professional OR and lecture facilities that allows privacy and focus for you and your customers. CARMAT selected the CPCS as the sole US Training Center supporting the qualification of surgeons from all US Clinical Trial sites. Initiated in 2019, Carmat has completed fifteen training events; we look forward to continuing this relationship.”
Francesco Arecchi, Director of Global Market Development for Carmat

“Founded in 1998, XVIVO (Gothenburg, Sweden) is the only medical technology company dedicated to extending the life of all major organs – so transplant teams around the world can save more lives. XVIVO is the forerunner in life-extending technologies for organs. We lead the way by following the science. Our solutions allow leading clinicians and researchers to push the boundaries of transplantation medicine. XVIVO provides clinically optimized solutions for organ, tissue and cell preservation and perfusion in connection with transplantation. Our state-of-the-art devices allow for oxygenated machine perfusion during preconditioning, preservation, reconditioning and transport of organs. During the development of our Liver Assist, XVIVO’s subsidiary Organ Assist from Groningen, The Netherlands, intensively collaborated with the Thomas Starzl Transplantation Institute of the UPMC, and the Pitt McGowan Center for Preclinical Studies. Within the CPCS Test Facility, the Liver Assist was evaluated in a preclinical liver transplantation study on the safety and efficacy of 9-hour ex vivo machine perfusion at room temperature using an innovative oxygen-carrier solution (VirTech Bio, Natick MA) compared to static cold storage. For this purpose, the team experts at the CPCS, in close collaboration with the surgeons from UPMC, developed a new pig liver transplantation model, including 5-day follow-up under GLP conditions. Results show survival of 6 out 6 in the study group compared to 2 out of 6 in the control group. The study was published in the American Journal of Transplantation (AmJTx 2015;15:381-394) Based on the study, XVIVO has received regulatory approval of the Liver Assist in Europe, Brazil, and Australia, and more than 2000 patients received a new liver perfused in the Liver Assist. The collaboration with the McGowan CPCS played a significant role in realizing XVIVO’s mission: Nobody should die waiting for a new organ.”

Arjan Van Der Plaats, PhD, Research and Development Director for XVIVO

Latest News

  • Shunt to Treat Fetal Hydrocephalus In-Utero

    "In 2014 the 25 Club donated $200,000 to the fetal therapy program, allowing me to spearhead an international evidence-based reas ...

    READ MORE
  • McGowan Institute Quality Management Specialists Assist Pitt’s Center for Vaccine Research and Others

    McGowan Institute for Regenerative Medicine affiliated faculty member Shawn Bengtson, RQAP-GLP, Director, Quality Assurance-Quali ...

    READ MORE
  • Pitt-McGowan Institute Center for Preclinical Studies Supports Total Artificial Heart Study

    Carmat, a developer of an artificial heart which offers a bridge to transplant in patients with end-stage biventricular heart fai ...

    READ MORE