Massachusetts Medical Device Development Center

UMass Worcester

m2dsworcesterUMass Worcester, home of UMass Medical School, offers access to expertise and consultation across a broad range of medical areas. With its clinical system partner, UMass Memorial Medical Center, UMass Worcester can support clinical trial needs and ensure efficient study conduct from initiation through study close-out.

As a central point of contact, the Office of Clinical Research (OCR) can identify interested and experienced clinical investigators and assist them with recruitment and retention plans that maximize participation throughout the life cycle of the study. With 760 beds on three Worcester campuses, UMass Memorial Medical Center provides a rich resource for potential clinical trial enrollees.

Medical device and technology studies currently cross various therapeutic areas, including plastic surgery, cardiology, infections, intervention radiology, digestive diseases, orthopedics, pediatrics, otolaryngology, general surgery and intensive care for adults, children and newborns. Umass Worcester's contribution to M2D2 includes:

  • Feasibility review and study budget assessments
  • Thorough and timely review of Clinical Study Agreements
  • Regulatory document support, IRB draft prep and FDA communications (e.g., IND and IDE requests)
  • Continuing education of investigators and research staff in Good Clinical Practice (GCP)
  • Quality Improvement Initiative
  • Clinical Trials Unit: dedicated research space (four exam rooms, infusion room, small laboratory), regulatory support and experienced research coordinators

A Clinical Researcher's Perspective

Babs Soller, Ph.D. is one of many researchers at the UMass Worcester campus who tap into the services of the Office of Clinical Research to facilitate study initiation.  As a professor in the departments of Anesthesia, Surgery & Biomedical Engineering, Dr. Soller has conducted federally supported projects and collaborated with industry. Particularly interested in the application of optical spectroscopy for the noninvasive measurement of blood and tissue chemistry, she aims to be able to perform chemical analysis and diagnosis without removing a sample from the patient.

"Our Office of Clinical Research at UMass Worcester is a great resource for scientists conducting clinical research for the first time. Recent changes in the flow of contracts and institutional approval have helped investigators improve study initiation timelines. Research coordinators conducting my device studies have received excellent preparation through the Office's training programs," she says.