Clinical Trials Office

Clinical Trials Office Information

The Clinical Trials Office (CTO) provides a central and comprehensive program of financial, legal and administrative support to the research community at BIDMC, in keeping with the institution's mission of health care, education and the advancement of knowledge.

Beth Israel Deaconess Medical Center (BIDMC) conducts clinical research in a variety of clinical specialties. 

Nationally Recognized Clinical Trials Center

Since its inception in 2003, the CTO has become a nationally recognized clinical trials center, known for its excellence in clinical research management by industry sponsors, the National Institutes of Health and other national and international academic medical centers.

Our Services

The CTO seeks to bring industry sponsors and investigators together to conduct research in specific therapeutic areas and to promote new initiatives and expand clinical research programs at BIDMC.

The CTO comprises ten skilled professionals with significant expertise in the healthcare industry. Staffed with financial analysts, contract specialists, billing and regulatory experts, this centralized office presents a variety of services including but not limited to the following:

Contracting Services

  • Confidential Disclosure Agreement (CDA) review, negotiation and approval
  • Clinical Trial Agreement (CTA) review, negotiation and approval
  • Subcontract Agreements to and from other healthcare institutions
  • Conflict of Interest and Risk Management assessment

Financial Services

  • Developing and negotiating budgets for industry-sponsored and investigator-initiated studies
  • Conducting comprehensive cost analyses for NIH and foundation-sponsored clinical trials
  • Financial monitoring and administrative oversight of clinical trial accounts
  • Auditing of clinical trial accounts for study close-out and related reporting activities
  • Overseeing device clinical trial approval through the Centers for Medicare & Medicaid Services (CMS)

Educational Services

  • Ongoing compliance training in federal guidelines for the proper drug and device study billing
  • Personalized meetings with investigators and study teams to explain and customize CTO services and operations

Sponsor Resources at the Clinical Trials Office

The CTO is dedicated to facilitating the relationship between sponsors and our investigators conducting industry-supported clinical trials by providing a menu of centralized services including the preparation, negotiation, and execution of budgets and contracts.

We recognize the importance of bringing medical innovation to patients expeditiously and therefore strive to meet short deadlines and quick turnaround times, while maintaining ethical and quality standards expected of a Harvard affiliated Medical Center.

Additional Links