Clinical Trials Office
Provides Financial, Legal and Administrative Support
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.
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.
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:
- 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.
- 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).
- 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.
- Monthly Clinical Research Coordinator Rounds, sponsored together with BIDMC's Institutional Review Board (IRB).
- Ad hoc meetings with investigators and study coordinators to address study-specific needs and concerns.
- Aid in the development and maintenance of standard operating procedures for individual programs and departments.