Research Partnership Opportunities

How to get started?

Site Feasibility Overview

If Sponsor is interested in a potential research collaboration with BMC, please contact BMC’s Clinical Trial Office (CTO@bmc.org). The Clinical Trial Office is BMC’s central office for industry-sponsored research. CTO facilitates the review of legal contracts, negotiates budgets, and manages financial activities for industry-sponsored research projects.

Sponsor may also directly contact our Investigators, if Sponsor would like to collaborate with a specific Investigator or research team. If interested, the Investigator will notify CTO to start the CDA/NDA process (see next).

CDAs & NDAs

When BMC and Sponsor are interested in a potential research opportunity, the parties execute a confidentiality disclosure agreement (CDA) or non-disclosure agreement (NDA). The Sponsor will send a CDA/NDA template to BMC, or upon request, BMC can provide the CDA template to review. Upon execution of the CDA/NDA, BMC and Sponsor may share information regarding the research and BMC will complete any site feasibility questionnaires required by the Sponsor.

The general timeline for CDA/NDA review is 1-2 business weeks at our institution.

For multiple potential collaborations, BMC recommends executing a Master CDA/NDA with the Sponsor to streamline the site feasibility process.

What does BMC offer?

 Boston Medical Center is a not-for-profit academic medical center based in Boston, MA. Our mission is to provide exceptional care without exception to the community. We believe our diverse patient population deserve the best care and service, and that includes research opportunities to improve the future of health and medicine.

Our world-renowned researchers currently oversee 661 research projects, including both laboratory-based research and clinical research programs in areas such as substance use disorder, violence intervention, infectious disease, geriatrics, and hematology/oncology.

Areas of Interest for Research Opportunities

• Endocrinology – various diabetes studies
• Gastrtoenterology – ulcerative colitis, non-alcoholic steatohepatitis, short-bowel syndrome Geriatrics
• Hematology & Oncology – various cancer types
• Nephrology – lupus nephritis, biopsy studies Neurology – stroke, Parkinson’s disease, Alzheimer’s disease
• OBGYN – neonatal health, anal cancer, contraceptive studies, STD studies
• Ophthalmology – various eye disease studies
• Pediatrics – flu vaccine studies
• Radiology – various imaging studies
• Substance user disorder (does this fall under Psychiatry or stand-alone category?)
• Surgery - vascular & endovascular surgery studies

Community-Engaged Research

At BMC, we seek to make sustainable changes in the research process to improve the health of the communities we serve. “Equity in research” means that everyone has a fair and just opportunity to engage in research, to be as healthy as possible, regardless of gender, caste, sex, race, ethnicity, class, sexuality, religion, disability, etc. BMC, the CRN, and our Community Advisory Board prioritize a community engaged approach as a means for creating fair and just opportunities for everyone to participate in research. Specific groups are “hardly reached” or engaged in research, particularly those historically excluded, under-represented and under-resourced; these groups generally experience the greatest disparities in health.

Best Practices for Equity in Research Focus on 4 Key Areas:

• Community Centeredness: Prioritize the community’s needs and interests as a driving force behind the research
• Communication Methods: Use verbal and nonverbal communication (e.g. written, visual, listening body language) that is welcoming and reflects that diversity is valued
• Institutional Barriers: Create opportunities for research participation by shifting institutional practices and developing protocols that reflect that equity is valued
• Intersecting Factors: Recognize overlapping cultural, social, and economic identities that may be both empowering and oppressing

Inclusion & Diversity

One of our main selling points is our unique and diverse population.

Diversity, Equity, and Inclusion

View Clinical Research Network

Mission: Grounded in health equity, the Clinical Trial Office (CTO) and Clinical Research Network (CRN) co-exist to provide centralized services that increase opportunity and promote financial growth of clinical research discovery and innovation at Boston Medical Center and Boston University. In addition to serving the research community with institutional support and oversight of clinical research, BMC is committed to integrated partnerships between academic researchers, community partners and patients, and research sponsors through community engaged values.

Vision: Encourage the advancement of science with and for all people.

Our Patients:

• 1 in 3 identify as Black
• 1 in 4 identify as Latinx
• 1 in 4 experience food insecurity
• 1 in 10 of our hospitalized patients are unhoused or housing insecure
• 50% live at or below the federal poverty level

In an average year, we serve patients through more than:

• 1.3 million visits
• 24,000 admissions
• 132,000 emergency department visits; 
• busiest ED in the NE
   

Local Investigational Pharmacy Services (IPS)

Investigational pharmacy services refer to specialized pharmaceutical services that support clinical trials and other research studies involving investigational drugs or medical devices. These services typically include the management and distribution of study drugs, as well as the provision of clinical and administrative support for research teams.

Some common investigational pharmacy services include:

1. Investigational drug management: This involves the acquisition, storage, and distribution of investigational drugs to study participants according to the study protocol.
2. Pharmacy monitoring: This includes monitoring patients' drug therapy to ensure that medications are being taken correctly and to identify any potential drug interactions or adverse effects.
3. Clinical support: Investigational pharmacy services may also provide clinical support to study teams, including developing study protocols and assisting with data analysis.
4. Regulatory compliance: Investigational pharmacy services are responsible for ensuring that all regulatory requirements related to investigational drug management and distribution are met.
5. Patient education: This involves providing education to study participants about the investigational drug and the study protocol.

Overall, investigational pharmacy services play a crucial role in the success of clinical trials and research studies by ensuring that investigational drugs are safely and effectively managed and administered to study participants.

Central & Local IRB review

Focus on ability to facilitate both local and central. Need to check INSPIR website to add description

Boston Medical Center has the ability to conduct human subject’s research that utilize both local and central Institutional Review Board (IRB) reviews, which is highly beneficial for its research initiatives. Local IRB reviews are conducted by Boston University IRB for full board, expedited, exempt, and ceded review (when central IRB required). Central IRB reviews are performed by an external IRB, which is approved by the institution to review its research studies. By having the ability to conduct both local and ceded IRB reviews, BMC is able to streamline its research review process and provide greater flexibility to its research teams. This allows the institution to conduct studies that require different types of governance, and also enables it to collaborate more effectively with other institutions and researchers. Additionally, having both local and central IRB review options ensures that BMC's research is conducted in an ethical and compliant manner, while also minimizing administrative burden and potential delays in the review process.

On-site & Remote Monitoring

BMC permits both on-site and remote monitoring for our research projects. Monitor’s employer are required to complete a Memo of Understanding (MOU). Additionally, monitors are required to sign a Confidentiality Disclosure Agreement (CDA) prior to accessing the hospital EMR system. The user system access process takes at least 5 business days to complete and should be setup prior to first monitoring visit. On-site monitors will need to follow our hospital visitor guidelines.

View more visitor information

CLIA Certification

We are CLIA certified – email Erin.Norberg@bmc.org (Operations Director of Laboratory Medicine at Boston Medical Center) for copy of certificate

Who to contact?

Clinical Trial Office (CTO@bmc.org)