Clinical Trials and Sponsored Translational Research
The Clinical Microbiology program at Beth Israel Deaconess Medical Center has extensive experience partnering with industry sponsors to perform regulatory-grade evaluations of diagnostic devices and assays. We serve as a clinical trial and method evaluation site for manufacturers developing new clinical microbiology diagnostics, including studies designed to support FDA clearance and approval.
Our group routinely conducts sponsor-initiated and investigator-initiated performance studies under institutional and regulatory oversight, and we are well positioned to participate as a clinical trial site for 510(k), PMA, and other FDA-directed submissions. We have experience operating under master services agreements (MSAs) and collaborating with regulatory, clinical affairs, and assay development teams.
Capabilities and Expertise
Translational Research and Antimicrobial Evaluation
In addition to diagnostic device trials, we develop and maintain well-characterized bacterial strain sets for evaluation of new antimicrobial agents. We collaborate with pharmaceutical and biotechnology partners to test novel compounds against in-house collections representing clinically relevant and resistant pathogens, supporting translational research and early development decisions.
Industry Collaboration
We welcome inquiries from diagnostic and biotechnology companies interested in:
For discussions regarding diagnostic trials, regulatory studies, or translational research collaborations, please contact:
Stefan Riedel, MD, PhD
Clinical Microbiology
Beth Israel Deaconess Medical Center
📧 [email protected]
You may also contact James Kirby, MD ([email protected]).
Please indicate that you were referred via clinmicrolab.org.
Our group routinely conducts sponsor-initiated and investigator-initiated performance studies under institutional and regulatory oversight, and we are well positioned to participate as a clinical trial site for 510(k), PMA, and other FDA-directed submissions. We have experience operating under master services agreements (MSAs) and collaborating with regulatory, clinical affairs, and assay development teams.
Capabilities and Expertise
- Evaluation of molecular, culture-based, and phenotypic diagnostic platforms
- Clinical performance studies supporting FDA submissions
- Experience with method comparison, specimen type validation, and workflow assessment
- Access to diverse, contemporary clinical isolate collections, including bacteria, fungi, and emerging resistance phenotypes
- Expertise in antimicrobial susceptibility testing and resistance characterization
- Ability to support prospective and retrospective study designs
Translational Research and Antimicrobial Evaluation
In addition to diagnostic device trials, we develop and maintain well-characterized bacterial strain sets for evaluation of new antimicrobial agents. We collaborate with pharmaceutical and biotechnology partners to test novel compounds against in-house collections representing clinically relevant and resistant pathogens, supporting translational research and early development decisions.
Industry Collaboration
We welcome inquiries from diagnostic and biotechnology companies interested in:
- Clinical trial site participation
- Sponsored performance evaluations
- Regulatory-directed studies
- Long-term collaborations under MSAs
For discussions regarding diagnostic trials, regulatory studies, or translational research collaborations, please contact:
Stefan Riedel, MD, PhD
Clinical Microbiology
Beth Israel Deaconess Medical Center
📧 [email protected]
You may also contact James Kirby, MD ([email protected]).
Please indicate that you were referred via clinmicrolab.org.