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Phase 1 Clinical Trial and Strategic Development Services Facility
SRI’s Phase 1 Clinical Trial and Strategic Development Services unit operates a state-of-the-art clinical trial facility to provide clients and partners with comprehensive early-stage human research capabilities for new medicines and medical devices. As part of SRI Biosciences, the research leverages research and development (R&D) capabilities at other SRI locations, including SRI's Menlo Park, California headquarters, to provide integrated, comprehensive support and extend product development continuity from the preclinical to the clinical phase.
The Phase I Clinical Trials facility was completed late 2014 and occupies a purpose-built, approximately 9,400 square-foot expansion of the Michigan Life Science and Innovation Center in Plymouth, Michigan, which is centrally situated near academic medical centers in Ann Arbor, Detroit, and Royal Oak and within 20 minutes of the Detroit International Airport. With support from the Michigan Economic Development Corporation (MEDC), the facility was established to advance business, innovation, and human health in this region and beyond.
Phase 1 Clinical Research and Operations
The unit offers Phase 1 clinical studies in patients and healthy volunteers. The 13-bed and 3-infusion chair, state-of-the-art facility includes the examination and research subject rooms and office, reception, pharmacy, and laboratory processing space necessary to enable Phase I clinical research operations and overnight stays for research subjects. Studies include integrated single and multiple ascending dose studies, bioequivalence studies, food-effect studies, and drug-drug interaction studies, as well as Phase 1b trials in patients drawing on a patient base managed by therapeutic area specialists in multiple areas. Access to SRI’s existing strengths in biomarker development facilitates Phase 1b studies in patients with translational biomarker endpoints, which serves to mitigate the risk of late-stage clinical development failure.
Clinical Strategy Development
The unit provides early strategic guidance in the refinement of efficient, scientifically sound development plans leading to a future drug product or device that addresses a well-defined, unmet medical need. The unit’s capabilities build on decades of SRI experience in clinical development and translational medicine across many therapeutic areas in the biotechnology, biopharmaceutical, and nonprofit sectors. Investigators apply SRI Biosciences’ strategic insight, scientific depth and resources, biomarker development and validation strengths, and executional expertise to design and implement customized clinical research programs that maximize the potential for regulatory and commercial success.
View a list of the unit's capabilities and services.