Phase 1 Clinical Trials and Strategic Development Services | SRI International

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Phase 1 Clinical Trials and Strategic Development Services

From Concept to Clinic

Initiation of Phase 1 clinical trials for a drug, biologic, or medical device represents a key point in its translational development. Early-stage biopharmaceutical companies, med-tech, academic, and government organizations turn to SRI Biosciences as a research partner that can optimize trial efficiency and outcomes while reducing downstream development risk. 

SRI Biosciences, a full-service, independent medical research organization and leader in translational R&D, operates a state-of-the-art facility to provide clients and partners with comprehensive early-stage human research capabilities for new medicines and medical devices.

Our Phase 1 Clinical Trial and Strategic Development Services unit, located at a state-of-the-art 16-bed facility in Plymouth, Michigan, provides clients with access to an agile, top-tier development organization with the capacity to carry programs from ideas to early human trials. Our capabilities leverage SRI Biosciences’ core competencies to provide integrated, comprehensive support and extend product development continuity from the preclinical to the clinical phase.

The unit offers single- and multiple-dose Phase 1 clinical studies in patients and healthy volunteers. Studies include integrated single and multiple ascending dose studies, food-effect studies, bioequivalence studies, and drug-drug interaction studies.

Strategic Guidance

The unit’s executional support is integrated with strategic drug development input provided by a team with, in aggregate, decades of private sector development experience. Investigators apply SRI Biosciences’ strategic insight, scientific 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.  

Particularly for small or virtual biotechnology companies, the facility fills a need that is not prioritized by large contract research organizations. Early and adequate attention to key strategic elements increases the strength of funding pitches and maximizes the likelihood of FDA acceptance and successful development.

Preclinical Drug Development and Formulation

In conjunction with SRI Biosciences' Toxicology and Pharmacokinetics and Discovery Sciences groups, we offer:

  • IND-enabling preclinical studies evaluating drug safety, as well as pharmacokinetic, toxicity, and animal efficacy model data
  • Dosage form development and cGMP manufacture of investigational products
  • Biomarker discovery, development and validation from preclinical to clinical studies

Clinical Trial Services

  • High-quality design and execution of clinical trials
  • Preparation of clinical protocols, informed consent forms, and other key study documents
  • Operational oversight by a highly experienced director of clinical operations
  • 24-hour medical monitoring and physician investigator availability
  • Electronic data capture
  • Human sample analysis
  • PK-PD analysis
  • Top-line clinical study report

High-Quality Strategic Development Support

  • Creation/refinement of target product profiles
  • Integrated efficient clinical development plans that mitigate risk
  • Analysis of existing and looming competition

Administrative and Regulatory Support

  • Coordination of Institutional Review Board (IRB) review of studies
  • Arrangement, planning and management of pre-IND meetings
  • Preparation of IND submission documents

Location and Study Volunteers

The Phase 1 Unit facility is situated at the Michigan Life Science and Innovation Center, centrally located near academic medical centers in Ann Arbor, Detroit, and Royal Oak and within 20 minutes of the Detroit International Airport.

New medical cures depend on healthy volunteers to participate in research studies of potential new therapeutics, and SRI compensates study participants for their time. Learn more or sign up here.

Projects

Innovative Science Overcomes Formulation Challenges

Innovative Science Overcomes Formulation Challenges

Partnering to Advance Therapy for Radiation Exposure

Partnering to Advance Therapy for Radiation Exposure