Pre-Clinical & Clinical Trials
Where Bench to Bedside Happens
The Roswell Park GMP Engineering & Cell Manufacturing (GEM) Facility offers a robust and comprehensive platform designed for scalability across different developmental phases. Whether you're engaged in proof-of-concept studies, investigator-initiated trials, multi-center trials supported by substantial grants, or path to commercialization, our facility possesses the specialized knowledge and experience crucial for advancing your novel therapy.
Collaborating with the Roswell Park GEM Facility integrates your team into our extensive network of top-tier scientists, technicians, physicians, patients, and providers.
Benefit from our decades-long expertise in translating fundamental scientific knowledge into studies conducive to Investigational New Drug applications. Engage with us for a seamless and expertly guided journey in the development of your therapeutic innovations.
Experience Matters
Active
Cell/Gene Therapy Clinical Trials
Completed
Cell/Gene Therapy Clinical Trials
What Can We Do for You?
We bring our unparalleled industry insights, specialized knowledge, and established processes to bear on this most important stage of the road to commercialization. We are your guide and partner for testing your life-saving therapeutics in first-in-human clinical trials.
- Scientific advisory resources
- Sophisticated facilities and instrumentation
- Cutting-edge biostatistics and bioinformatics
- Rigorous quality control and quality assurance
- Scientific editing and research communication support
- Thorough toxicology studies
- End-to-end trial design and implementation
- Patient/provider trial recruitment
- Product labelling, distribution, and delivery
- Communications and data management
- Regulatory submissions and NIH compliance
- Research subject protection and patient safety
- Organizational/institutional ethics oversight
- Therapeutic area product level support
- Patient-reported outcome and health economic studies
- Medical information and publications
- Product training
- Medical congress support
- Key opinion leader relationships
- Case logistics
- Case and healthcare provider master data
- Inquiries and complaints
- Medical insurance
- Virtual patient care
- Institutional Review Board submissions and communications
- Research subject protection protocols and planning
- Participant education and informed consent guidance
- Fully accredited by the Association for Accreditation of Human Research Protection Programs (AAHRPP)
We’re all physician-scientists, we work directly with patients, we can answer questions we see in the clinics.
Brian Betts, MD