Alpha Clinics Support Services

Maximizing CIRM's Impact

The Strategic Allocation Framework (SAF) reflects a refined vision to ensure that CIRM’s investments are aligned with its mission.

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Photo Credit: Elena Zhukova of UCLA

The CIRM Alpha Clinics Network offers premier infrastructure for accelerating the delivery of cell and gene therapies across California. Designed to support researchers and investigators, the network provides specialized clinical trial sites with expertise in regenerative medicine, streamlined regulatory support, access to experienced clinical teams, and robust patient engagement programs. By fostering collaboration between academic institutions, industry partners, and the broader medical community, the Alpha Clinics help translate cutting-edge research into transformative treatments, making California a hub for innovation in cell and gene therapy. See contact information and a list of services offered by each site below.

Alpha Clinic
Contact
Clinical Service
Value to Sponsors
Additional Information
Translational Development Service
Facilitating the transition of clients’ preclinical concepts into clinical practice by leveraging City of Hope’s robust resources and expertise in drug development, drug manufacturing, regulatory strategies, clinical trial management, and business development.
Contract Research Organization (CRO) Services
The Office of Research Compliance and Quality Improvement (ORCQI) strives to ensure safe, ethical, efficient and high-quality research. QA monitoring of clinical trials and process development services are supported by certified clinical research professionals.
Proteomics and Advanced Clinical Biosystems Research Institute
Improving patient care by advancing and integrating innovations in proteomics, metabolomics and lipidomics and applying them to translational research, clinical diagnostics and drug discovery.
Community Engagement Studio (CES)
The CES helps facilitate community-engaged translational research between academic and community-based researchers.
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IND Services
Supports the translation of innovative research into approved medical products or therapies.
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Regulatory & Grant Preparation
The Institute for Regenerative cures partners with teams of investigators to provide regulatory and grant assistance customized to the needs of individual projects.
Cord Blood for Research
UCBCP provides at cost, non-clinical grade cord blood units (CBUs) to approved stem cell researchers for research pertaining to biology and new clinical uses of stem cells derived from cord blood.
GMP Services
We specialize in manufacturing cell and gene therapy products according to cGMP regulatory standards. Our cleanrooms, quality systems, and expert staff help academic and industry partners move products from “bench to bedside”.
Telehealth Program
Enabling local clinics to leverage provider-to-provider telehealth technology to connect patients and their primary care providers at Federally Qualified Healthcare Centers (FQHCs), Rural Healthcare Centers (RHCs), Indian Health Services (IHS) and other remote healthcare facilities to UC Davis Health specialists.
Data Management Core
Our Alpha Clinic Data Management Core (ADRC) provides comprehensive and flexible audit-ready documentation packages that help you reduce risk and comply with regulations and standards.
Bioinformatics Core
Analysis of genomics, transcriptomics, and epigenomics datasets along with extensive experience in examining bulk, single-cell, and single-molecule datasets.
Advanced Molecular Imaging
Access to pre-clinical and clinical MRI imaging facilities and expertise for in vivo monitoring studies of engrafted stem cells and other cellular therapies in clinical trials and for IND-enabling studies.
CRISPR Competency Hub
Consultation with UC Berkeley/IGI resource hub to develop gene editing strategy for rare hereditary disorders, from ‘research lead’ editor design, pre-clinical potency and specificity of editor candidates through analytical assay development for drug product profiling and release.
Data and Safety Monitoring
Expert consultation on study design and trial oversight, real-time participant eligibility reviews, monitoring and auditing services tailored to trial complexity and investigational agent.
Clinical Research Finance Consultation Services
Support services across the entire clinical research finance continuum, enabling rapid and compliant financial study activation through post-award reconciliation and closeout.
FDA Regulatory Support Consultation
Ensures compliance with applicable regulations, facilitates communication with regulatory bodies like the FDA, and supports the translation of innovative research into approved medical products or therapies.
Clinical Outreach Support Services
Our experienced community and clinical outreach team helps you to design an impactful proposal and increase access of patients of underserved communities through partnerships with health centers and referral sites.
Cell Therapy Program (CTP)
A one-stop solution to advance projects from preclinical development to all phases of clinical trials. Capabilities include product manufacturing, quality control and regulatory services, together with guidance for investigational new drug (IND) application preparation and submission.
North Star Review Board (NSRB)
North Star Review Board provides IRB services focused on protecting participants and serving investigators. Our board members are leaders in ethical review with unmatched experience. As a 501(c)(3) nonprofit, we have no purpose other than our explicit mission.