Regenerative Medicine & Advanced Therapies Clinical CRO
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Therapeutic Expertise //
Regenerative Medicine
When you need a hands-on partner for complex cell, gene & RM trials
We support pharmaceutical, biotech and device sponsors running cell, gene and regenerative medicine (RM) studies that demand surgical site readiness, chain-of-identity controls, cold-chain logistics and rapid, compliant execution. Our model pairs senior oversight with high-touch site support across autologous and allogeneic programs from first-in-human through Phase III.
PRC Clinical is the specialized clinical CRO for small-to-midsize RM programs that need precision, continuity and direct access to decision-makers.
Key Scope & Footprint
Phases:
FIH/Phase I → Phase II/III
Models:
Full-Service or Modular
Trial settings: hospital, surgical suites, interventional radiology, specialty endocrine/neurology centers
Cell & Gene Modalities We Manage
- Cell therapies: autologous & allogeneic MSCs, iPSC-derived cells, tissue-specific cell products
- Gene-enabled/adjacent: AAV-based protocols, gene-modified cells, supportive biologics
- RM combinations: drug-device and procedure-assisted delivery (e.g., implantable pouches, scaffolds)
Administration & Delivery Expertise
- Intrathecal, Intradiscal, Subretinal, Stereotactic CNS, IV/infusion, Implantation/biologic device
- Surgical/procedural SOPs, dry runs and/or coordination with real-time dosing oversight
Product Logistics & Traceability
- Chain-of-identity/chain-of-custody planning and verification
- Cold-chain timing windows, dose prep checklist and on-site reconciliation
- Product accountability integrated with AE/SUSAR workflows and dosing time stamps
Regulatory & Quality Infrastructure
- IND/CTA support and CMC interface (with sponsor & manufacturer)
- Unblinded monitoring for dose verification; deviation escalation & CAPA
- Long-term safety follow-up design and retention plans for rare/specialty populations
What Sets PRC Clinical Apart
Surgical Site Activation — Done Right
We qualify and train procedural sites (neurosurgery, ophthalmology, spine, interventional) and run protocol-specific simulations so first-dose days are predictable, compliant and safe.
Logistics You Can Trust
Time-critical handoffs are mapped into the visit schedule. We align manufacturing windows with patient readiness, minimize idle product risk and document every step for inspection readiness.
Adaptive Execution Without Losing Time
We routinely integrate mid-study protocol amendments (new dose cohorts, revised immunosuppression, updated eligibility) while protecting timeline and data integrity.
Senior, Accessible Leadership
You’ll work directly with decision-makers who’ve delivered cell, gene and RM programs end to end—no extra layers, no slow handoffs.
Selected Case Experience
(Representative, De-Identified)
Allogeneic Cell Therapy, Spine (Intradiscal):
Full clinical ops including surgical site training, product accountability and real-time safety oversight for chronic low back pain; maintained chain-of-identity across multisite U.S. network.
Umbilical-Derived Cell Infusions, Respiratory Indication:
Coordinated short-window infusion logistics across hospitals; aligned dosing, accountability and AE signal detection with central safety.
Centrally Acting Non-Opioid Analgesic (Neuropathic Cancer Pain):
PRC oversaw multisite trial operations for a repurposed non-opioid agent targeting NMDA pathways in cancer-related neuropathy. Our team managed complex safety oversight, rescue medication integration and high-risk patient populations.
Gene Therapy With Stereotactic CNS Delivery:
OR workflow design, unblinded monitoring, and intra-op product handling; long-term follow-up management and retention tools; inspection-ready documentation.
T1D Endocrine Network Experience:
Operations with leading diabetes centers and foundations (site engagement, C-peptide/MTT workflows, immune monitoring), relevant to RM programs requiring specialized centers and multi-stakeholder alignment.
Whether you need full service or targeted support (feasibility, site startup, monitoring, unblinded oversight, safety,or long-term follow-up), we tailor resourcing to your study’s risk, phase and delivery complexity — and we stay responsive as the protocol evolves.
Let’s talk — Schedule a pre-RFP consultation to discuss timelines, sites and delivery logistics for your RM study.
