In the traditional world of clinical trials, a CRO manages the study while a CDMO handles the manufacturing. This model works — until you apply it to Cell & Gene Therapy (CGT).
And then, it breaks.
Unlike conventional pharma, CGT trials don’t just test a product — they orchestrate a complex, patient-specific supply chain. Every trial is an operational puzzle, involving:
- Site and patient onboarding.
- Time-sensitive vector and drug product manufacturing.
- Coordination with CDMOs that are capacity-constrained.
- Real-time communication between HCPs, supply chain, and manufacturing
In this context, the traditional CRO model — focused mostly on patient recruitment and site coordination — is no longer fit for purpose.
The Problem: Fragmented Ownership, Disrupted Supply
Here’s the common scenario we see:
- A biotech developer partners with a CRO to run their trial.
- The CRO recruits patients, manages sites, and monitors data.
- Meanwhile, the biotech retains full responsibility for manufacturing.
- That manufacturing happens at a CDMO — which is shared with other clients and programmes, including commercial runs, often accompanied by little visibility in terms of available capacity and upside-down supply chain flexibility.
The result? A fragmented model where no one owns the full picture. Timelines fall out of sync. A patient is enrolled, but vector requires manufacturing or shelf life extension, DP slots at the CDMO are unavailable. Critical milestones slip because manufacturing isn’t aligned with clinical Ops!
This isn’t just inefficient. In CGT, it risks trial delays or even failure.
The Missing Piece: Operational Value Chain Oversight
What’s missing isn’t another service provider — it’s end-to-end operational coordination. Biotechs need operationally focused project management that sits above the CRO-CDMO split, connecting all the moving parts:
- Forecasting and scheduling drug product batches in line with patient enrolment.
- Managing CDMO capacity and tech transfer timelines.
- Coordinating site logistics with vector and DP release.
- Anticipating supply chain bottlenecks before they happen.
This function is rarely present in traditional CRO setups. Yet, without it, CGT trials operate in silos — and that’s a risk the industry can no longer afford.
The Future? CDMOs Evolving into Full-Service Partners
Interestingly, the solution may not lie in reinventing the CRO — but in reimagining the role of the CDMO.
Some CDMOs are already moving upstream, offering services that traditionally belonged to CROs:
- Clinical project management and trial coordination
- Patient scheduling platforms integrated with manufacturing readiness
- Strategic partnerships with HCP networks and logistics providers
They’re not just manufacturers anymore — they’re becoming orchestrators of the clinical supply chain. And for biotech developers, this offers an opportunity to build truly integrated partnerships, where timelines, resources, and risks are jointly managed.
What Biotechs Should Do Next
- Don’t default to the traditional model. Assess whether your CRO has visibility into manufacturing — and whether your CDMO understands your clinical timelines.
- Establish true operational ownership. Bring in expertise to coordinate across CRO, CDMO, and internal functions like supply chain, CMC, and MSAT.
- Explore strategic CDMO partnerships. Some CDMOs are evolving rapidly in CGT — and could offer more value than a traditional CRO setup.
- Challenge silos. In CGT ops, product and patient are interdependent. Managing them separately creates systemic risk.
In Summary
CGT trials are not just clinical exercises — they are complex operational endeavours. Success depends not just on patient recruitment or assay validation, but on how well the entire value chain is managed.
Choose partners that offer integrated, operationally aligned support.
How are you approaching this challenge? How happy are you with the CRO services you receive and are you potentially seeing CDMOs step into a larger role in your trials?
I’d love to hear how others are navigating this shift. Please drop me an email at cristian@radix.partners for an informal discussion.
Let’s Work Together
