The problem with how most sponsors choose CROs
Most vendor selection processes follow the same pattern: issue an RFP, receive a stack of responses that all claim therapeutic expertise and operational excellence, shortlist based on brand recognition and pricing, then award the contract to the team that gave the best presentation.
Six months later, enrolment is behind, the project manager has changed twice, and you're discovering that "extensive experience in oncology" meant two Phase 1 trials from four years ago. Industry surveys consistently show that roughly two-thirds of sponsors are dissatisfied with CRO performance on at least one major metric. The selection process itself is partly to blame.
Here's a structured checklist — not theoretical, but built from the patterns that separate vendors who deliver from those who just sell well.
Therapeutic-area track record (not just claims)
Ask for the number of trials they've run in your specific indication and phase in the last three years, not lifetime totals. A CRO that did 40 oncology trials in 2018–2020 but only two since 2023 may have lost key staff and investigator relationships. Recent, relevant experience is what matters.
Enrolment performance data
Request actual versus planned enrolment numbers for their last five studies in your therapeutic area. If a CRO won't share this, that's a signal. Vendors who consistently meet or exceed enrolment targets are usually willing to prove it. Those who don't will redirect the conversation to capabilities.
Team continuity guarantees
Who is actually running your trial? The bid team and the delivery team are often different people. Ask for named CVs of the project manager, clinical lead, and biostatistician who will be assigned to your study. Get team-change commitments in the contract — with cost implications if key personnel leave mid-study.
Geographic footprint vs. patient access
Offices in 40 countries sounds impressive, but what you need is site presence where your patients actually are. Ask for site-level enrolment data in the geographies you're targeting. A CRO with deep relationships at 15 high-enrolling sites in your target region beats one with 200 sites that each enrolled two patients.
Data quality and query resolution metrics
Query rates tell you how clean the data is going into your database. Ask for their average query age (time from query to resolution) and query volume per data point. High query rates indicate either poor site training or inadequate monitoring — both of which cost you time and money downstream.
Technology stack compatibility
What EDC, CTMS, and IWRS/IRT systems do they use, and can they integrate with yours? Technology mismatches are a silent cost driver. If your sponsor systems and the CRO's systems can't communicate, you'll pay for manual workarounds and double data entry. Get a systems map early.
Subcontracting transparency
Many CROs subcontract significant portions of work — central labs, imaging, data management — without making that clear in the bid. Ask directly: what percentage of the scope will be subcontracted, to whom, and who holds the relationship? You're evaluating the CRO, not their unnamed downstream vendors.
Regulatory and inspection history
Check for recent FDA, EMA, or MHRA inspection findings. A clean inspection history isn't remarkable — it's expected. But inspection findings, warning letters, or voluntary actions in the last three years should prompt direct conversation. This is public information, and any hesitation to discuss it is a red flag.
Pricing structure clarity
The lowest bid isn't always the cheapest outcome. Look for: unit pricing versus fixed fee, how change orders are handled, what happens if enrolment targets change, and whether pass-through costs (travel, investigator grants, lab kits) are included or extra. A transparent pricing model with clear assumptions beats a low headline number with vague terms.
Communication and governance model
How often will you get status reports? What's the escalation path? Who is your single point of accountability? The governance model should be specified before contract, not negotiated after things go wrong. Weekly operational calls, monthly steering committees, and a named escalation contact are table stakes for any study above Phase 1.
References from similar studies
Not curated testimonials — actual references from sponsors who ran studies of similar size, phase, and therapeutic area within the last two years. Ask the references about delivery timeliness, budget adherence, and whether they'd use the CRO again. If a vendor can't provide three relevant references, that tells you something.
Exit and transition provisions
Nobody plans to switch CROs mid-study, but it happens more often than anyone likes to admit. Your contract should include clear transition obligations: data handover timelines, document transfer, site communication responsibilities, and minimum notice periods. The time to negotiate exit terms is before you sign, not when the relationship is already broken.
Using this checklist
Not every point will carry equal weight for every study. A Phase 1 first-in-human trial in a single site has different priorities than a global Phase 3 cardiovascular outcomes study. But the principle is the same: evaluate evidence, not promises.
If you're comparing multiple CROs, score each one against these twelve points before you look at the pricing page. You'll find that the vendors who score well here are almost never the cheapest — but they're consistently the ones who deliver on time, on budget, and without the mid-study crises that drain sponsor resources.
Clinical Vendor Compare exists to make this kind of evidence-based comparison easier. We aggregate performance signals, review data, and therapeutic-area depth across the vendor landscape so you can shortlist with confidence before you ever issue an RFP.
Start with evidence. Compare vendors across therapeutic areas and performance metrics.
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