Before outsourcing a biomarker-driven oncology trial, a VP of Clinical Operations should ask four categories of questions: how the CRO assesses sites for biomarker screening capability (beyond volume), how it manages central lab result notification at the site level, how its EDC is configured for multi-biomarker eligibility workflows, and what documented turnaround time data it holds from prior programs in the relevant tumor type. A CRO with genuine biomarker trial experience answers these questions with specifics — documented data, named lab relationships, concrete workflow examples. A CRO improvising will answer with generalities about oncology expertise.
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Why Do Biomarker Trials Require Different CRO Questions?
Selecting a CRO for a biomarker-driven oncology trial requires a different set of questions than selecting one for a conventional study. The operational infrastructure for biomarker eligibility — site selection criteria, central lab relationships, EDC specifications, screening failure management — is not universal. Some CROs have built genuine capability here. Others manage it through improvisation.
The questions below are designed to surface the difference. They are organized by functional area, with notes on what a strong answer looks like.
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What to Ask About Site Selection and Feasibility
- How do you assess a site’s biomarker screening capability during feasibility — specifically, what do you look for beyond investigator experience?
- Have you worked with the central laboratory we’re proposing? If so, what is your documented experience with their turnaround times for [specific assay type]?
- How do you handle sites that have relevant patient populations but lack on-site biomarker testing infrastructure?
- Can you provide data on screening failure rates in prior biomarker-driven programs in [relevant tumor type]?
What a strong answer looks like: Site feasibility for biomarker programs should go beyond patient volume estimates to include coordinator bandwidth assessment, central lab logistics history, and biopsy scheduling capacity. A CRO should be able to provide screening failure rate benchmarks from comparable programs — if it cannot, it either hasn’t run the programs or hasn’t tracked the data.
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What to Ask About Central Lab Coordination
- How do you manage result notification from the central lab to the site — is it active notification or portal-based?
- What contractual commitments do you hold the central lab to, and how are deviations tracked and escalated?
- How do you handle sample failures — insufficient tumor cellularity, degraded DNA, invalid results — in terms of re-biopsy coordination and enrollment timeline impact?
What a strong answer looks like: Active notification (automated alert to site coordinator) is the operational standard. Portal-based notification, where sites are expected to check a lab portal on their own schedule, is inadequate for competitive enrollment environments. Deviations from SLA commitments should be tracked in a reported metric, not managed as one-off communications.
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What to Ask About EDC and Data Management
- How do you configure EDC for multi-biomarker eligibility workflows — specifically, how are central lab results integrated into the enrollment and randomization workflow?
- Can you show an example of a biomarker data specification you’ve built for a protocol similar to ours?
- How do you handle biomarker data from multiple labs within a single protocol — and what does that look like in the final analysis dataset?
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What to Ask About Startup and Workflow Design
- How early in study startup do you design the biomarker screening workflow — and at what point does the central lab relationship get formalized?
- What does your site initiation training cover specifically for biomarker eligibility procedures?
- How do you manage sites that are slow to act on eligibility results — is there a monitoring or escalation process?
Kyle Hanson, Director of Clinical Operations, Sitero:
“The most common operational mistake is not fully developing tissue logistics prior to FPI, allowing for potential gaps in specimen management and analysis. Lab manuals may be a low priority in fast-moving start-up, which may lead to no real assessment of whether selected sites can actually execute same-day specimen processing or have the freezer capacity and courier relationships required. Specimen issues may lead to screen-fails and delays in patient enrollment — samples that arrive at the central lab hemolyzed, insufficient, or out of stability window. Each failed screen can delay a patient’s eligibility window by two to four weeks. Aggregated across a trial, poor specimen workflow design can add three to six months to enrollment timelines and meaningfully inflate per-patient costs.”
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CRO Evaluation Scorecard: Biomarker Trial Readiness
| Evaluation Area | Evidence of Genuine Capability | Red Flags |
|---|---|---|
| Site selection | Screening failure rate data by tumor type; coordinator bandwidth assessment in feasibility | Volume-only assessment; no prior data available |
| Central lab coordination | Named lab relationships; documented TAT performance data; active notification model | Portal-based result notification; no deviation tracking |
| EDC/data management | Example biomarker data spec; structured multi-assay field design | Adapted generic template; no edit checks on eligibility logic |
| Study startup | Central lab workflow designed before activation; SLAs in contract pre-lock | Workflow “figured out post-activation”; no contractual TAT commitments |
| Screening failure management | Per-site tracking; escalation triggers; root cause analysis | Aggregate reporting only; no site-level visibility |
| RTSM integration | Central lab result gates RTSM enrollment step | Manual eligibility confirmation outside RTSM |
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12 Questions to Ask Before Signing
The full list of recommended questions across all functional areas:
- How do you assess a site’s biomarker screening capability during feasibility?
- Have you worked with our proposed central lab — what are your documented TAT data?
- How do you handle sites with relevant populations but no on-site testing infrastructure?
- Can you provide screening failure rate benchmarks from prior programs in our tumor type?
- How do you manage result notification from the central lab to the site?
- What contractual commitments do you hold the central lab to, and how are deviations tracked?
- How do you handle sample failures in terms of re-biopsy coordination?
- How do you configure EDC for multi-biomarker eligibility and enrollment workflows?
- Can you show an example biomarker data specification from a comparable protocol?
- How early in startup is the biomarker screening workflow designed and the central lab relationship formalized?
- What does your site initiation training cover for biomarker eligibility procedures specifically?
- How do you monitor and escalate when sites are slow to act on eligibility results?
Related Resources
Biomarker-Driven Oncology Trial Design
Oncology CRO Services & Technology
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Frequently Asked Questions
Q: How do you evaluate a CRO’s central lab relationships if you haven’t decided which central lab to use yet?
Ask the CRO which central labs it has the most experience with for your tumor type and assay type, and request documented turnaround time data from those relationships. The depth and specificity of the answer reveals operational history regardless of which lab you ultimately select. A CRO that cannot provide this data has not prioritized central lab performance tracking as a program metric.
Q: Should the CRO manage the central lab contract, or should the sponsor manage it directly?
Either model can work, but the CRO must have authority to enforce operational SLAs — including result notification timelines and deviation escalation — in whatever contract structure is used. A CRO that has no contractual leverage over the central lab’s performance is limited to managing by persuasion, which is insufficient in competitive enrollment environments.
Q: How do you evaluate a CRO’s biomarker trial experience if they can’t share confidential client data?
Ask for anonymized program summaries showing trial design, tumor type, biomarker used, screening failure rate, and enrollment timeline vs. plan. CROs that have run these programs should be able to provide aggregate performance data without disclosing confidential information. Ask also for descriptions of specific operational challenges encountered and how they were resolved — this tests whether the experience is genuine or curated.
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Planning an oncology trial with biomarker-driven eligibility?
Sitero has supported 200+ oncology studies across 67+ countries. Talk to an oncology trial expert to discuss your protocol.
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References
- Sitero. Oncology Program Operational Data. Internal dataset. 200+ oncology studies across 67+ countries. sitero.com/oncology/
- Hanson K. Director of Clinical Operations, Sitero. Expert interview conducted for this article. April 2026.
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