Select the right CRO and keep your trial on track, compliant, and audit-ready
BioBoston helps life science teams identify, qualify, and oversee CRO partners so you reduce delays, protect data integrity, and meet ICH-GCP expectations throughout your clinical program
- Senior clinical operations and quality oversight expertise
- ICH-GCP focused CRO qualification and governance
- Risk-based approach that prevents avoidable surprises
Flexible support: selection, audits, or ongoing oversight
Who this is for
This service is a fit if
- You’re selecting a CRO for an upcoming trial and want a defensible choice
- You’ve had CRO performance issues before (timelines, quality, communication)
- You need stronger oversight without building a large internal team
- You’re running multicenter or multi-region trials and need consistent execution
- You want CRO documentation and governance that stands up in audits and inspections
What you’ll get
- You will receive a practical CRO partner package such as:
- CRO shortlist aligned to your therapeutic area, geography, and trial stage
- Selection criteria and decision matrix (clear rationale and documentation)
- CRO qualification plan based on risk and trial complexity
- Quality and compliance assessment or audit report with prioritized gaps
- Contract/SOW and quality agreement support (roles, responsibilities, deliverables)
- Governance model for CRO oversight (KPIs, cadence, escalation, reporting)
- Governance mOngoing monitoring option to keep performance aligned through study executionodel for CRO oversight (KPIs, cadence, escalation, reporting)
What we do
Our CRO Selection & Qualification support can include:
- CRO identification, screening, and selection support
- Evaluation of CRO capabilities, resourcing, and relevant trial experience
- Quality system and GCP compliance assessments or audits
- Regulatory compliance review aligned to ICH-GCP, FDA, and EMA expectations
- Risk assessment and mitigation plan (operational, quality, compliance risks)
- Contracting support (deliverables, timelines, change control, communication pathways)
- Ongoing CRO performance monitoring and oversight (KPIs, issue tracking, escalation)
Why BioBoston
- CRO performance problems typically come from unclear expectations, weak governance, and late visibility into risks
We help you select the right partner up front and put a control model in place, so quality and timelines don’t drift, issues are surfaced early, and your program stays inspection-ready
Shortlist + qualification approach
We identify candidates and define the right qualification depth based on risk
Select + oversee
We support contracting and implement governance so performance stays aligned throughout execution
Discovery call
We confirm your trial goals, locations, timelines, and the CRO capabilities you need
How it works
Frequently Asked Questions
Yes. We can perform a qualification assessment/audit and help close gaps before study execution accelerates.
Yes. We can provide ongoing governance, KPI tracking, and issue escalation support.
Yes. We can support selection and oversight across regions based on your trial footprint.