Why CRO Selection Matters
Selecting the right Contract Research Organization is one of the most consequential decisions a research sponsor will make during drug development. The CRO you choose becomes an extension of your team, responsible for generating the safety and efficacy data that will determine whether your candidate advances to clinical trials.
Poor CRO selection can lead to:
- Study delays that push back clinical timelines
- Low-quality data that regulators question or reject
- Unexpected costs from protocol amendments and study repeats
- Lost compounds that might have succeeded with better execution
- Damaged relationships with investors and partners
Conversely, a strong CRO partnership can accelerate development, provide scientific insights that improve your program, and deliver robust data packages that sail through regulatory review.
The Selection Process
A structured selection process helps ensure you evaluate CROs objectively and make decisions based on data rather than assumptions or sales presentations.
Define Your Requirements
Before contacting any CROs, clearly document your study requirements including species, routes of administration, endpoints, timeline constraints, and regulatory pathway. This enables meaningful comparisons.
Create a Long List
Identify 8-12 potential CROs that offer the capabilities you need. Use directories like InVivoLabs, industry contacts, and conference networking to build your list.
Issue RFI/RFP
Send a standardized Request for Information or Proposal to enable apples-to-apples comparison. Include your study synopsis, timeline, and specific questions about capabilities.
Shortlist Candidates
Review responses and narrow to 3-4 finalists based on technical capabilities, experience, pricing, and responsiveness. Quality of the RFP response often predicts quality of the partnership.
Conduct Site Visits
Visit finalist facilities to meet the team, tour the facility, and assess culture fit. Virtual visits are acceptable but in-person is preferred for high-value programs.
Check References
Speak with current and past clients about their experience. Ask specific questions about communication, problem-solving, and data quality.
Make Selection & Negotiate
Select your preferred CRO and negotiate contract terms. Ensure clear expectations around timelines, milestones, communication, and change orders.
Key Evaluation Criteria
Scientific Capabilities
The CRO must have demonstrated expertise in the specific studies you need. Generic preclinical experience isn't enough — look for deep capability in your therapeutic area, animal species, and route of administration.
Regulatory Experience
Has the CRO's work successfully supported IND submissions? Ask about their inspection history and whether any studies have been rejected or questioned by regulators. Experience with your target regulatory pathway (FDA, EMA, etc.) is valuable.
Quality Systems
For GLP studies, robust quality systems are non-negotiable. Evaluate their QA independence, deviation handling, data integrity practices, and audit readiness. Review recent inspection findings if available.
Capacity & Timeline
Can the CRO accommodate your timeline? Understand their current capacity utilization and how they prioritize when demand exceeds capacity. Delays are costly, so realistic timelines matter more than optimistic promises.
Communication & Project Management
How will you stay informed about study progress? Understand their reporting cadence, escalation procedures, and how they handle unexpected findings. A CRO that communicates proactively is invaluable.
Financial Stability
Particularly important for longer studies, financial stability ensures the CRO will be around to complete your work. Ask about ownership structure, recent growth, and major client concentration.
CRO Evaluation Checklist
Use this checklist during your evaluation process. Click items to mark them as reviewed.
Scientific & Technical
Quality & Regulatory
Facility & Operations
Team & Communication
Commercial
Red Flags to Watch For
Certain warning signs during the evaluation process may indicate potential problems:
If they're slow to respond during the sales process, imagine how responsive they'll be once they have your money.
A CRO that promises significantly faster timelines than competitors may be overpromising to win the business.
Quality CROs are proud of their work and happy to connect you with satisfied clients.
Frequent study director changes disrupt continuity and may indicate organizational problems.
While facilities can recover from regulatory issues, recent warning letters warrant careful evaluation.
Experienced CROs can speak specifically about their capabilities. Vagueness may indicate inexperience.
Green Flags That Indicate Quality
Positive indicators that suggest a strong potential partnership:
CROs that ask thoughtful questions and suggest study design improvements demonstrate engagement and expertise.
A CRO that honestly acknowledges what they can't do earns more trust than one that claims to do everything.
Repeat business from major sponsors indicates consistent quality and service.
Training programs, conference attendance, and career development indicate a commitment to quality.
Consistent regulatory compliance over many years demonstrates mature quality systems.
Key Questions to Ask CROs
Use these questions during your evaluation to gather important information:
- How many studies of this type have you conducted in the past 3 years?
- Who would be the study director, and what is their relevant experience?
- Can you share (blinded) examples of similar studies you've completed?
- What specialized equipment or techniques do you use for this work?
- When was your last FDA inspection, and what were the findings?
- How do you handle protocol deviations?
- What is your process for ensuring data integrity?
- How many IND submissions have you supported in the past 2 years?
- What is your current capacity utilization?
- How do you handle competing priorities among clients?
- What reporting will I receive and how frequently?
- How do you communicate unexpected findings or issues?
- Can I speak directly with the study director during the study?
- Can you provide 3 references for similar studies?
- Can I speak with a client whose study had challenges?
- What is your client retention rate?
- What feedback do you receive most frequently from sponsors?
Site Visit Tips
A site visit provides invaluable insight that documents and phone calls cannot. Make the most of your visit:
Before the Visit
- Send an agenda with specific areas you want to see
- Request time with the proposed study director and key staff
- Prepare specific questions based on your RFP review
During the Visit
- Tour animal facilities and assess husbandry quality
- Review sample documentation (protocols, reports)
- Meet multiple team members, not just management
- Observe interactions between staff
- Ask about their biggest recent challenge and how they handled it
After the Visit
- Document observations while fresh
- Follow up on any unanswered questions
- Share impressions with your team
Making the Final Decision
After completing your evaluation, synthesize your findings using a structured approach:
Create a Scorecard
Rate each finalist CRO across your key criteria using a consistent scale. Weight criteria by importance to your specific program. This creates an objective basis for comparison.
Consider Fit
Beyond technical capabilities, consider cultural fit and working relationship. You'll be partnering with this team for months or years. Do they communicate in a way that works for your organization?
Trust Your Instincts
If something feels off despite good metrics, investigate further. Your intuition often picks up on signals that don't appear in formal evaluations.
Plan for Success
Once you've made your selection, invest time in a thorough kick-off meeting to align expectations. Clear communication from the start sets the foundation for a successful partnership.