Here are 27 things that your CRO selection checklist should include.
The CRO selection process often seems daunting.
Clinical trials are lengthy and expensive, and you don’t want to feel “stuck” with a CRO who’s a poor match for your study needs, who struggles with quality, or who can’t stick within anticipated timelines & expected budgets.
The right CRO for you is one that is a best match for your individual study needs. While there is no one-size fits all approach, the below items provide a helpful guide to begin.
The right services and expertise for your study needs
- Do the CROs capabilities cover your specific trial needs?
- Does the CRO have experience in your study phase?
- Does the CRO offer an option for decentralized study capabilities and proactive solutions to decentralized clinical trial obstacles?
- How does the CRO work with a proactive approach that keeps your submission in mind from the start?
- Can the CRO create and provide custom SAS programming?
NOTE: During the submission process, the FDA requests programs for ADaM datasets as well as the programs for the efficacy output. When sponsors use proprietary compiled macros rather than custom programming, additional steps must be taken before review by the FDA or other regulatory agencies.
The right team (without any bait & switch techniques)
- Are the study team members highly qualified and experienced within your therapeutic area or indication?
- Does the CRO provide clear communication on how they plan to stay within scope or expand scope only with explicit approval?
- Does the CRO practice transparent pricing, including a detailed explanation of service costs and thorough definition of pass-through costs?
- Does the CRO have an experienced business development staff with excellent and effective communication?
- Does the CRO offer clear escalation paths, including access to director and/or executive level personnel, if needed?
