When you’re preparing to outsource part of your research program, choosing the right Contract Research Organization (CRO) can feel overwhelming. The decision impacts your timelines, data quality, and even the ultimate success of your study. To make the process easier, we’ve pulled together answers to the most common questions researchers ask when evaluating CRO partners.
A CRO is a company that provides outsourced research services for the pharmaceutical, biotech, and life sciences industries.
Sponsors turn to CROs because they offer:
Specialized expertise, with in-house sequencing and data analysis experts to assist with producing and interpreting your results.
Access to advanced technology, often at a scale and breadth not possible for smaller organizations.
Improved efficiency for conducting studies, letting you focus on other parts of your research while timely, accurate omics data are generated.
By leveraging a CRO, companies can reduce costs, accelerate timelines, and tap into skills they may not have in-house.
Start with the CRO’s core competencies. Do they have strong experience in your therapeutic area? Have they managed projects similar in scale and complexity to yours?
Review case studies, publications, and client testimonials. A proven track record is one of the strongest predictors of a successful partnership.
Extremely. If your study involves oncology, neurology, or immunology, you’ll want a CRO with direct experience in that field. Therapeutic area knowledge improves study design, ensures regulatory compliance, and helps anticipate potential pitfalls. It can also save you time and money by reducing rework.
It depends on your needs. Large CROs bring global reach, broad infrastructure, and the ability to manage large-scale, multi-site trials.
Smaller, boutique CROs often offer specialized expertise, personalized service, and more flexibility. The right choice depends on your study’s scope, budget, and how much attention you expect from your CRO partner.
A big one. CROs should operate under relevant quality and compliance standards such as GxP, GLP, CLIA, and CAP. They should also adhere to FDA or EMA regulations. Ask about their internal QA/QC processes, audit history, and certifications. Compliance isn’t just a box to check—it ensures your data will withstand regulatory scrutiny.
Technology is a differentiator. Does the CRO have access to cutting-edge platforms such as next-generation sequencing, proteomics, or spatial biology? Do they have integrated bioinformatics capabilities for complex data analysis? Does the CRO have vendor certification? The right tools can elevate your project and give you deeper, more actionable insights.
Clear, consistent communication can make or break your project. Ask about reporting frequency and escalation pathways for any bumps you might hit along the road.
You should also ask whether they assign a dedicated project manager. A CRO that values transparency and collaboration will be easier to work with and will minimize surprises along the way.
CROs typically use fixed-price, full-time equivalent (FTE), or milestone-based pricing models. When comparing bids, make sure you understand what’s included—and what isn’t. Costs like shipping, sample prep, data storage, bioinformatics, or repeat assays can add up. The lowest bid isn’t always the most cost-effective in the long run.
Yes, and you should. Talking to past clients gives you insight into how the CRO actually performs under pressure. It can also help you assess how the CRO has handled projects similar to yours in the past.
If possible, schedule a site visit to evaluate lab quality, staff expertise, and company culture. Seeing operations firsthand can reveal strengths (and red flags) you won’t catch in a proposal.
Focusing only on price. While budget is important, selecting a CRO without considering expertise, communication, and cultural fit can lead to costly mistakes. A successful partnership is built on trust and alignment, not just the bottom line.
Choosing the right CRO is about more than ticking boxes—it’s about finding a partner who understands your science, respects your timelines, and communicates openly. By asking the right questions up front, you’ll be well positioned to build a strong, productive relationship.
👉 Looking for guidance on evaluating CRO partners? Contact our team for a consultation and learn how to make your next study a success.