Selecting a CRO

How to Evaluate Clinical Research Organizations (CROs)

Evaluating a Contract Research Organization (CRO) for your clinical project may seem like a daunting task. You may begin with the internal assessment of your research project(s) to determine which activities could be managed in-house and which would be best to be outsourced.

Outsourcing to a CRO can save your company vital time in the trial and development phase of your medical device or pharmaceutical formulation. CROs already possess the necessary resources, tools, and experts required to perform a medical trial, significantly reducing the time it would take to complete a trial in-house. There are also substantial financial savings in hiring a CRO as the cost to keep full-time staff and medical facilities year-round is significant. 

Outsourcing your clinical research studies to a CRO has helped companies reduce their product development costs by as much as 30%.

Check to confirm a mutual understanding of the activities included in each service, as well as any applicable geographical considerations. You should also make sure that the services offered by the CRO are all provided by CRO employees/subsidiaries. Having everything “under one roof” may facilitate project management.

If a CRO also provides pre-clinical testing services and consulting services, this one-stop shopping may help make the entire clinical testing process work more effective and more efficient.

Make sure the CRO has specific experience and expertise in the clinical area. That often translates into program efficiencies for you – procedures, work templates, resource networking, and team training. If the CRO does not have directly related project experience, you might ask for metrics regarding other projects that may be similar in terms of trial design, subject demographics, and medical practice patterns.

Sponsor companies have a variety of organizational cultures and structures. Early stage companies often have a singular focus on the status of their trial and the need to know details regarding trial activities at any given time – they typically want a fast response and creative problem-solving. Established companies may delegate the trial and request only periodic status reports – they may place a higher priority on procedural rigor than speedy response. You should try to match the experience of the CRO with your specific expectations. 

You want to feel comfortable that the CRO is financially strong enough to withstand business downturns while providing appropriate attention to your project.

How long has the CRO been in business? Is their project portfolio sufficiently diversified to mitigate the risks described above? What practices does the CRO utilize to facilitate sound cash flow management?

This is a critical area of inquiry. Understanding the experience and expertise of those who will be leading and working on your clinical research study can make sure you chose the right CRO. You should understand educational and professional backgrounds as well as their training and practice in the specific device or formulation. Do they have sufficient experience and training in Good Clinical Practice to perform assigned project tasks effectively? The stability of the team is also critical so understanding the tenure of the team who will work on your project can help determine the right CRO partner.

Generally, a single point of contact facilitates clearer communication between the client and the CRO. Take the time to meet and talk with the key person(s) who would be working on your project. What is the CRO’s typical format for reporting and monitoring on the project schedule? Does the CRO have a comprehensive checklist of tasks required for clinical trials?

Budgeting the Project

Understanding the details of the cost estimate for the project can help ensure your expectations are met. Did they take sufficient time to review the budget so that you can verify concurrence of assumptions and general plans? How often does the CRO invoice and how well does the invoice format match the budget provided? What sort of ongoing budget reports can the CRO provide?

Because of the uncertainties associated with conducting human clinical trials, many project budgets and schedules may be revised once or more after project initiation. How does the CRO handle this? Are they proactive in identifying and addressing deviations? You may want to get the names of client references you can talk with to get additional data about the CRO’s performance this area.

Track Record of Client Satisfaction

Client satisfaction is important data for evaluation of the CRO’s performance; however, be careful not to base your entire assessment on feedback from only one reference. Does the CRO have a formal method for monitoring client satisfaction across projects? If so, how often is this assessed and what metrics can the CRO provide? We strongly  suggest you get the names of client references you can talk with to get additional feedback about their experience working with this CRO.

CRO infrastructure is essential to support your project requirements so taking a look at staffing, their investigators, their software, and other infrastructure support tools can help you choose the right CRO. Data is a critical output of any CRO. Make you understand how clinical data is maintained and confirm that it is in accordance with 21 CFR Part 11.

Quality assurance is essential to good clinical research practices. Decisions regarding product safety and efficacy are based on the assumption of study and data integrity.

Make sure you find out what methods the CRO uses to implement their services and confirm the quality of their work. A CROs experience working with the FDA or other applicable regulatory authorities is also critical.  The results of any audits by the regulating bodies and their plans of action to remedy any issues or concerns is also important.  Finally, ask about the any additional quality assurance credentials like ISO certifications.