Magazine Article | March 4, 2013

CRO Evaluation By The Small-Company Sponsor

Source: Life Science Leader

By Peter Covitz, Ph.D.

Clinical CRO selection is a critical business process that can be daunting for a small company. A number of high-quality vendors offer services, but selection should be predicated upon a systematic evaluation of distinct areas of competency. Vendors will claim superiority in every area, but all firms have strengths and weaknesses. In most cases you will be assembling a team of expert staff from your own organization, independent consultants, and the selected CRO. For a pivotal trial, in particular, it is crucial that all areas are covered by experienced people.

The following categories are useful for organizing the evaluation:

Protocol Design: CROs that are otherwise capable may be weak in this area. Relying entirely on your principal investigator may also be risky; they may have an academic mindset that is inconsistent with regulatory requirements. Consider using specialized consultants if you do not have the in-house staff. For a pivotal trial, the statistical analysis plan, in particular, should be independently reviewed and validated.

Regulatory Affairs: Examine the regulatory experience and geographic footprint of your CRO candidates relative to your intended geographies. Strong U.S. experience may not be transferable to Europe or Asia.

Medical Monitoring: Do not expect the same level of knowledge as your investigators, but credibility in the disease area and good judgment are critical.

Project Management And Team Stability: A strong project manager dedicated to your trial is needed to ensure tasks and resources are stably aligned. Large CROs with large customers may not give your program the attention or stability it deserves, a trade-off that may negate any advantage it has in depth and breadth.

Site Monitoring: Be sure to evaluate the CRA (clinical research associate) team and their approach to site engagement. These are your primary execution representatives in the field, and they have an enormous impact on patient recruitment and data quality.

Data Management And Specialty Services: Ask for a software demonstration, and perform independent due diligence on any third-party vendors. Understand how end user customer support will be handled.

Legal And Contracting: If your CRO will be managing site contracts, evaluate its legal team and contract templates. Clarity about liabilities and indemnities is essential. If you have a strong in-house legal function, you may choose to contract with sites directly.

Cost: As with most purchases, the lowest price may not be the best choice, while the highest price may not be the greatest value.

With these categories defined, the process is as follows:

  • Prepare a detailed RFP and send to 6 to 10 CRO candidates. The clearer you are in the RFP, the better the proposals will be, so spend time on it.
  • Review the bids, and look for anomalies or unexpectedly high or low price components, as these often point to a misunderstanding of requirements.
  • Contact bidders to clarify as needed, and allow them to update their bids.
  • Score the bids in each of the above categories. A simple scoring system of five points per category should suffice.
  • Align the scores with your needs, and weight the categories. If you can fill a capability with resources outside the CRO, then that category is weighted less in the overall score.
  • Select a short list of top-scoring CROs, and invite them to your offices to give an in-person bid defense. The defense is an all-day event. Put every category on the agenda, and be sure to ask clarifying questions and drive conversation with the CRO’s function leads. In parallel you can schedule and conduct your compliance audits at the CRO and partner sites, as the sponsor must verify CRO compliance with all technical, regulatory, and quality requirements, and you should not sign a contract until audits are complete.
  • Negotiate contract terms with at least two providers, and defer the final selection decision until you have draft contracts to compare. Don’t be shy about asking for concessions or inserting performance incentives. The contracting process will help you narrow down to your final choice.

Clinical trials are inherently risky business activities, but with a methodical CRO evaluation process you can minimize the risks and assemble a capable team for your program.