Former CRA Turned Pharma Exec Provides Insights On Selecting A CRO

By Rob Wright, Chief Editor, Life Science Leader magazine

Marc Tokars is the Sr. Director of Clinical Operations for Luitpold Pharmaceuticals, a manufacturer of branded and generic pharmaceutical products. Tokars has over 20 years of tenure in the pharmaceutical industry and has been involved in the development of regulatory strategies, clinical trial design, trial conduct, and outsourcing. Having functioned as a CRA (clinical research associate) with Sanofi-Aventis, project manager with Covance, and project director with Omnicare Clinical Research, Tokars has a unique perspective on the CRO selection process from the pharmaceutical side of the business, given his diversity of experience having worked on the CRO side of the business for nearly half of his career. Life Science Leader magazine posed a series of questions to Tokars to get his insights on key issues to consider during the CRO selection process.

Life Science Leader (LSL): When selecting a CRO, what role does cost play in the selection process?
Tokars: For smaller companies, start-ups, or even small to mid-size pharmaceutical companies, the unfortunate truth is that cost is a major consideration when selecting a CRO. There is just no getting around it. Our company is fortunate to have a small, dedicated, core team that not only manages the CRO’s overall activities, but actually works along with the CRO’s staff. Contracted tasks such as site selection, contracting, monitoring, site payments, and data review are usually not solely the responsibility of either the CRO or the sponsor, but often, these are shared based upon resources. As a sponsor, this not only provides a cost savings, as the sharing of tasks reduces the CRO’s workload, but also allows the sponsor a greater understanding of the challenges posed by the particular trial and faster input into their resolution. Unfortunately, for various reasons, some CROs seem reluctant to fully enter into this type of relationship or fail to pass on the full savings incurred to the sponsor.

LSL: Accessibility has been listed as an important component in the CRO selection process. How do you define accessibility and what can CROs do to not only demonstrate accessibility, but execute on being accessible?
Tokars: In my mind, accessibility is not simply ensuring that the CRO staff assigned to your project be available for a teleconference or meetings to present suggested solutions to project challenges, but instead, need to be a true partner, allowing the sponsor transparency into CRO thought processes and internal deliberations. Talking through the challenges, the history, and potential future remedies with a higher-level expert, often not intimately involved in the day-to day operations of the trial, provides a 360° review of the problem and potential solutions. In this way, the best solution is often discovered.

LSL: Productivity is considered to be a key component for selecting a CRO. What metric do you use to assess and how to you weight this when comparing different sizes of CROs?
Tokars: Integrating our staff into the CRO teams provides a number of benefits. One benefit is the easy assessment of the CRO’s productivity. The bar becomes very reasonable. Can the CRO staff perform the same tasks as fast and as well as our internal staff? Site monitoring is the most telling and often the easiest to evaluate via this method. Our team is able to observe if the CRO’s monitors provide the same level of oversight, clean data, and protocol compliance as what we would strive for internally.

LSL: Based on your experience, what advice would you give to those involved in the CRO selection process?
Tokars: The CRO you ultimately choose is really only as good as the team currently dedicated to your project. Large or small, CROs are a collection of people that range in ability, experience, and most importantly work ethic. I recommend, if possible, start small. Give a new CRO a smaller, less critical project and evaluate their performance. If satisfied, place subsequent larger trials with the same company ensuring to the best of your ability that key performers are again assigned to your project. Make sure your internal team works to build trust and cooperation with the CRO staff. If fortunate and able to utilize the same, or mostly the same, CRO resources on multiple projects, you will likely find that the CRO staff develops a sense of ownership for the development program. This in and of itself increases the quality and performance of the contracted staff.

LSL: What are some of the frustrations you have had in going through the CRO selection process?
Tokars: The greatest frustration we often encounter during the CRO selection period centers around inflexibility. Comparing different CROs for a single project can prove difficult, especially when requesting costs for services in specific formats and breakdowns. Business development groups, almost stubbornly, try to fit their cost algorithms into our preferred formats and often fail miserably, adding error into the estimates. Inflexibility in what services CROs may not want to share with the team also adds a great deal of complexity to the process, as realistically estimating the costs for the shared task proves difficult for some CROs.