Executive Insights From A China-Based Biotech On Selecting A CRO

By Rob Wright, Chief Editor, Life Science Leader magazine

Coreen Oei, Ph.D. is the SVP of clinical operations and project management at BeiGene. Oei oversees the execution of clinical trials and the development of budgets and project timelines for BeiGene’s clinical portfolio. Prior to joining BeiGene, she spent 10 years at GlaxoSmithKline where her most recent role was VP, Scientific and Clinical Operations in the Virtual Proof of Concept Unit. Oei recently took time out to answer some questions posed to her by Life Science Leader magazine on her approach to selecting a contract research organization (CRO) from the perspective of a China-based biotech.

Life Science Leader (LSL): What quality metrics do you utilize when building collaborations with CROs and why?

Oei: The quality metrics I use when building collaborations with CROs include financial stability and service capability, i.e. capacity and geographic reach. The turnover rate of their staff and the quality of their people are also important attributes to assess.

LSL: What new trends (good and bad) do you see with contract research organizations?

Oei: There has been an increase in pharma-CROs strategic partnerships, especially among the larger pharmaceutical companies and global CROs. These have resulted in a change in relationships between CROs and sponsors and moved from a tactical/transactional model to one more resembling that of an alliance or partnership.

Some biopharma companies prefer to move away from a transactional model to partnering with one or two CROs, as they lack the resources necessary to manage multiple CROs. While big pharma companies benefit from these strategic partnerships, small to mid-sized biopharma companies may be overlooked in favor of bigger strategic clients. Smaller clients may not view these CROs as having enough capacity to provide the necessary attention in light of demands from larger companies. In order to guarantee attention from the big CROs, smaller biopharma companies need to have a sizable pipeline of work to enable these strategic relationships to be effective.

LSL: When selecting a CRO, what role does cost play in the selection process?

Oei: There are several factors that I would consider when selecting a CRO for my company’s studies. Cost is one of them. The other factors include therapeutic expertise, the relevant geographic reach, as well quality and reliability. I would rank cost as being important, but would not consider it as the most critical factor. I would not select the CRO just because it submitted the lowest cost proposal, as that CRO may not have all the attributes necessary for the successful execution of my projects.

LSL: How would you define accessibility and what can CROs do to not only demonstrate accessibility, but execute on being accessible?

Oei: One of the key requirements during the Request for Proposal (RFP) process is having the sponsor’s questions addressed in a comprehensive and timely manner. In addition, I would consider accessibility as my company having visibility with the CRO, as well as the ability to interact with the CRO’s senior management. I would like to determine if there is transparency and trust in the potential partnership, as I am entrusting the execution of my company’s clinical assets to the CRO. Engagement by the CRO’s senior management team helps to ensure that my company is getting the right attention and service.

LSL: Productivity is considered to be a key component for selecting a CRO. What metric do you use to assess and how do you weight this when comparing different sizes of CROs?

Oei: The metrics I use are those which pertain to clinical execution — a CRO’s core competency. These include timelines for study start-up, timelines to reach enrollment goals, and database lock. These metrics relate primarily to timely project execution (on time and on budget) and are critical for accelerated drug development of my company’s clinical stage compounds. Another useful metric is the number of CRO requested change orders, which may be reflective of a misunderstanding of study needs, scope, and complexity by the CRO during the bid process.

LSL: How do you go about assessing reliability for a CRO?

Oei: All the global CROs have well-defined processes and metrics which can be used to assess reliability. Other useful methods include gathering information on the amount of repeat business and obtaining erformance references. Also, a CRO with at least a decade of proven clinical trial experience is a good ndicator that they possess the necessary expertise.

LSL: What tricks or resources have you found to be highly useful in the CRO selection process?

Oei: I have found it extremely helpful to involve the contracts manager as early as possible in the CRO election process. They are often invaluable in the contract negotiation process.

LSL: Based on your experience, what advice would you give to those involved in the CRO selection rocess?

Oei: It is critical to involve as many members of your team as possible in the CRO selection process, specially if you are selecting a CRO for full-service outsourcing. They will have insight and expertise in reas that you may not have functional expertise. Your team’s alignment with the choice of the CRO elected may very well set the tone for an optimal working relationship between the two organizations.

LSL: What could CROs do to make this process easier on you?

Oei: It is always helpful when the CROs provide a proposal that is as comprehensive as possible. The roposal review process is often highly interactive. The CROs should be prepared to turn around queries  the proposal sponsor in a reasonable amount of time.

LSL: What is your approach to evaluating CROs for regulatory compliance?

Oei: I ask the CROs if they have been audited by the FDA and if there were any 483 observations cited. Since CROs also operate in regulatory environments globally, it is also important to ask them if they have been placed on regulatory or clinical hold in countries outside the United States.