By Débora S. Araujo
With the increase in strategic partnerships and alliances between pharmaceutical or biotech clinical study sponsors and contract research organizations (CROs) sweeping the clinical trials industry, study sponsors often see a need to establish formal structures to help guide these relationships. This, many times, will come in the form of a CRO governance structure. And, of course, the need is not only to establish CRO governance but also to make it effective. Although each organization and relationship is unique, there are a few critical rules that can greatly increase the chance that this governance will be effective. Before exploring these rules, let’s review some foundations of CRO governance.
What Is CRO Governance?
At a basic level, CRO governance is a formal structure, a framework that is put in place by a pharmaceutical or biotech clinical study sponsor and a CRO to establish and guide their relationship. At its core, it is generally comprised of processes, roles, shared mission/vision/goals, key performance indicators (KPIs), and a charter document, although these can vary in complexity depending on the organization.
What Is The Purpose Of CRO Governance?
CRO governance is used to help guide the study sponsor’s and CRO’s relationship, along with helping to maximize the partnership and gain efficiencies from the relationship. Although the appearance of this structure can differ depending on the size of the study sponsor and the pipeline, the extent to which the CRO will be used across the pipeline, and other preferences, there are numerous benefits to establishing a CRO governance structure, even for smaller study sponsors.
How To Establish Effective CRO Governance
Knowing what CRO governance is and its purpose, organizations that desire to establish one need to ensure a few rules are in place to increase its chance of effectiveness. Let’s look at six rules to ensure this happens.
1. Don’t Reinvent The Wheel
If the need for CRO governance arises within your organization, reach out to your CRO partner and request any information they may already have to begin discussions on setting up a governance structure. Many CROs already have such structures in place with other study sponsors and can help accelerate the process for establishing one with your organization. They may have standard templates that you can simply modify to fit your organization. The point is, you most likely do not need to reinvent the wheel on this topic, as you can already begin to gain efficiencies by leveraging the governance processes and knowledge of your CRO partner.
2. Form An Initial Task Force
Once you have established the need for a CRO governance structure and begun conversations with your CRO partner on the topic, it is important to bring in a few other key folks within your organization to spearhead this initiative. This task force should be comprised of key people who understand the business, the relationship with the CRO, and the company’s mission, vision, and goals, and they should have knowledge of the role each function plays in the success of a clinical trial and the overall strategic and tactical objectives of the organization. Initially, this may only be one or two people for a smaller organization or four or more for larger organizations. The important thing is to ensure that the people involved in establishing CRO governance have a breadth of knowledge to address the necessary topics and can help identify other key strategic and functional members for the governance structure. This initial task force may also be able to set the preliminary objectives of the governance, which will be helpful in identifying the final governance committee members1 and downstream processes.
3. Set Shared Mission, Vision, And Goals
Similar to a marriage, a CRO governance structure is put in place to bring two very different organizations together to create a unique agreed-upon path for going forward. Although the two organizations continue to be separate entities, they are both agreeing to set a common mission, vision, and goals for their relationship. This also includes agreeing on any shared risks and rewards both parties are willing to have as part of this relationship.
4. Establish Needed Processes
Invest some time in establishing the processes to help guide the governance structure. Some processes that are extremely important are communication, escalations, and which committees or subcommittees should handle various discussions. For example, which committee will handle cross-project status review or shared annual objective setting? Will it all be accomplished by a single committee or can it be better handled by two separate committees – one at an operational level and one at a strategic level? Establishing these processes is crucial for the success of the governance structure.
5. Determine Appropriate KPIs
Although not all success indicators are easily quantifiable in CRO governance, it is important both parties are aligned on which ones will be used for the relationship. As these indicators are reviewed at a strategic level, they should be across projects. Some examples of these are percentage of cross-project milestones delivered on time, CRO negotiated savings on pass-through costs, percentage of projects bid to awarded, percentage of annual objectives achieved and implemented on time, and quality metrics, among any others both parties would like to include at the governance level. It is important to ensure that governance-level metrics are ones that will effectively measure the health of the strategic relationship and will not simply be a replica of the project-level ones.
6. Create A Charter Document
Once there is agreement on the above points, it is time to include them in a charter document. This charter will be the reference document both parties will use to clearly identify and showcase roles and responsibilities, objectives, communication, and escalation processes, frequency of meetings, different committee descriptions, the meeting forums, etc.1 It can also include the agreed-upon mission, vision, goals, KPIs, and metrics if desired by both parties.
Establishing a CRO governance framework is not an easy feat to accomplish, nor is it easy to maintain, as it requires much effort and energy from various members of both parties. However, the benefits of having an effective one in place can help both study sponsors and CROs reap rewards and maximize efficiencies that would not be possible without one.
This topic and similar ones will be discussed at the ClinBiz Summit 2020 taking place on March 24-26, 2020 at the Hyatt Regency in Morristown, New Jersey. Attendees can also attend the ClinBiz Summit 2020 remotely online via the livestream registration option. For more information and to register visit www.clinbizsummit.com.
- Zuklie, K. (2010, September 1). Governance Committees: Considerations for Pharmaceutical and Contract Research Organizations. Retrieved December 8, 2019, from https://www.pharmoutsourcing.com/Featured-Articles/117991-Governance-Committees-Considerations-for-Pharmaceutical-and-Contract-Research-Organizations/.
About The Author:
Débora S. Araujo has 14 years of of experience in the pharmaceutical industry working and consulting for Fortune 500 companies. Her special focus has been on the business aspects of clinical trials including: clinical contracting and financial management, clinical outsourcing and CRO/vendor management, global clinical trial budgeting and forecasting, clinical financial analytics and metrics/KPIs, site budget development and negotiations, fair market value, and global investigator site payments. Araujo’s passion for driving practical change in the industry led her to launch ClinBiz, an online platform where clinical research professionals can stay connected and updated on the latest topics, trends and technologies related to the business aspects of clinical trials.