By Erin Harris, Editor-In-Chief, Cell & Gene
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When it comes to partnering with a contract research organization (CRO), many pharmaceutical and biotech companies, particularly small ones, have no choice but to outsource. From crafting clearly defined policies and procedures to establishing non-negotiable requirements of a CRO partner, Sponsors select CROs meticulously and judiciously. I caught up with Bob Paccasassi, VP of Quality and Compliance operations, and Mandy Clyde, VP of Operations at BioRestorative Therapies for their insight on the best strategies for partnering with a CRO. Here’s what they had to say.
- When selecting a CRO, who within the company is involved in the decision making, and why?
Paccasassi: BioRestorative implements a cross-functional review during our CRO selection process. Beginning with initial discussions and RFP development through to bid defense activities and final selection, all internal management personnel (as well as persons with external clinical operations expertise) are brought to the table and critical input is solicited. In a smaller organization such as ours, there is limited value in building a silo approach around the CRO selection process. Everyone is tapped to provide key insight — from their functional standpoint, knowledge and previous experience — on any number of criteria including cost, capability and timing to determine whether the CRO candidate is a solid fit.
- What are your non-negotiable requirements of a CRO partner?
Clyde: Of substantial importance is the ability to understand our strategic approach toward the project and our critical needs and expectations. Functional expertise in areas wherein we have limited in-house resources is one key expectation. A willingness to work as a partner with our company rather than simply be a supplier of clinical services and personnel is another. A true understanding of and desire to work toward success with regard to the entirety of the project is a principal need.
- What does the CRO expect of your company when establishing a partnership?
Paccasassi: I would think, with smaller companies that may not have fully developed systems and processes in place, transparency and a willingness to work together as stakeholders in the success of the clinical trial is beneficial and expected. Realistic approaches to the clinical protocol and executable timelines have to be developed. Input from your CRO will be of great benefit if you are willing to listen and consider with an open mind. The reason you are bringing in external expertise and resources is because you may not have such capabilities within your current organization or, if in place, such resources may be better utilized in other capacities. Further, a CRO likely expects open communication with a Sponsor as it is critical that in-house and external clinical operation teams are aware of all existing or new developments that may affect the project plan, in a timely and effective fashion, for any successful Sponsor/CRO relationship.
- What are some of the biggest challenges associated with selecting a CRO?
Clyde: One of the biggest challenges we faced was gaining a common and complete understanding of what can or cannot be provided by a potentially selected CRO. Ability and experience vary from one CRO to the next and adding to the scope of work may not always be possible if these additional activities are not part of the contracted CRO’s area of expertise. There may be some activities your organization will wish to manage as part of the project while other responsibilities will be transferred to the CRO. Regardless of whether you are working with a small CRO or an industry leader, it is important to understand the division of responsibilities early in the process.
- How do you overcome these challenges?
Paccasassi: Transparency and a willingness to work in concert with your CRO from early on is key. Clear lines of communication on all issues need to be in place and clearly defined. Assure that all responsibilities are spelled out in some form of Responsibility Matrix and note that where inconsistencies or questions exist, they are clarified and answered early on.
- What would our readers be surprised to learn about the partnership between the CRO and the company?
Clyde: To use an old saying, “It takes two to tango.” Often, the assumption is that you hire a CRO, provide the scope of work, pay the running costs, and they are on their own. You, as a Sponsor, need to work equally as hard at supporting the CRO’s activities as they will be supporting your clinical trial. Remember that both the Sponsor and CRO must function as active partners toward the success of any clinical program. No one should ever be working in a silo when your clinical trial is at stake.
- What advice do you have for biotechs when it comes to selecting and partnering with a CRO?
Paccasassi: Take the time to fully scout out your options; the largest, most well-known CRO isn’t necessarily the best fit for every trial. Use the start of the sourcing process through bid defense, and finally approval of your service agreement, to decide if the CRO is right for you. Provide small projects to the CRO up front before signing off on the contract, and see how they perform. This can help give you a snapshot of their proficiency. Are you finding a slow response time or maybe a less than clear pathway within their internal processes to address your needs? Is there is a lack of clarity on who will be your contact in a certain key area? Companies often look at cost and timing but should think more about the entire Sponsor/CRO relationship. How the CRO interacts with those in your organization and how easily and effectively your company and your CRO interact will make for a much more successful (and pleasant) clinical trial process.