By Stephanie Eid, Halloran Consulting Group, Inc.
During our recent Clinical Operations Executive Breakfast, Sarah Santipadri, associate director, clinical program management, AMAG Pharmaceuticals, hosted a virtual roundtable discussion titled “CRO Partnerships – Promise or Peril?” Sarah shared some insights that have helped AMAG see success in its strategic CRO partnering efforts. The participants generally agreed that overall, strategic CRO partnerships can accelerate timelines, improve efficiencies through consistent processes, enable access to global footprint, and leverage the continuation of corporate knowledge and domain expertise. The level of collaboration required for these benefits involves constant nurturing and engagement as well as mutual widespread investment between both parties. This article highlights some major takeaways on this topic.
What Does An Effective Partnership Look Like?
While most companies strive to benefit from a partnership, every company has its own driver for entering into a partnership with a CRO (or even avoiding one). When a partnership is successful, there is a range of benefits possible for both parties. Some of the hallmarks of an effective partnership that a sponsor company should try to achieve are as follows:
- Dedication and commitment between sponsor and CRO during onboarding and throughout the life cycle of all studies to ensure alignment on expectations and buy-in from the start
- A “one team culture” mindset that facilitates shared goals and aligned strategies, as well as continuous relationship-building opportunities to help foster and reinforce the mindset
- Clearly defined and mapped processes, handoffs, policies, and procedures to facilitate consistent performance and mutual expectations
- Unambiguous roles and responsibilities for execution and oversight that empower team members to assume accountability
- Collaboration in identifying the root cause of potential risks and issues and shared responsibility in developing mitigations and mutually agreed upon solutions
- A culture of transparency, inclusion, and mutual respect that promotes success for both sponsor and CRO
Where To Start
Effective partnerships between sponsors and CROs require clear and open communication and relationship management to form a common vision of partnering and trust. Establishing effective communication from the start can help you move from a tactical vendor relationship to a more strategic operating model with shared goals and united structures and processes. The following recommendations support productive relationship-building:
- Set up the expectations and groundwork of the partnership. A clear and aligned message is critical. It is critical to align on processes for issue resolution and escalation expectations.
- Take the time to understand each other’s business and each company’s values and culture to anticipate how the companies will interact.
- Create a common mission statement to convey a message up and out of the organization.
- Ensure support from senior management and (cross-functional) stakeholder buy in.
- Determine the right amount of governance.
- Provide trainings on systems and processes. Take the time to train and onboard CROs on the actual processes that will be followed within the trial or outside the scope of a trial.
- Conduct a baseline survey to establish how both the sponsor and CRO teams feel about their relationship to date.
How To Maintain An Effective Partnership
The sponsor and CRO relationship plays a big role in the success or failure of the study, so it is essential to build and maintain a good working relationship between the sponsor and CRO. In addition to establishing solid communication lines up front, there are several ways to ensure the relationship is nurtured and maintained.
- Prioritize collaboration and dedication on all ongoing work and time put into the partnership.
- Conduct ongoing surveys to evaluate the status of the relationship and share results with the full team.
- Maintain an open mind and be understanding of the other party’s point of view.
- Try to stay on track. The deliverables are always the ultimate goal, but the mindset and mental health of the team are just as important.
- Update senior management at an agreed-upon frequency.
- Stay flexible and adaptable throughout the process.
How To Choose The Right Partners
Once you’ve aligned on the level of expectations for maintaining an effective CRO partnership, you should determine what the needs of the project/program are and select CROs that best align with those requirements. Below are recommended key criteria to consider when choosing the right CRO partners:
- Services offered: There are many responsibilities that come with running a clinical trial, so it is recommended that you choose a full-service CRO that will be able to cover services such as regulatory affairs, project management, monitoring, data management, logistics, pharmacovigilance, biostatistics, and medical writing.
- Size of the CRO: Depending on the size of your organization and study, looking for the right size CRO that is aligned with your organizational culture, practices, or expertise is crucial. A smaller pharmaceutical or biotech company might need a smaller CRO that can provide adequate and flexible services.
- Experience: Ensuring that your CRO has suitable experience is key. Assess their previously conducted clinical studies that are comparable to the proposed project, how many projects they have conducted, their therapeutic area expertise, and their phase of development experience. The breadth and depth of the CRO’s experience can significantly affect the value of their service.
- Global footprint: Global reach is pertinent in larger clinical studies, so determine if the CRO can handle your global clinical needs in the areas important to your clinical study, i.e., U.S. and ex-U.S.
- Feedback from your internal and external networks: Ask current and former colleagues or industry experts on their previous working experience with the list of CROs you are evaluating. Getting firsthand feedback on quality of work is helpful.
The benefits of engaging in a strategic partnership are vital to a company’s performance and in turn translate to increased resource efficiency, commitment, cost savings, and, ultimately, more successful studies. Partnerships can be made a success by ensuring internal clarity and alignment, conducting engagement with potential partners, and being open to using cohesive experiences. Thoughtful approaches to the initial relationship-building and in ongoing communications will help lead the path to a successful relationship.
About The Author:
Joining Halloran Consulting Group in 2015, Stephanie Eid has over 10 years of experience in clinical operations, clinical development, and project management. She focuses on providing project management and clinical operations support to clients in leading Phase 1-4 trials and is proficient in managing various aspects of clinical trials including protocol development, selection and oversight of CROs and vendors, budget management, timelines, and quality and risk management. Before joining Halloran, Eid worked as a clinical trial manager at Allergan, managing various aspects of the operational execution and delivery of clinical studies including study start-up, selecting and providing oversight of CROs and vendors, study execution, and study close-out activities, in addition to quality support and inspection readiness.