How to build strong technology vendor and CRO partnerships that deliver for patients, sites, and sponsors
Clinical trials, by their nature, are complex initiatives. And, over time they’ve become even more complicated as studies expand and encompass additional end points, sites, countries, cohorts and study methodologies, as well as new technology. These developments drive unique communication and management challenges that necessitate closer collaboration between all parties involved in delivering a trial—the sponsor, the CRO, and multiple technology vendors.
Each participant in the sponsor-CRO-technology vendor ecosystem brings unique strengths to the table and plays an important role. Sponsors provide therapeutic area expertise; CROS deliver clinical operations resources and knowledge; and technology providers provide technical solutions that support data capture and delivery as well as the patient and site journey experience.
Orchestrating these resources effectively is vital to achieving not only expected outcomes, but more effective and productive clinical trials.
All too often, however, we see siloed approaches that diminish success. Why is this?
It’s often assumed that vendors can simply take the study protocol and implement the stipulated requirements. What’s often overlooked is that, while the protocol sets out significant details of the study, it often delivers only two-third to three-quarters of the of the information required to fully configure software.
From my experience delivering eCOA/ePRO systems, there are critical aspects of the study that are not included in the protocol. These missing pieces often include precise ePRO time windows, patient flows from visit-to-visit, and the process for handling missed diaries. They also don’t typically define data lookback periods or notification regimes.
How can we close this information gap and foster greater communication and collaboration from day one.
It starts with a strong foundation built on three pillars:
- A commitment to operating with trust, transparency, and respect
- Openness to taking accountability and solving problems together
- The ability to put agendas aside to support success of the overall team and initiatives
I share a few operational best practices that I’ve experienced for building this foundation and fostering more collaborative clinical trial teams:
Establish strong relational governance – Create a communication and operational framework that ensures transparent information flow, so all partners have a mutual understanding. The framework should also identify the people and resources required to advance objectives and address issues and risk.
Convene a full-team kick off meeting – These sessions should include key representatives from the sponsor, CRO, and technology vendors, including eCOA/ePRO providers. This approach helps to build relationships and allows team members to connect as individuals. In addition, it ensures that key people with the clinical knowledge and data managers are involved to close any knowledge gaps, and provides a forum so that all stakeholders receive the same information at the same time and are aligned from the start.
Provide early designs to support rapid iteration – Producing visuals early in the process helps align all parties around the eventual software design, allowing for iteration and changes before build takes place. We often come to the KOM with visuals to review and iterate in real-time to get to a 100 percent understanding of how best to configure the software for the study. Using a combination of visuals and study specifications aligns understanding. It’s critical for the sponsor and CRO to provide input and review to make certain vendors fully understand study needs and requirements.
Share accountability – Protocols change and studies update. It’s a fact of the industry. Vendors want to flex to accommodate change, and are aware of the business requirements to achieve timelines. The best partnerships appreciate that changes must be made with quality, and following GCP-compliant processes—both of which can add time. Creating an open, honest, and results-oriented relationship between vendors, the CRO and sponsor can go a long way toward ensuring a successful study. This is best enabled where vendors work alongside the sponsor and CRO to deliver together as an integrated team.
Delivering for clinical trials is incredibly fulfilling, as it can quite literally lead to developments that transform and improve lives. Ensuring the success of a clinical trial, however, is a very challenging proposition. Collaboration—which acts as a powerful force multiplier—is the most certain and direct path to success, as no single stakeholder can deliver alone.