By Brion Regan, Product Manager, Insights Cloud, ERT
The typical relationship between clinical trial sponsors and CROs is rarely described as ‘simple.’ And few, if any, are based on the trust and collaboration that would improve efficiencies in clinical research.
With over 70% of clinical trials being outsourced to CROs, and less than 10% meeting trial completion dates, the question becomes not when, but how can this critical relationship be improved to make clinical development more efficient?
A crucial part of the answer lies in technology - both the wider application of existing technology and the development of new technologies.
By leveraging advanced data oversight and collaborative technologies, sponsors and CROs can share and explore data in ways they never could before. They also have the ability to monitor and manage risks across the entire site network and to build-in custom triggers and reports to address the unique goals and risks for each project.
To make the most of these new technology platforms, sponsors and CROs also need to re-frame the way they work together. Relationships based on trust, transparency, flexibility and accountability will contribute to meeting their shared data quality and trial efficiency goals.
Here’s how next generation clinical risk management technology enables them to do so:
1. Be transparent. New platforms will enable sponsors and CROs to see all of the data from every site and to make real-time decisions based on progress and risks. However, it only works if both parties trust each other to review all the data and to work together to identify and address issues that arise.
This requires a collaborative approach to data management, in which sponsors and CROs work together from the planning stages of the program to establish clear data sharing strategies. This includes identifying how risks are identified and how they will be addressed using pre-defined mitigation plans.
To achieve this, sponsors and CROs agree on the technology platforms used to create a shared view of the data and define how that data will be used to support desired project outcomes. Using data to support decision-making builds a foundation of trust and provides a baseline that both teams can refer back to if conflict occurs.
2. Hold each other accountable. Accountability is the key to a successful collaboration. It is achieved by jointly defining expectations for the project from the beginning, including site selection criteria, frequency of site visits, data capture processes and cadence of workflows. This planning process will also define each party’s roles and responsibilities along with a tracking system to determine whether tasks are performed and to what degree of success.
It takes commitment from both sides. New technology tracks and provides shared visibility into key performance indicators to ensure thresholds are being met and each party is living up to its commitment of achieving project goals.
Having equal access to performance metrics enables accountability and eliminates the wasted time and noise that occurs when tasks fall through the cracks.
3. Be flexible, and let the data guide your way. Having equal access to key performance metrics and trial trends enables both parties to streamline the workflow and adapt the project plan as the data dictate.
Next-generation clinical risk management technology will enable sponsors and CROs to be flexible so that they can respond to trial trends and move ahead quickly, with confidence.
It’s not easy to shift from a contract-driven vendor relationship to a strategic partnership where CROs and sponsors operate as a team from planning through implementation of the clinical research program.
Technology will enable success, but it is the combination of robust technology and collaborative relationships that drive better, faster results with fewer errors and less time wasted.
When sponsors and CROs find that intersection between technology and simplified relationships they will derive the greatest benefits from these platforms.