Has the explosion of clinical trial technology made study execution too complex? For clinical research sites meeting and treating patients every day, the burden of managing multiple systems and tools takes time away from high-value activities. This can also weigh heavily on the relationship with sponsors because a site can work across various partners and studies at any given time.

On average, sites use 12 separate technology solutions for each trial.1 Staff end up with countless logins and required training to effectively leverage these trial technologies.

At the same time, sites continue to consolidate, reduce headcount, and juggle more studies and devices across sponsors and protocols. It’s not a surprise that only 5% of sites say that sponsor technology meets their needs “very well.”2 To run more efficient trials, consider the research site experience when designing a study and explore strategies to improve collaboration.

Three strategies to reduce site burden

Improving the site-sponsor relationship can get trials off on the right foot and on a path for success. Here are three ways that sponsors can lay a foundation for effective collaboration with sites.

Streamline execution for sites. Studies have traditionally required one-off point solutions or devices to complete key trial activities, leaving sites with multiple applications to learn, logins and passwords to manage, and portals to track. Sponsors can significantly streamline the investigators' experience by identifying areas that can be consolidated or automated.

Leveraging technology on the same platform can make it easier for sites to master one user interface and access trial documents and data. This platform approach streamlines information exchange by eliminating the need for document hand-offs. It also allows for more unified data and document sharing.

Enable research sites to choose tools. Allowing sites to select their preferred technology for a trial can solidify biopharma companies as a sponsor of choice. By adopting a collaboration solution that can exchange documents with any investigator site file (ISF) or site system, sponsors can work with whatever technology sites prefer. This is a significant differentiator in the competitive market for securing top-performing sites.

Providing sites with this flexibility enables staff to work across sponsors with the same tools and systems they are used to and trained on, driving consistency. Ultimately, giving sites a choice can increase trial efficiency by requiring staff to perform fewer administrative tasks and freeing up time for high-value activities, such as providing patient care.

Automate low-value processes. Through targeted automation, sponsors can achieve information flow across trial partners, processes, and systems. Automation can enable sponsors to accelerate document exchange and reconciliation between eTMF and eISF, distribute safety letters to notify global sites and regulators of adverse events, and enable real-time information on patient status from enrollment through treatment.

Automating document exchange can speed up reconciliation and study close-out. (Source: Veeva)

Automation is key for unlocking greater speed and efficiency, making it easier for sites to execute key trial processes. For sites conducting numerous trials with different partners, automating the flow of information across stakeholders can help significantly streamline operations, improve collaboration, and speed processing. The efficiency gains can help the industry deliver innovations faster.

Building a better foundation for site and sponsor collaboration

Trial technology decisions often consider a sponsor’s business requirements, not interoperability or site-sponsor information exchange. Today's market is filled with sponsor-centered site engagement tools, point solutions, and middleware that require costly integrations and workarounds, such as APIs, to connect with ISF solutions. Rethinking the approach to trial technology selection and site engagement can drive improvements in efficiency, effectiveness, and collaboration.

Sponsors can take this further by bringing sites into the technology conversation and enabling them to choose their preferred technology. Using a solution that can exchange documents with any site system allows investigator staff to work with existing sponsor processes and technology, regardless of the ISF they choose. This provides sites with the flexibility to be truly technology-agnostic.

As an industry, we work every day to innovate and evolve for the benefit of patients. Before adding more technology that can create data silos and disconnected tools, consider strengthening the fundamentals of clinical trial execution.

By focusing on establishing a foundation to streamline clinical information exchange, companies can lower the site burden, improve study quality, and deliver excellent patient care. Together, we can make a strategic effort to drive seamless collaboration for sites and sponsors.

About the Author

Kenny Kong is vice president of strategy for Veeva Site Connect. Kenny has built connected ecosystems with integrated clinical technologies that streamline sponsor-site engagement for the world’s largest biopharmaceutical companies. He also co-founded a federal program that brought Health IT to medically underserved areas across the United States and is an experienced leader in the clinical implementation of technology.

References

1. BioSpace, New CenterWatch Inc. Study Finds That E-Clinical Technologies Are Increasing Investigative Site Work Burden And Performance Inefficiencies, 2016
2. Society for Clinical Research Sites, Impact Assessment of eClinical Technologies and Industry Initiatives on Sites, 2019