Anna Argyris

COVID-19 placed significant pressure on the processes and systems used to conduct clinical trials. Despite the disruption, the industry found ways to keep trials going and came together to accelerate trial execution. With vaccinations in the US exceeding 200 million, it is an excellent time to reflect on the changes made by research sites to speed trials during COVID-19 and the long-term implications to clinical research.

The University of Louisville experienced delays like everyone else, but their leaders understood that adapting to change quickly meant transforming their site operations. So the site embraced new technologies, including eRegulatory applications with remote monitoring capabilities. In doing so, they replaced in-person and paper-based approaches with electronic signatures and digital documentation.

The lessons learned, like investing in research site infrastructure and making quick decisions, have proved transformational for the University of Louisville. To help other site leaders thinking of modernizing operations, here are four lessons to drive long-term change.

Lesson #1 - To stay ahead, start ahead; invest in technology infrastructure

Don’t wait until there is a problem to evaluate site operations. Instead, proactively invest in modernizing technology infrastructure to streamline how work gets done.Examples include using laptops instead of desktop computers, eRegulatory instead of paper and binders, and eSignatures instead of wet ink signatures.

To get started, assess processes and consult with research teams to document current workflows. This process makes it easier to identify functions that can be improved with digital solutions. After identifying the right tools and systems to streamline problem areas, plan for change management. Employees, sponsors, and patients need to understand how to use selected technology and get support if needed.

The need for education and understanding also applies to site policies. From work from home to video conferencing, establish policies that are well understood by internal and external teams. While no one can plan for every possibility, sites that invest in modernizing operations and processes are in a better position to navigate unexpected change with speed, efficiency, and confidence.

“We were able to fully leverage the foundation we had in place to meet unique COVID-19 requirements,” said Rachel Sheppard, MBA, CCRA, CCRC, regulatory and clinical director of the clinical trials unit at the University of Louisville. “The University was prepared to manage change because of the time and efforts put into improving how we work.”

Lesson #2 - Make quick, informed decisions; then focus on execution

Reviewing situations, acting quickly, and speeding decision-making can make or break a site during a crisis. The University of Louisville knew they needed to move fast, and during the first weeks of the COVID shutdown, they decided to transition employees offsite over a single weekend.

To support the change, the site relied on digital solutions to enable remote execution of trial processes. As a result, paper approvals, workflows, and signatures are now executed digitally. The shift away from paper allowed many of the University of Louisville’s clinical trials to support decentralized approaches and keep trials on track. The rapid transformation advanced operations at the university, enabling them to meet the needs of a modern-day trial.

“We want to reach more patients in underserved geographic areas,” said Lale Akca, MBA, CCRA, executive director of the clinical trials unit at the University of Louisville. “Enabling decentralized approaches helps improve patient inclusion and diversity, and we’ve seen improvements so far, gaining broader patient participation in trials.”

Lesson #3 - Transparency with sponsors is paramount

During COVID-19, the University of Louisville increased collaboration with sponsors to determine the best course of action on safety and security protocols. Working together, they developed viable plans to secure Personal Protective Equipment (PPE) for all studies.

Sponsors and sites can form partnerships to run clinical trials that alleviate research team and patient burden. Maintaining open lines of communication and finding ways to improve information sharing can strengthen the relationship. Sheppard adds,“When you are transparent, you build trust. Our sponsors know we treat all of them equally and fairly.”

Communication is also critical in determining the technologies that will be used during the study. Discuss with sponsors what their solutions of choice are, along with what systems you are currently using, potential limitations, and best practices. By taking a proactive approach with sponsor communications, the University of Louisville found that they could expand on the capabilities in their current systems to better meet the requirements of an upcoming study.

When discussing operations with sponsors, it is essential to talk about where the technology resides (onsite or in the cloud), the security measures currently in place, and any needs for training. In addition, be transparent about costs and demonstrate financial justification in models that show savings, improved efficiency, and streamlined processes for both sites and sponsors.

Lesson #4 - Evaluate solutions built for research sites

For sites running numerous studies using multiple systems simultaneously, keeping up with processes can prove challenging. Technologies designed specifically for research sites are now available to help standardize processes across studies. These site-centric solutions consider researchers’ specific needs and pain points and help reduce the reliance on paper in trials.

Choose a purpose-built, secure, cloud-based solution that fits your budget and workflow to help drive efficiency and improve compliance. With these systems in place, you can enable monitors with self-service access to regulatory documents and other information such as personnel qualifications and licenses electronically.

Early on, consider the specific requirements you need to meet while conducting trials. For the University of Louisville, the evaluation process mandated a solution that would closely adhere to strict security measures, including where data goes and who can access it.

Another factor for consideration is choosing a system with standard document naming conventions to help quickly identify and search content and minimize errors. Built-in standards help to automate and digitize processes and eliminates manual filing across multiple studies.

Site-centric solutions improve data security and compliance and enable secure, seamless information sharing in trials. This is a significant advancement to the manual processes, like portals, emails, and paper shipments, previously used by sponsors and CROs to share information with sites.

The lessons shared by the University of Louisville can help sites successfully move from manual and paper-based to more connected and efficient trial processes. This shift is accelerating as research sites embrace digital strategies and systems designed to solve the challenges they face every day.

Establishing a solid digital foundation for your research site, like the University of Louisville, allows for more agility during trying times. Sheppard says that although the future is uncertain, she feels the site is prepared to tackle anything that comes its way.

Looking ahead, technology will continue to play a prominent role in enabling new ways of working with partners in studies. As more companies deploy decentralized and hybrid clinical trials, sponsors, sites, and patients will be able to seamlessly share study information and execute much faster than ever before.

, MS, CCRP, director, site solutions at Veeva Systems

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