In this interview, we sit down with Alisha Garibaldi, CEO of Skylight Health Research, to discuss managing clinical research sites, leveraging technology, and the importance of standardization and communication in clinical trials. Alisha shares her experiences and offers valuable advice for site managers and sponsors.
Moe Alsumidaie: How do you advise site managers to optimize operations and leverage tech without overwhelming teams?
Alisha Garibaldi: I focus on leveraging technology in phases, introducing one new solution every few months. This gradual approach prevents overwhelming staff, who already need to manage tech from sponsors. For instance, it was a massive undertaking when we rolled out a Clinical Trial Management System (CTMS) in February. We set a go-live date, cut off access to the old system, and ensured everyone was comfortable with the
new CTMS. This systematic approach helps manage the transition smoothly and allows us to fully leverage the technology’s capabilities. By becoming experts in each system, we can train our team effectively and address any issues that arise. This ensures that we are not just adopting technology for its own sake but truly enhancing our operations.
Moe Alsumidaie: What challenges do you face when rolling out new tech for your staff?
Alisha Garibaldi: The main challenge is becoming an expert in the specific technology. As a small research site network, I’m heavily involved in operations, so I learn the system thoroughly and then train our site as it applies to our situation. This approach helps manage the overwhelming nature of new technology. For instance, with the CTMS rollout, it was crucial to migrate everything over and ensure everyone was comfortable. I stayed heavily involved during the initial weeks to address any issues and help the team leverage all facets of the technology to increase efficiencies. Being the go-to expert, I can provide immediate support and keep the transition moving as smooth as possible. This hands-on involvement is essential for maintaining operational efficiency and ensuring the team is confident using new tools.
Moe Alsumidaie: Why are standardization and a common language essential for sites, and how does Skylight implement these?
Alisha Garibaldi: Standardization and consistency from trial to trial make it easier to integrate sponsor-specific processes. Our systems outlined in SOPs allow us to communicate clearly with sponsors about where to find information. For example, we use consistent platforms for eReg, eSource, and eConsent across trials, which helps when adding new systems or processes. This consistency is crucial for maintaining efficiency and clarity across trials, especially when dealing with multiple technologies introduced with each new study. A standardized approach ensures that our team is familiar with the processes and can quickly adapt to new requirements. This improves our internal operations and enhances our collaboration with sponsors, as they know what to expect from us.
Moe Alsumidaie: What advice do you offer sponsors on how to enhance collaboration with study sites?
Alisha Garibaldi: Communication and outlining expectations are key. Providing a checklist at the start of the startup process helps sites know what to expect and allows for proactive management. For instance, a list of systems and their uses and access roles would greatly aid in managing the various technologies used in a trial. Sponsors increasingly involve sites in conversations to ensure processes work for everyone, which is a positive shift helping to streamline the startup process and drive smoother collaboration. By being transparent and providing clear documentation, sponsors can build stronger relationships with sites and facilitate more effective partnerships.
Moe Alsumidaie: How does Skylight ensure new tools meet site needs without adding complexity?
Alisha Garibaldi: We stay open to new technology while adopting it slowly. We evaluate whether a new tool fills a gap or could become a headache. For example, when we adopted Veeva Site Vault as our eISF, we started with eReg and gradually added features to understand clinical trial workflow and things like digital delegation logs. By integrating technology gradually and involving site leaders in the decision-making process, we ensure that new tools enhance our operations without overwhelming the team. This careful evaluation process allows us to focus on tools that truly add value and improve efficiency and by involving site leaders, we ensure the technology aligns with their needs and enhances their day-to-day operations.
Moe Alsumidaie: What key tech trends will impact research and site operations, and how are you preparing?
Alisha Garibaldi: We’ve already adopted significant tech pieces that enhance our efficiencies, like CTMS and eReg. The next significant advancement might involve AI, although its integration into our operations is still uncertain. While I’m cautious about adopting technology for its own sake, I’m open to exploring how AI can improve efficiencies. It’s about staying informed and being ready to adopt new technologies that genuinely add value to our operations. By keeping a pulse on industry trends and being open to innovation, we can remain competitive and continue to provide high-quality services.
This content is sponsored by Veeva.
Moe Alsumidaie is Chief Editor of The Clinical Trial Vanguard. Moe holds decades of experience in the clinical trials industry. Moe also serves as Head of Research at CliniBiz and Chief Data Scientist at Annex Clinical Corporation.
