Clinical trial sponsors talk about the importance of accessible data for better decision-making.
Data Provides Context and Meaning across the Clinical Trial Spectrum
Three Saama clients, Len Rosenberg from The Leukemia & Lymphoma Society (LLS) and Pritu Sampeur and Karen Mosher from Astex Pharmaceuticals, Inc. talked about the importance of data accessibility at a recent Halloran Town Hall, moderated by Todd Johnson, a Principal Consultant for Halloran Consulting Group. Saama’s Program Management & Customer Success Director, Bhushan Dadia, was also part of the dynamic panel discussion.
While the two client organizations conduct very different clinical trials—LLS runs a complex oncology Master Trial across multiple pharma companies while Astex outsources all of its traditional clinical trial work, both recognize the importance of data for making better, faster decisions.
“Before Saama, we had to do a lot of legwork to understand site performance and other hot button issues,” said Ms. Sampeur. “We needed to bring everything under one umbrella to ensure we had the right information at the right time, and that it was accessible to all relevant parties.”
“Visualizing the information we need in one place helps us make the right decisions,” agreed Dr. Rosenberg. “In a timely fashion, we need to marry precision genomics data with operational data and use them together to manage a very complex program.”
Mr. Dadia, who handles both the LLS and Astex accounts for Saama, said that people come to Saama for three things: speed to insights, scalability, and agility. “Sponsors don’t have time to go checking with different people for information or worry if their data is complete or accurate,” he remarked. “They want a single source of truth that gives them easy access to the specific information they need.”
“At LLS, we also created an executive dashboard,” explained Dr. Rosenberg. “It only contains the four or five things that different business leaders need to see, but it’s really made a big difference.”
After looking at several analytics providers, both LLS and Astex made the decision to collaborate with Saama. “We had thought about doing a pilot, but it made more sense for us to make the commitment right away,” said Ms. Sampeur. “Knowing that each data connection we needed would take its own time gave us the opportunity to finesse the solution as we went along.”
While Astex had a single point for decision-making with regards to system implementation, LLS had to impose radical change on a wide variety of stakeholders. “Our change management was across the entire spectrum of how we operated,” Dr. Rosenberg recalled. “We forced the issue, because we were providing groundbreaking study designs and therapeutics. We knew that people were going to want to join in and if they didn’t do it our way, they wouldn’t be able to receive timely information about new treatments.”
While data access has been a significant advance for both clients, Ms. Sampeur and Dr. Rosenberg both caution sponsors to be realistic and expect things to go slowly in the beginning. “Getting access to the data we needed has been difficult,” admits Ms. Sampeur. “Getting the EDC connection has been fairly straightforward, but access to the CTMS piece and ensuring the correct fields and formats has been challenging. No one has refused, but we’ve had to work through issues with each one of our partners.”
Ms. Mosher, who serves as Sr. Director Clinical Operations at Astex, became a valuable champion to push the CROs along. “When I joined Astex and heard about the analytical program, I volunteered to help out because I understood the benefits of having this data at our fingertips. We’ve presented a persistent, unified front in order to get all our partners aligned.”
Dr. Rosenberg remembered doing several workarounds in the beginning, which were simply part of the process. “If you keep waiting, you’re going to miss out on getting your trials done the way you want them,” he said. “You can’t run a complex program like ours without the integration of data and having it at your fingertips. Now we can turn around treatment decisions in seven days versus weeks, and that’s incredibly important for us.”
Dr. Rosenberg tells pharma companies that it’s better to get started and then keep making improvements. “We meet as a team on a weekly basis for continuous refinement,” he says.
Mr. Dadia added that pharma companies with a clear vision of the problems they want to solve and where they want to be can accomplish their goals. “Saama can get you about 85-90% there right out of the box and then we work with you to customize the last 10%.”
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