“When we move out of the pandemic, the world has to be prepared.”
—Sagar Anisingaraju, Saama
Saama’s Chief Strategy Officer and Others Opine on What Comes After COVID-19
From R&D to commercial operations, PharmaVOICE contributors Carolyn Gretton and Robin Robinson interviewed stakeholders across the healthcare ecosystem to see how pandemic-induced changes will have a long-term effect on our industry.
Saama’s own Chief Strategy Officer, Sagar Anisingaraju, told the authors he believes there is going to be “a data explosion” at clinical sites, and that management of this data will need to change.
“What I mean by data explosion is that both medical personnel as well as clinical data managers will expect and require different paradigms and tools to gain new insights from all these new datasets,” he said. “Unless technology changes are integrated into the workflows, the conventional process cannot handle the demand.”
Mr. Anisingaraju also noted that the FDA is going through “a fundamental shift” as regulators work to speed up reaction time for COVID-19 R&D. “When we move out of the pandemic, the world has to be prepared,” he said. “There will be more electronic verifications, more AI-driven verifications. We are working with several pharma companies to build deep learning AI models that augment, maybe assimilate, and sometimes transform the clinical data manager’s work. All of this needs to be validated and approved. We expect the FDA and other regulatory agencies to quickly adapt.”
