Software services major Cognizant has launched a new Software as a Service (SaaS)-based cloud product to automate and digitise protocol documentation in a clinical trial, the company said in a statement.
The New Jersey and Chennai-based information technology (IT) firm said that the software called Protocol Creator simplifies the production of protocol documents, saving time and ensuring quality through adherence to standards and best practices seen in the industry.
The Protocol Creator has been embedded with medical writing and clinical trial teams to learn and address their challenges while enabling faster submission by making it a structured document, Cognizant said. This helps teams to collaborate, manage review cycles and deadlines, and the final protocol is finally published in machine-readable formats that enables automation, Cognizant added.
“Every extra day spent before a protocol approved is costly for the company and, more importantly, causes a delay in alleviating the condition of a patient who needs that treatment,” said Bhaskar Sambasivan, senior vice-president and global head for life sciences at Cognizant.
He added that the company had re-designed the entire submission process to be digital-first as the old model was never intended for writing clinical protocols. "Not only does it shorten the time to create the protocol and improve its quality, but it also lays a foundation for a fully digital lab and clinical ecosystem that uses automation and artificial intelligence (AI) to improve clinical outcomes,” Sambasivan added.
The Protocol Creator was conceived, validated and developed by Cognizant Accelerator, the company’s product and platform incubator and venture investing division, the company said.
The product is expected to drive efficiency in clinical trial processes, said Patricia Belissa-Mathiot, director at the centre of excellence for clinical operations at Servier, a French pharmaceutical company governed by a non-profit foundation.
Belissa-Mathiot added, “They understand the challenges involved in the creation of a protocol and have created a product that addresses most of the processes’ pain points.”