Cognizant Digitally Transforms the Clinical Trial Protocol Process

Cognizant has introduced Cognizant Protocol Creator, a SaaS collaboration product that automates the development of clinical trial protocol documentation. A first for the life sciences industry, Protocol Creator enables clinical teams to create and review protocol documentation in a purpose-built collaborative environment. The software simplifies the production of protocol documents saving time and ensuring quality through the adherence to industry standards and best practices.

Taking a design-thinking approach to the development of Protocol Creator, Cognizant embedded itself with medical writing and clinical trial teams to learn about and address their challenges. With a goal of getting a protocol to submission faster, Protocol Creator generates clinical trial documentation as a structured document. It helps teams collaborate, manage review cycles and deadlines, and enables the final protocol to be published as a traditional document or in machine-readable formats that lay the foundation for downstream automation.

“The development of the protocol document is a long standing target for driving efficiency in our clinical trial processes,” said Patricia Belissa-Mathiot, Director Center of Excellence Clinical Operations at Servier, an international and independent pharmaceutical company, governed by a non-profit foundation, headquartered in France. “Cognizant understands the challenges involved in the creation of a protocol and has created a product that addresses most of the processes’ pain points, improve the ways of working and offers some future opportunities for downstream activities. It has been exciting to be part of the journey that has led to the launch of Protocol Creator.”

“Bringing a single new treatment to market today costs more than a billion dollars. Every extra day spent before a protocol is 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 & Global Head, Life Sciences, Cognizant. “Cognizant Protocol Creator redesigns the entire submission process to be digital first as opposed to one built around antiquated systems that were never intended for writing clinical protocols. Not only does it shorten the time to create the protocol and improve its quality, it lays a foundation for a fully digital lab & clinical eco-system that uses automation and artificial intelligence to improve clinical outcomes.”

Cognizant Protocol Creator is the latest Life Sciences product conceived, validated and developed by Cognizant Accelerator to reach general availability. Cognizant Accelerator, the company’s product and platform incubator and venture investing division, worked with Cognizant Life Sciences to bring Protocol Creator to the market.

“We are firmly focused on delivering transformational products that adopt digital technologies to drive efficiencies throughout an organization,” said Todd Paoletti, Vice President and General Manager, Cognizant Accelerator. “Cognizant Protocol Creator demonstrates this focus, as it plugs a gap in the clinical trial lifecycle that has been, to date, ignored by most technology vendors. With Protocol Creator, we’re underscoring our commitment to the life sciences industry as a service and product provider.”