WIL IT software deal speed up US FDA drug evaluations? Yes says Instem

Regulatory reviewers spend more time managing incoming data than on the drug evaluation process, says Instem which has inked a deal with WIL Research for its nonclinical IT systems.

Preclinical contract research organisation (CRO) WIL has placed an order with IT technology firm Instem for study-related software systems at all its sites worldwide, expanding on an exclusive nonclinical partnership deal struck back in May.
Among the systems WIL has purchased is Instem’s Submit software, used to support the Standard for Exchange of Nonclinical Data (SEND) which is being adopted by the US Food and Drug Administration (FDA) to speed up the development process by providing a vehicle for easier transportation of results of regulatory toxicology studies to regulators.
“FDA reviewers continue to receive mostly paper or electronic paper (PDF) submissions as they evaluate new applications for drugs,” Julie Jones a spokesperson from Instem told Outsourcing-Pharma.com. “They are then manually entering data for further analysis, which is time consuming and inefficient, taking time away from the primary mission of reviewing the content of submissions.”
“Reviewers are actually spending more time manipulating the incoming data than they are on the actual drug evaluation process.”
WIL has also signed up to use Instem’s Provantis trial monitoring tool that allows its toxicology clients to remotely logon to a secure website to view on-going study data.
“Provantis streamlines processes and workflows with straightforward, intuitive functionality for simple and complex studies within GLP or non-GLP environments,” Jones explained.
David Spaight, CEO at WIL Research said: “I’m confident that our expanded technology investment will enrich our research processes, help develop better controls and provide excellent experiences for every one of our clients, while expanding our capabilities for continued growth.”