Press Releases

CHICAGO, October 20th, 2022 – Celegence, a global provider of regulatory affairs services for the life sciences industry, is pleased to announce that Navignostics, a global developer of drug mechanisms designed to identify ideal treatments for cancer patients, has selected Celegence’s CAPTIS™ technology solution to support Performance Evaluation Reports and other PMS documentation in compliance with the In-Vitro Diagnostic Regulation (IVDR).

Navignostics has been working dedicatedly to leverage unique tumor analysis approaches to improve personalized diagnostics for cancer patients. With highly robust and reliable technology and leading data analytics, Navignostics aims to deliver the optimal cancer treatment for each patient and provide services to pharma and biotech partners.

As the EU’s IVDR directives went into effect this year, diagnostic manufacturers are now pressed by the complex literature review and data management activities required to write PMS documentation to remain compliant. Celegence’s CAPTIS™ cloud solution provides integration with literature and safety databases to automate the creation of PMS documentation, such as Performance Evaluation Reports and Post Market Surveillance Reports. The solution also provides report writing and document management capabilities, which help in the creation and ongoing maintenance of various reports.

Punya Abbhi, Chief Operating Officer at Celegence, said: “We are so glad to support Navignostics in the process of EU IVDR PMS documentation. The CAPTIS™ system will create significant time savings for Navignostics’ medical writing process by reducing manual efforts and helping writers organize and analyze data more seamlessly.

“Navignostic’s mission of designing client-oriented personalized solutions resonates with our values. Celegence realizes our client's unique demands, and we aspire to provide efficient planning and cost-effective solutions through our innovative technologies.”

Dr. Stéphane Chevrier, Co-Founder at Navignostics, said: “We are genuinely excited to work with Celegence and use CAPTIS™ for our IVDR documentation, including literature reviews. I believe the CAPTIS™ platform can better support our compliance efforts related to launching and maintaining focused cancer treatments and medications."

If you would like to learn more about how CAPTIS™ can help you and your organization with regulatory compliance, please contact a Celegence representative today at info@celegence.com. Celegence's expert team is also attending the MedTech Summit US on December 6-8, 2022, at the Intercontinental Chicago Magnificent Mile, Chicago, so please come by our stand – 2 if you are in the area.