Calyx RIM Successfully Implemented by a Global Market Leading Pharmaceutical Company in FDA’s eCTD 4.0 Pilot Program

Advancements to Calyx RIM prove effective at meeting evolving, global regulatory requirements

Nottingham, England and Billerica, MA – August 8, 2023 – Calyx, the eClinical and regulatory solutions and services provider relied on for solving complex data challenges in clinical research, today announced a major accomplishment in the evolution of its Regulatory Information Management (RIM) system. Calyx has been successfully used by a global market-leading pharmaceutical company to submit key regulatory information to the FDA during its recently completed electronic common technical document (eCTD) 4.0 implementation pilot program.

eCTD 4.0 is a standard format for submitting applications, amendments, supplements, and reports to FDA’s Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER). eCTD 4.0 submission pilots that enable select pharmaceutical companies to evaluate their eCTD 4.0 readiness are being conducted by multiple worldwide regulatory agencies and are crucial to the success of both industry and health authorities alike.

“We worked closely with this leading pharmaceutical company and the FDA during the pilot program to continue advancing Calyx RIM based on ongoing feedback and lessons learned,” said Jo English, Vice President and General Manager, Enterprise Technology, Calyx. “We’re proud that the advancements we’ve made to Calyx RIM enabled this market leading company to succeed during the pilot program and that all of our clients can rely on Calyx RIM as they adopt eCTD 4.0 as part of their global regulatory processes.”

Visit calyx.ai/RIM for more information on Calyx RIM and its compliance with evolving global eCTD 4.0 regulations.