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Calyx RIM Successfully Implemented by a Global Market Leading Pharmaceutical Company in FDA's eCTD 4.0 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.
Through innovative eClinical and Regulatory solutions and services, Calyx turns the uncertain into the reliable, helping bring new medical treatments to market reliably. With deep expertise in clinical development and 30 years supporting trial sponsors and clinical research organizations, Calyx harnesses its intelligence and experience to solve complex problems, deliver fast insights, and get new drugs to market every day.
CTMS | EDC | IRT | Medical Imaging | RIM
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