Press Releases
Calyx Supports Breakthrough Therapy Approvals for Oncology Treatments
Calyx, the eClinical and regulatory solutions and services provider most relied on for solving complex data challenges in clinical research, today announced that its Medical Imaging and other eClinical solutions supported half of the oncology treatments approved by the FDA as Breakthrough Therapies in the past two years.
“We’re very proud that so many global researchers trust us to manage their important clinical trial data, which led to the availability of these much-needed cancer treatments,” said Gavin Nichols, CEO, Calyx. “Calyx has a long history of supporting successful new product development programs, including over 250 new drug approvals, and we continually leverage that experience as we help our clients solve their most complex challenges with innovative technology and scientific expertise.”
A Breakthrough Therapy designation allows the FDA to grant priority review to drug candidates if preliminary clinical trials indicate that the therapy may offer substantial treatment advantages over existing options for patients with serious or life-threatening diseases. Calyx’s Medical Imaging and other eClinical solutions were used in the development of half of the oncology treatments approved as Breakthrough Therapies since 2019.
Calyx’s eClinical solutions include Medical Imaging, Interactive Response Technology, Regulatory Information Management, Clinical Trial Management, and Electronic Data Capture.
Visit Calyx.ai for more information.
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About Calyx
Through innovative eClinical solutions and services, Calyx turns the uncertain into the reliable, helping bring new medical treatments to market faster. With deep expertise in clinical development and more than 25 years of supporting trial sponsors and clinical research organizations (CROs), Calyx harnesses that intelligence and activates its potential to solve complex problems, deliver fast insights, and get new drugs to market every day.
Medical Imaging | IRT | CTMS | EDC | RIM
Take your trials further, faster at calyx.ai, LinkedIn, Twitter, or Facebook.
Media Contact:
Christine Tobin | Christine.Tobin@calyx.ai | +1 (412) 628-8598
