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 INDUSTRY NEWS AND PRESS RELEASES |
Calyx Supports Breakthrough Therapy Approvals for Oncology Treatments |
Calyx |
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Calyx Medical Imaging and other eClinical services provide critical support for clinical development programs to deliver much-needed therapies to market
Nottingham, UK – Jan. 19, 2021 — 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 development programs, including over 250 new drug approvals, and we continually leverage that experience as we can 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.
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.
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News and Press Releases |
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Ampio’s Phase I Study for Inhaled Ampion Advances to Completing Enrollment of Covid-19 Patients With Respiratory Distress
Ampio Pharmaceuticals, Inc. (NYSE American: AMPE), a biopharmaceutical
company focused on the advancement of immunology based therapies for
prevalent inflammatory conditions, announced today that its AP-014 Phase
I inhaled Ampion clinical study in COVID-19 patients is proceeding to
full open enrollment following clearance by the Safety Monitoring
Committee (SMC), which found Ampion to be safe and well-tolerated after
reviewing results from the first three treatment groups.
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White Papers |
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Accelerate Your Database Lock Using Clean Patient Optics
Bioclinica
Because a key step towards database lock is obtaining clean data for all patients, the ability to verify that data are clean early accelerates the ability to lock the clinical database. This ultimately shortens the overall study timeline while ensuring the quality of your data. However, this can be challenging when manually reviewing study data, particularly with larger studies.
More info >> |
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Industry Events |
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DIA Europe 2021
15-19 March 2021, VIRTUAL CONFERENCE
DIA Europe is the must-attend event for all life science professionals
working in drug development, from discovery to marketed use. It
encourages open collaboration by bringing together representatives from
the entire spectrum of the life science landscape and facilitating
crucial discussions across several topic tracks: Clinical Development,
Regulatory Strategy, Pharmacovigilance, Value and Access, Health Policy,
and many more.
More info >> |
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