EPS Corp Offers CluePoints RBQM Solution
EPS Corporation, a Shinjuku-ku, Tokyo-based CRO, has reached an agreement to offer CluePoints’ Risk Based Quality Management (RBQM) solutions to its sponsors. The RBQM tools will complement either new or existing RBM processes through the CluePoints Central Monitoring Platform to allow EPS sponsors drive early risk detection, improve quality and enhance patient safety in clinical trials.
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Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
FDA to Launch National Priority Voucher Program to Speed Drug Reviews for Critical Therapies
June 18th 2025Under the new initiative, companies may receive a voucher enabling FDA review to be shortened from the standard 10–12 months to just 1–2 months following final application submission if the drug addresses US national health priorities.
