MedPoint Launches New Study Document Exchange System
MedPoint Communications Inc.
announced that it is launching a new service, the Study Document Exchange (SDX) System. This new service aims to optimize the regulatory document completion process by providing a rapid, centralized platform to support the flow of documents among sites, sponsors and CROs.
The SDX system operates stand-alone or within an ePortal, and provides support for single or multiple studies, a compound development program, or an enterprise-wide drug development pipeline. All downloaded documents are tracked for up-to-the-minute accuracy in reporting, and completed forms can be printed for record-keeping and compliance. The SDX system supports electronic signatures, incorporates security features, adheres to 21 CFR Part 11, and is considered a closed system.
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 Grants Priority Review to Merck’s sBLA for Winrevair After Early Success in ZENITH PAH Trial
July 2nd 2025Merck’s bid to update Winrevair’s label advances with FDA priority review, backed by Phase III ZENITH data showing a 76% reduction in major morbidity and mortality events in patients with pulmonary arterial hypertension.
