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.
Gilead Shares Final Data from Phase III MYR301 Trial of Bulevirtide in Chronic Hepatitis Delta Virus
May 7th 2025Long-term results from the study show 90% of patients with chronic HDV who achieved undetectable HDV RNA at 96 weeks of treatment remained undetectable for nearly 2 years post-treatment.
