Clinical Trial Risk Management: ICH E6(R3) and FDA Expectations for RBQM Webinar - Enhanced Risk-Based Monitoring, Data Integrity Standards, and Patient-Centric Compliance ...

The shift to risk-based quality management (RBQM) in clinical trials offers market opportunities in proactive risk strategies, focusing on patient safety and data integrity. Emphasizing digital ...
FierceBiotech

Rethinking Clinical Trial Data in the Era of Decentralization

Despite rapid growth, only 9.2% of DCTs are multiregional and over 80% single-country, indicating challenges in international implementation. 2 With regulatory agencies 4–7 underscoring risk-based ...
Business Wire

REDCap Cloud Launches Next-Generation Clinical Trial Data and Analytics Platform to Power AI-Driven Research

ATLANTIC BEACH, Fla.--(BUSINESS WIRE)--nPhase, Inc., an innovator of cloud-based clinical research technology, today launched REDCap Cloud 2.0, the first industry platform to harmonize real-world ...
Morningstar

EDETEK Launches BioStat.AI: The Industry's First Unified AI Platform for Clinical Data, Biostatistics, and Programming

BioStat.AI is built on the foundation of EDETEK's flagship platforms, CONFORM™ and eClinical, and leverages advanced AI technologies including large language models (LLMs), machine learning, and ...