REACH Trial and The Concinnity Company™ Collaborate to Enhance Investigator-Initiated Trial Oversight with Cloud Concinnity®

NASHVILLE, Tenn., Nov. 25, 2025 /PRNewswire/ -- The Concinnity Company™ today announced that the REACH Trial and Coordinating Center (RCC) is using Cloud Concinnity® to strengthen oversight for Data Monitoring Committees (DMCs), steering committees, operations committees, and other academic research committees with the potential to extend efficiencies across Institutional Review Boards (IRBs) and additional teams.

Investigator-initiated trials, conducted by academic researchers, face unique challenges in coordinating diverse oversight bodies, managing sensitive data, and ensuring rigorous regulatory compliance for safety committees and DMCs due to the limited services available to manage this crucial aspect of a clinical trial. Cloud Concinnity provides a secure, Part 11 validated platform that brings structure, automation, and transparency to these processes.

This collaboration is already delivering measurable improvements:

• Reduction in administrative overhead: Automated workflows minimize manual follow-ups and reduce workload for research teams, required to collaborate across multiple committees as well as sites and study partners.
• Improved document control: Version tracking and structured approval processes eliminate confusion over the latest versions.
• Faster decision-making: Pre-templated letters and real-time collaboration accelerate committee recommendations and actions.
• Better security and compliance: Role-based access ensures blinded and unblinded data remain separate while maintaining complete audit trails.
• Scalability: The platform's modular structure allows adoption across additional departments and research programs.

"Our safety and data oversight committees are essential to advancing safe, ethical, and impactful clinical research. A platform that reduces the administrative burden investigators face when running their own clinical trials accelerates decision-making and allows our trial coordinating team to spend more time focusing on what matters most: delivering discoveries that improve patient outcomes." —Alex Hall, DHSc, REACH Trial Co-Principal Investigator and Assistant Professor of Emergency Medicine and Neurosurgery at Emory University School of Medicine

"The REACH trial investigators are at the forefront of academic research. They're setting a benchmark for how investigator-initiated trials and academia can accelerate innovation while maintaining the highest standards of regulatory compliance." — Nancy Falls, CEO, The Concinnity Company

About The Concinnity Company

The Concinnity Company is the creator of Cloud Concinnity, a secure, 21 CFR Part 11 validated process integration and automation platform purpose-built for clinical trial oversight and broadly applicable to any workflow-driven process that requires repeatability, scalability, consistency, and compliance.

Cloud Concinnity automates, orchestrates, and connects complex business processes that span clinical functions. It provides a high degree of no-code configurability, enabling organizations to design flexible workflows for high-level users who must collaborate across functions, complete with regulatory-grade collaboration tools and capabilities.

The result is greater efficiency, speed, transparency and risk mitigation—so treatments can reach patients faster and at lower cost. The Concinnity Company team is dedicated to harnessing the power of process, innovation, and smart technology to create a stronger, healthier world. For more information, visit theconcinnitycompany.com. 

About the REACH Trial

The Rapid Evacuation and Access of Cerebral Hemorrhage (REACH) Trial—sponsored by Emory University—is a medical research study aimed at finding better ways to treat people who have had a specific type of stroke called an intracerebral hemorrhage. The RCC creates the infrastructure and processes to design, conduct, implement, and manage the REACH Trial and Registry across more than 60 sites throughout the United States. For more information about the REACH Trial visit https://clinicaltrials.gov/study/NCT06870812. 

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SOURCE The Concinnity Company