Vsoft Infoware, Inc. is pleased to announce readiness of Clinfoware® Version 8: A Vision Conceived in 2010, Ready for the Era of Real-Time Clinical Trials (RTCT), with clean data-as-you go suitable for adaptive trials, which was announced by FDA on 28 April 2026.

Vsoft Infoware, Inc., Princeton, NJ 08540

Udison Infoware, Pvt. Ltd., Udupi, Karnataka, India

Clinfoware® Version 8, an integrated eClinical platform based on our patent, granted by GOI patent office, effective November 2010 developed by Vsoft Infoware, Inc., today announced its readiness to support the evolving landscape of RTCT for phase 1 / 2 early phase clinical trial for real time monitoring of safety and efficacy, for next generation of AI ready clinical research based on clean data as-you-go.

The vision behind Clinfoware® originated in 2005, inspired by the objectives of the FDA’s Critical Path Initiative 2004, which highlighted the need for innovation in clinical development, improved data integration, enhanced safety monitoring, and more efficient drug development processes to increase clinical trial success rate. Along with this in 2006, FDA offered 76 opportunities to industry, if implemented, can help speed the development and approval of medical products.  Recognizing these challenges early, the Clinfoware® team embarked on a mission to create a comprehensive and integrated eClinical platform, by filing Patent in October/November 2010, capable of transforming the way clinical trials are conducted and managed to increase the success rate, which was 10% in 2010 and now in 2026 come down further to 8%.

At the time Clinfoware® was conceived, the clinical research industry largely relied on fragmented silo-based systems to manage different aspects of clinical trials and were frequently managed through separate applications from multiple vendors and support groups.

This fragmented approach often resulted in data silos, duplicated effort, manual reconciliation of information, delayed access to critical data, increased operational complexity, and higher costs for sponsors and research organizations. The lack of seamless integration between systems made it difficult to obtain a unified view of clinical trial progress, patient safety, operational performance, and efficacy trends.

As clinical trials became increasingly complex, these inefficiencies contributed to longer development timelines, higher operational expenses, and delays in bringing potentially life-saving therapies to patients. The industry needed a more integrated and intelligent approach. As a result, FDA announced RTCT on 28 April 2026.

For details, refer response to FDA RTCT RFI – https://www.regulations.gov/comment/FDA-2026-N-4390-0157