Paving the Way for FDA’s Real-Time Trials, Trialynx Wins DPHARM Idol Disrupt

Judges from Roche, Sanofi, BMS, and AbbVie recognized Trialynx’s hub-and-spoke single source of truth model, laying the digital foundation for real-time trials.

MINNEAPOLIS, MN, UNITED STATES, September 30, 2026 /EINPresswire.com/ — Trialynx™, the digital infrastructure for launching real-time clinical trials, is bringing a new model to clinical research. Instead of developing studies document by document, Trialynx connects every decision, document and team to a single source of truth at the center of a hub-and-spoke digital model.

That approach earned Trialynx the top honor at the DPHARM Idol Disrupt 2026 competition, where a panel of 12 judges selected the company from six finalists at the 16th annual DPHARM: Disruptive Innovations to Modernize Clinical Research conference in Boston.

This year’s Idol Disrupt judges included leaders from Gilead, Bristol Myers Squibb, Roche, Sanofi, Daiichi Sankyo, Summit Therapeutics, Bayer and AbbVie.

“Trialynx can transform clinical trials by turning fragmented, document-based study design into an intelligent, structured digital workflow that enables faster, better-informed and more efficient trials,” said Ventsislav Dobrev, Global Clinical Integration Lead, Digital Biomarkers at Roche, in DPHARM’s official winner announcement.

The win comes as the U.S. Food and Drug Administration (FDA) pilots real-time clinical trials, yet most trials are still built from documents that sponsors, CROs and sites write and reinterpret independently. The burden continues once trials are underway: more than three in four protocols require a substantial amendment, according to the Tufts Center for the Study of Drug Development, with each amendment potentially taking months and costing a median of more than $500,000 in a Phase III trial.

“The industry and the FDA are moving toward real-time clinical trials, and you cannot run a real-time trial on paper,” said Angie Schwab, Founder and Chief Executive Officer of Trialynx, who has worked on more than 200 clinical trials. “Winning DPHARM Idol Disrupt in front of leaders from some of the world’s largest sponsors tells us the industry is ready to move beyond the documents and into the digital future.”

Built on Decisions, Not Documents

Trialynx starts with decisions instead of documents. Study teams evaluate market opportunities, regulatory requirements, budgets and timelines, then design the study in one shared digital environment. Those decisions become a single source of truth, with artificial intelligence (AI), automation and human review turning them into more than 30 aligned study documents using each organization’s templates.

When a fact changes, including during a mid-study amendment, it is updated once at the hub and flows to every affected document and team. Trialynx’s Impact Explorer™ identifies what is affected, enabling teams to make updates with a click and full audit trail rather than repeating document-by-document rework.

Study information is captured in alignment with the Clinical Data Interchange Standards Consortium (CDISC) Unified Study Definitions Model (USDM) and International Council for Harmonisation (ICH) M11 protocol standard, creating a connected digital foundation for downstream systems and real-time trials.

Proven Across 56 Real-World Studies

Across 56 real-world evidence studies, Trialynx cut the time to a first protocol draft by 94%, from an average of 18 days to about one day, and reduced revision cycles by 75%, from more than four rounds to one.

“Working with Trialynx is a game changer. They enabled us to launch all of our trials weeks ahead of schedule,” said Ramesh Meesala, Chief Executive Officer of Cliniv.

Zero to Digital in 90 Days

“After more than 20 years in clinical research, I can tell you the technology is the easy part,” Schwab said. “The real challenge is change management and helping teams embrace new ways of working together. That is why we created Zero to Digital in 90 Days, a safe place for teams to experiment with digital trials using their own studies, templates and workflows.”

Sponsors and CROs interested in learning more can visit trialynx.io.

About Trialynx

Trialynx™ is the digital infrastructure for launching real-time clinical trials. Founded in 2023 and based in Minnesota, Trialynx guides study teams through study design, turning critical decisions into a single source of truth that keeps documents, teams and plans aligned. Trialynx is the winner of DPHARM Idol Disrupt 2026 and the 2026 SCOPE/TransCelerate Digital Protocol Review Challenge. Learn more at trialynx.io.

Thomas Johnson
Trialynx
+1 571-215-4909
tom.johnson@trialynx.io
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