Berliner Tageszeitung - Florence Announces AI-Assisted Workflows to Transform Clinical Trials

Built in collaboration with top sponsors, CRO partners, and hundreds of research sites; these new Human-in-loop (HITL) AI capabilities are built to supercharge clinical trial professionals as they tackle some of the most persistent challenges in the industry:

• Limited Visibility Into Site Performance: Sponsors struggle to identify the right research sites, relying on disparate and stagnant data sources that provide limited visibility into true site capacity and performance.

• Inefficient Study Start-Up Processes: Timelines are bogged down by manual and fragmented workflows and communication across stakeholders. Meaning critical data and documents are trapped in email chains, portals, and spreadsheets- causing version control issues, compliance risks, and inefficiencies.

• Fragmented Oversight & Monitoring: Fragmented data and documents means that sponsor oversight is limited. Disparate systems prevent monitors from having real-time visibility into trial progress. As a consequence, costly physical site visits are still needed.

AI Assisted workflows will be available to Sponsors, CROs and Research Sites in October 2025

Florence Healthcare will introduce modules to directly address the challenges listed above. These will include:

• Site Identification & Feasibility: Utilizing these new workflows, Sponsors will be able to quickly search across site profiles according to therapeutic area, geography, and real-time performance criteria to pick the right sites for study startup. From there they can deliver protocol-specific feasibility surveys, focusing on questions that are informative rather than repetitive. Sites will then be able to leverage an AI-driven workflow to accelerate survey completion with context-specific responses highlighting Site qualifications for the specific study.

• Study Start-Up: New AI-driven contract negotiations will accelerate time to startup, in compliance with Site and Sponsor guidelines for contracts. In addition, a fully automated document exchange with Site eISF will provide the flexibility to tailor documents to specific Site networks or regions. The enhanced AI workflows will also simplify document management across startup and trial conduct, reducing administrative work for sites and sponsors.

• Remote Monitoring: Remote Monitoring will also receive an AI upgrade. New reports providing deeper insights into Study progress across Sites or at specific sites will be available, allowing for quick intervention and remediation to keep trials on track, and obviating the need for physical site visits.

These AI-centric product workflows will enter limited availability in October 2025 for early adopters. These workflows are built on Florence's validated and GxP-compliant infrastructure-trusted by over 37,000 research sites globally. They include full audit traceability, 21 CFR Part 11 support, and interoperability APIs for CTMS, eTMF, and identity systems.

"We're not just automating the trial conduct for speed," said Shankar Jagannathan, COO at Florence. "We're creating a shared, AI-augmented experience between sponsors and sites to reduce manual work and increasing capacity, while minimizing risk -one that's more intelligent, scalable, and efficient."

About Florence Healthcare

Florence is a purpose-built platform that connects sponsors and sites to accelerate clinical trials, improve operational capacity, and reduce risk. Designed for scale, Florence streamlines workflows, enhances collaboration, and delivers real-time visibility across studies-empowering research teams to move faster, stay inspection-ready, and increase trial throughput with fewer resources.

For more information, visit www.florencehc.com

Press Contact:

Lautel Okhio
Communications, Florence
[email protected]

SOURCE: Florence Healthcare

View the original press release on ACCESS Newswire

D. O'Sullivan--BTZ