On April 28, 2026, the FDA confirmed it intends to remove what it calls "dead time" from drug development. At Medable, we call it white space.
The agency’s pilot program for ‘real-time clinical trials’ points toward a model that replaces delayed, phase-based review cycles with more continuous regulatory engagement. Roughly 45% of the time between Phase 1 initiation and final submission is spent on administrative and non-clinical activities. By enabling regulators to monitor trial endpoints and safety signals in real time through cloud-based data sharing, the FDA aims to shorten the traditional 10–12 year development timeline.
At its May 15, 2026 Industry Day briefing, the agency confirmed that regulatory feedback back to the sponsor could occur with equal speed.
The pressure is coming from both directions. AI is compressing drug discovery timelines faster than clinical operations can absorb the output, filling pipelines with candidates the current infrastructure was never designed to handle at this volume or velocity. The sponsors that can absorb that volume by running multiple concurrent programs, rapidly adapting protocols, and maintaining continuous oversight at scale will be the ones whose molecules reach patients faster, while others stall in the pipeline.
"A regulatory model built for delayed static evidence cannot remain dominant in the world. And that world is continuous, it's rapid, it's continuous data, it's real-time analytics, and it's AI-enabled discovery. The current model is truly… not sustainable." — FDA, Industry Day, May 15, 2026
The agency's Head of AI framed the urgency in human terms: for patients, "time is life." The bottleneck is no longer science. It is the system surrounding it.
The Operational Foundation
Medable has spent years building the infrastructure, workflows, and capabilities required to support continuous evidence generation, continuous operational oversight, and flexible trial execution. What began as decentralized trial infrastructure has evolved into the operational foundation for Continuous Trial Management, now augmented by a clinical-native, AI-native platform designed to coordinate workflows, surface signals, and maintain oversight across the study lifecycle.
The FDA's model leaves the sponsor-side infrastructure open. Sponsors remain responsible for choosing the technology partners that can generate, monitor, and transmit the right signals from the right data sources.
The program's implications extend beyond Phase 1–2 submissions, as the agency's direction reflects a broader shift toward data-informed, signal-based regulatory engagement across clinical development, replacing disconnected phases and administrative handoffs with continuous evidence monitoring, oversight, and decision-making.
Prior Medable and Tufts CSDD research demonstrated that Decentralized Clinical Trials (DCT) deliver value beyond patient access and site flexibility by reducing operational friction, accelerating cycle times, and enabling more continuous evidence generation across the development lifecycle. That body of work is now the foundation for what the FDA is asking for.
Our 1:1:1 vision is the operational expression of that future.
1 Day
Study Start
1 Day
Enrollment
1 Year
Study Conduct
Adaptive, cohort-based oncology studies run at Medable for top pharma sponsors, and are a strong use case as they already rely on continuous progression, iterative learning, and cohort-level decision-making. Real-time data access means biomarker-defined subgroups can graduate earlier, as soon as sufficient safety and efficacy signals emerge, while other cohorts continue to accrue evidence, rather than waiting for all cohorts to complete.
What Continuous Trial Management Requires
Platforms can no longer function as isolated systems of record. In a continuous review model, they must generate, interpret, and coordinate signals across the clinical ecosystem, operating as a coordinated clinical operations layer that captures patient evidence, monitors study health, surfaces risk signals, and maintains inspection readiness throughout conduct.
Continuous Trial Management requires two capabilities working in concert.
Continuous evidence generation: Platforms capturing structured patient and care-team data in real time through eCOA/ePRO and eConsent workflows, with data remaining reviewable, exportable, and ready to support real-time review as it is collected.
Continuous operational oversight: Coordinated visibility across enrollment, protocol adherence, data quality, and clinical workflows, with governed AI that surfaces signals and supports decision-making while keeping humans in control.
Medable provides both. Medable does not handle regulatory submissions, but enables sponsors to generate, monitor, clean, and organize clinical evidence, so it is ready to support continuous review, signal reporting, and eventual submission.
The FDA’s announcement does not require Medable to build new capabilities. It encourages sponsors to deploy the ones already in production.
Evidence Generation & DCT
eCOA/ePRO + eConsent
eCOA/ePRO captures what happens with the patient in between visits, at a frequency and granularity that visit-based records alone cannot provide. eCOA/ePRO layers provide valuable insights, and complement one another. Medable's DCT/eCOA platform is that patient-side signal layer: structured, timestamped patient-reported outcome data and consent records that are review-ready from the moment of collection, continuously generating the clinical and operational signals that support ongoing review, monitoring, and decision-making throughout study conduct.
The no-code configuration of our platform supports how adaptive and umbrella trials actually run: cohort-based schedules, protocol agility, event-based capture, conditional workflows, and real-time visibility into enrollment, compliance, and data completeness. Sponsors can deploy amendments, expand cohorts, and monitor progress as evidence is generated without the historic challenges of reconstructing builds and extensive testing.
"With Studio you can now build dynamically, view it, test it, and keep moving. Whereas before we would build an entire study and wait two and a half weeks to test before we found out it wasn't working as intended. Now, we're being agile." — Director, Digital Health Delivery, GSK
eConsent extends that agility through remote patient options, improved presentation of complex information to enhance comprehension, dynamic updates, cohort-level versioning, and reduced IRB/EC burden via a unified application.
Data-on-demand and self-service exports, combined with ongoing cleaning workflows, let teams resolve issues in the moment, accelerating database lock and enabling staged data delivery and cohort review without freezing the entire study.
"With over 2,100 DCRs, Medable's adaptability in developing the app for data changes and managing the bulk DCRs was absolutely critical... been instrumental in reaching this important company milestone." — Therapeutic Area Leader, Top 5 Pharma
Outcomes:
- 5-day cohort enrollment
- 90% eCOA adherence
- Standardised data collection across cohorts for combinable outcomes
- Database lock through to press release in 2 weeks
- On-time IRB delivery across 3 Phase III studies built in parallel
See more sponsor outcomes here, with our case studies.
Agentic Clinical Development Making Real-Time Trials a Reality
In a real-time model, every signal must be traceable back to the source data, workflow, and human decision path that produced it.
Medable Agent Studio is the orchestration and governance layer for Continuous Trial Management. It enables sponsors to deploy validated AI agents across the development lifecycle connecting protocols, SOPs, regulatory guidance, study data, and operational workflows into a coordinated environment. Agents surface signals, identify risks, support review, and assist study teams, while sponsors and study teams retain control over the thresholds, parameters, and escalation criteria governing oversight and monitoring activities. Finally being able to remove some of the traditional human bottlenecks to make real-time trials possible, the agents are able to monitor, act and execute data cleaning activities in partnership with the clinical team members to radically reduce manual burden and effort.
Built for regulated clinical environments, Agent Studio includes human-readable audit trails, validation workflows, governance controls, and operational traceability supporting GxP compliance and inspection readiness in accordance with 21 CFR Part 11, GDPR, HIPAA, ALCOA++, and ICH E6(R3) GCP guidelines. As the FDA noted at its May 15 briefing: "AI does not make decisions at the FDA. Human beings make decisions at the FDA." Medable's agents were built with that same operating model.
Medable's Agent Studio is built on Model Context Protocol (MCP), an open standard for connecting AI agents to external data sources and systems in real time. That means integrating new data streams, including regulatory APIs as they become available, is a manageable configuration update, not a lengthy development or integration project. When the FDA makes its infrastructure and API specifications available, Medable is positioned to turn it into a live signal feed.
A closer look at Clinical Development Agents
The Clinical Monitoring Agent surfaces signals with visible reasoning, supporting data cleaning, operational review, and monitoring while presenting teams with a decision recommendations, not a workload. CRAs decide priority items; the agent finds and assesses trends and actions. With the Agent, timelines are shorter,, sites are better supported to optimise their success, and trials remain protocol and regulatoryadherent.
62% reduction in CRA task time (Phase II Inflammatory Disease and Phase III Oncology; based on data review and back-office monitoring tasks comprising ~40–70% of CRA workload) 1 hour of task effort → ~23 minutes with the CRA agent
The TMF Agent ensures you are always audit-ready by classifying and filing documents automatically, tracking TMF health, and flagging ALCOA++ issues at ingestion.
>60% fewer quality findings vs. human processing | 99% of TMF documents correctly classified Leveraged by Top 5 Pharma on live clinical studies
Agentic anomaly detection supports alerting of clinical trial teams regarding irregularities of data and project progress across eClincial systems like CTMS. As an example it supports site timelines, milestones, enrollment tracking, and operational continuity ensuring consistency of data across systems, maintaining CTMS as the primary source of accuracy.
Together, the platform enables continuous evidence generation while the agentic layer makes continuous review operationally sustainable.
"This gives us a holistic view, but what really matters is the site. Normally, we find out about enrollments or screen failures through hundreds of emails, easy to miss. Having that site-specific data right when we log in is a real game changer." — CRA, Top 10 Pharma Company
These are agents most sponsors and CROs choose to start with. From there, they expand. Agent Studio extends across the full study lifecycle. Beyond monitoring, TMF, and CTMS health, agents support Digital Data Flow, protocol activation, study startup, site management, enrollment, data review, and operational closeout, connecting the evidence generation layer with the operational infrastructure required to run studies continuously and keep them submission-ready throughout.
The Window Is Open Now
The FDA's program rewards sponsors who can generate clean, structured, continuously flowing evidence. Medable is built for this model, not adapted to it. Continuous data collection and real-time signal reporting enable the critical decisions (when to stop, pivot, or accelerate) to happen alongside evidence generation, rather than being deferred to an end-of-study review. Failing faster is the most efficient path to protecting patients and concentrating resources on programs with the strongest evidence base.
The longer arc points toward what the FDA calls "continuous trials," where conventional boundaries between Phase I, II, and III are progressively compressed and regulatory engagement is embedded throughout development. Sponsors on Medable are not building toward that readiness; they have it today.
The infrastructure gap between those who move now and those who wait will not be measured in months; it will be measured in programs.
Contact your Medable account team or visit medable.com.
Sources
U.S. Food & Drug Administration. "FDA Announces Major Steps to Implement Real-Time Clinical Trials." April 28, 2026. fda.gov
U.S. Food & Drug Administration. "FDA Industry Information Session: Real-Time Clinical Trials." May 15, 2026. fda.gov
