By June 2025, the U.S. Food and Drug Administration will fully integrate generative AI into its review processes across all centers. This milestone signals more than a technology upgrade - it reflects a broader shift in how life sciences organizations are expected to operate: faster, more data-driven, and more intelligent by design.
For clinical trial sponsors and CROs, this is not a moment to sit on the sidelines. It’s an opportunity to adapt alongside regulators - to modernize internal workflows, rethink legacy review practices, and harness the same kind of AI-native infrastructure that will soon power regulatory decisions.
As the FDA integrates genAI to accelerate review cycles, reduce manual burden, and enhance decision-making, clinical trial sponsors and CROs have a unique opportunity to align themselves with regulators and adopt intelligent systems that keep pace.
The FDA’s move to integrate genAI is a call to action. Sponsors and CROs that modernize now will not only align themselves with regulators, but also operate with greater speed, clarity, and confidence. Our product, Vivo - the first agentic AI platform capable of reasoning over clinical trial data like a human expert - is in lockstep with this transformation, bringing genAI insights and decision support to clinical trial teams. By unifying study data across systems, detecting risks early, monitoring and forecasting enrollment, and making plain language insights accessible through transparent and explainable AI, Vivo equips clinical teams with the same kind of capabilities the FDA is now embracing internally.
The result is faster, more confident decision-making, reduced trial delays, and greater regulatory alignment, ultimately accelerating the pace, reducing the cost, and increasing the probability of success in clinical development.
“This shift by the FDA reflects urgency, not just to adopt new tools, but to respond to mounting pressures across the clinical development landscape including rising trial complexity and expectations for transparency and speed. Vivo mirrors this evolution, helping sponsors move from static processes to dynamic, AI-driven approaches that are built for modern clinical trials.” - Michael Bell, VP of Product, OmniScience
Below we describe some of the interesting ways Vivo can help sponsors align themselves with the FDA’s adoption of genAI.
The FDA plans to use genAI to help reviewers summarize documents, reduce repetition, and focus on critical thinking rather than rote tasks.
Vivo mirrors this by surfacing critical insights from large volumes of structured and unstructured clinical data - whether from EDCs, CTMS, lab systems, or external documents. Just as the FDA will use genAI to focus human attention on higher-value analysis, Vivo empowers study teams to focus on outliers, anomalies, and actionable items across studies, rather than getting bogged down in data wrangling.
The FDA is redesigning its internal workflows and adopting genAI tools across its centers. As the FDA’s regulatory expectations and systems evolve with AI, sponsors and CROs need to modernize how they prepare for submissions and regulatory interactions.
Vivo helps clinical teams pre-emptively identify data quality issues, protocol deviations, or gaps that could trigger regulatory concern. It also assists in preparing narratives and responses by extracting justifications and summaries across multiple datasets - essentially pre-aligning with the FDA’s future AI-accelerated processes.
AI use within the FDA will require traceable, auditable outputs to ensure confidence in decision-making.
Vivo’s architecture is built to maintain a clear provenance trail - each insight is explainable and links back to source data. This level of transparency means that sponsors and CROs using Vivo can mirror the audit-readiness the FDA will expect from its own systems, creating a mutual trust environment.
The FDA is not automating humans out of the loop - it’s augmenting reviewers to be faster and smarter.
Vivo is designed around the same principle: augment human judgment rather than replace it. Its interfaces and notifications are meant to serve medical monitors, data managers, and trial managers, providing hypotheses, summarizations, or anomalies they can explore and validate, accelerating high-value work.
As the FDA gets faster with genAI, the regulatory feedback loop may tighten.
Vivo can help sites and sponsor teams respond faster and more accurately to regulatory requests by surfacing relevant data and documentation on demand. It becomes a live layer of intelligence that sponsors can use to stay nimble in this faster-moving regulatory ecosystem.
The FDA’s genAI initiative is more than a technology milestone. It’s a signal that clinical development must become more dynamic, integrated, and AI-augmented. For sponsors and CROs, this is about more than compliance - it’s an opportunity to accelerate success.
With Vivo, clinical trial teams gain access to the same kind of AI-driven synthesis, foresight, and traceability the FDA is now implementing. The result is a shared infrastructure and mindset that supports better oversight, faster trials, and ultimately, better outcomes for patients.
