Today’s clinical development teams are facing increased P&L pressure, requiring that they juggle many responsibilities while continuing to maintain oversight of patients and safety, mitigate risk, and deliver the highest quality data and results. With multiple stakeholders, tight timelines, and shifting priorities, delays caused by fragmented systems, manual data quality monitoring, and custom report generation can quickly derail progress.
Sponsors are increasingly mandating the use of AI solutions to overcome these challenges and streamline clinical development. While generative AI (genAI) has improved documentation processes—such as drafting protocols, consents, and regulatory submissions—its real potential lies in delivering on-demand insights that empower faster, more strategic decision-making.
Ask Vivo, part of the broader Vivo product, redefines how clinical teams access and interact with trial data. With genAI combined with unified data representing a single source of truth, stakeholders no longer need to sift through spreadsheets or navigate multiple portals.
Instead of waiting on reports or spending hours compiling information, genAI instantly delivers accurate answers and enables users to engage in iterative dialogs with an AI colleague. This allows clinical trial development professionals at all levels to make decisions in real-time, without waiting on custom reports and expending resources for the corresponding coordination effort.
Operations Teams: Operations leaders need quick access to metrics across all sites. With genAI, they can instantly query:
- Are there any sites with enrolled subjects that have not signed an informed consent?
- Which inclusion/exclusion criteria has resulted in the highest number of screen fails?
- What is the projected date by which site 203 will enroll 60 subjects?
This on-demand access helps teams resolve issues quickly, enabling smoother site management and keeping trials aligned with timelines and expectations.
Safety Teams: Safety teams often struggle with fragmented data and manual oversight. genAI eliminates these challenges by delivering insights on demand:
- How many early terminations are due to adverse events? What were the top 3 AEs?
- What are my most frequent special interest adverse events? At which sites are they most prevalent?
- What is the hazard ratio of adverse events for male vs. female subjects?
By streamlining safety monitoring, genAI reduces the chance of missing critical signals, enabling teams to act faster and more confidently to ensure patient safety
Clinical Teams: Researchers often spend days, even weeks, analyzing endpoint data for outliers and clinically meaningful patterns. With genAI, they simply ask:
- Are there any data discrepancies related to my primary and secondary endpoints?
- What are all endpoint scores for subject 205-012 at Visit 2?
- What concomitant medication was subject 201-021 taking prior to enrollment?
This instant access allows researchers to focus less on wrangling data and more on optimizing study designs, accelerating data-driven decisions and enhancing study outcomes.
Biopharma Leaders: Strategic planning and decision-making requires visibility into trial performance, safety risks, and operational milestones. Ask Vivo offers leaders immediate access to critical insights without relying on static dashboards or waiting on manual reports. Whether in meetings, investor discussions, or strategic planning sessions, leaders can access up-to-the-minute data to guide decision-making.
For example, with Ask Vivo, leaders can ask strategic questions and query specific key performance indicators on demand:
- How is portfolio-wide enrollment progressing across our active studies?
- What percentage of milestones are on track or at risk?
- Which trials have unresolved safety concerns?
By having real-time access to operational, safety, and clinical research data, leaders can plan proactively to address risks before they impact trial timelines and budgets. This capability enables better resource allocation, risk management, and portfolio strategy.
Biopharma teams leveraging genAI for enhanced oversight can unlock new efficiencies, improve data quality, and reduce trial timelines, ultimately accelerating the delivery of therapies to patients. Our product, Vivo, is a game changer for trial sponsors, providing access to the right knowledge at the right time. Request a demo or contact us to learn how Vivo can deliver on-demand insights for your clinical trials.
