Your co-pilot for clinical monitoring
Medable’s CRA Agent is an AI-driven solution that automates and optimizes clinical trial monitoring by proactively identifying and prioritizing site risks, generating comprehensive pre-visit summaries, and providing actionable recommendations to enhance trial oversight and compliance.
We estimate that CRA agents can take on up to 90% of the tactical and administrative work the CRA handles on a daily basis — from sending site-specific emails and reminders to tracking responses and updating systems. That means we can focus our time on the strategic decisions that move trials forward, while standardizing and streamlining the tasks that used to consume most of our day.
Connected monitoring across systems
Perceive signals across the entire clinical data ecosystem by unifying CTMS, RTSM, EDC, labs, consent, and safety into one view. Turn manual checks into automated insights, instantly highlighting which sites are on track and where intervention is needed, saving valuable time, system-hopping, and manual data compilation.
Human-in-the-loop oversight
Easily identify risks and recommendations for best-next actions tied to your protocol, consent, and regulatory requirements. Stay assured with a transparent reasoning trail thatshows why each step is advised, enabling CRAs to collaborate confidently with sites, improve decision-making, enhance their compliance, all while freeing CRAs to focus on engagement and site-specific challenges.
Automated administrative tasks
Take advantage of automated routine tasks like drafting queries, sending emails, and updating CTMS/eTMF — always with human CRA oversight. Close the loop between planning and execution with real-time tracking that reduces administrative burden, ensures data consistency, and accelerates trial progress.
The latest from Knowledge Centers
What happened at JPM 2026?
Each January, the J.P. Morgan Healthcare Conference sets the tone for the life sciences industry, serving as the year’s most influential gathering of biotech, pharma, investors, and dealmakers.
This year was no different.
Thus, we checked in with our conference attendees, booth visitors, and more to see what they thought were this year’s trend-setting takeaways.
How Agentic AI is transforming life sciences discovery and operations
The numbers are in, and they spell change for life sciences.
That’s because nearly three-quarters (73%) of global pharmaceutical organizations are actively planning, piloting, or deploying agentic AI initiatives.
This widespread means agentic AI is no longer a futuristic concept, but a present-day imperative for staying competitive and delivering life-changing medicines faster.
For those not yet in the know, agentic AI is a sophisticated form of AI designed not just to analyze data, but to act autonomously, plan, reason, and execute complex, multi-step tasks. This goes far beyond traditional automation. Instead, agentic AI is about creating intelligent systems that can drive innovation, accelerate drug development, and optimize operations like never before.
So, which companies are leading the charge, and how exactly are these intelligent agents reshaping the pharma landscape? Let's dive into the specifics.
Playing catch-up: FDA wants “patient’s voice” ePRO in your oncology trial
For years now, the FDA has been making one point crystal clear to sponsors and CROs across our industry; they want the patient voice incorporated whenever possible in oncology trials.
The FDA's initiative is driven by the recognition that a patient's personal experience with a disease and its treatment is a unique and essential measure of a medical product's benefit and risk.
- Rationale: The FDA explicitly states that "patients provide a unique perspective on treatment effectiveness" and "some treatment effects are known only to the patient." Outcomes that truly matter to patients, such as functioning, quality of life, and the burden of side effects, are often best measured directly by the patient.
- Mandate: The Patient-Focused Drug Development (PFDD) effort, codified in part by the 21st Century Cures Act, requires the inclusion of such patient experience data in clinical research.
- Guidance series: To formalize this approach, the FDA has released a series of methodological guidance documents (the PFDD Guidance Series) that outline how stakeholders should collect, submit, and use patient input to inform medical product development.
Eliminate clinical trial white space with the right AI strategy
It has become clear that our industry has reachedthe limits of human-only clinical development. As clinical trials have become increasingly complex, the endeavors that people alone can perform are no longer sufficient to generate the momentum needed to address the growing burden of human disease. This has led to longer drug development timelines and significant delays for patients. One large are of lost time is “white space,” definied simply as unproductive time caused by manual, sequential processes and fragmented data systems. Thankfully, a solution lies in agentic AI and its abilities to perform series of tasks.