Presentation asked what clinical data management can safely delegate to AI — and what makes that delegation trustworthy
Trialt, a global clinical
research organization (CRO) specializing in biostatistics, statistical
programming, data management, and medical writing, announced that Chief R&D
Officer Yuri Kartashov, PhD, delivered a keynote presentation this week at COG
CRO Summit Europe at Novotel Amsterdam City in the Netherlands. The event brought
together senior leaders from across the European CRO sector to discuss technology,
partnerships, resource optimization, site relationships and other priorities
shaping clinical research.
Dr. Kartashov’s presentation, “Assisted to Automated to Autonomous: Evolution and Impact of AI in CDM,” distinguished three modes of working with AI: assisted, where AI drafts and people decide; automated, where a predefined workflow runs within agreed rules and checkpoints; and bounded autonomous, where an agent chooses its next steps within limits people set and oversee.
Using a familiar example — a data query that AI could draft, send to a site or close — he shows how each added permission changes the evidence a team must demand, checks recent AI claims against documented outcomes in medical coding, data review, report generation and trial screening, and sets them beside documented failures and near misses. Findings from a pre-conference survey of CRO and sponsor data-management leaders point the same way: drafting is widely trusted, sending and closing queries are not, and supervised use rather than autonomy is what most expect by the end of 2027.
“A query drafted in seconds can still take days to resolve,” said Dr. Kartashov. “The unit of value is an accepted outcome, including the time people spend checking, correcting and recovering. Permission should follow evidence: start with one repeated task, keep a person approving each action, measure the work left for people, and expand only when the evidence supports it.”
The presentation also offered practical guidance on setting up an agentic workflow for routine data management tasks, such as query drafting, data-transfer comparison and reconciliation: how to give an agent narrow, named tools with read-only access to study data, where to place human checkpoints, how to bind each approval to the current data version, and how to test difficult cases before any live use. Dr. Kartashov outlined a first AI-assisted script, a learning routine that stays with the work, and the habits, skills and cost decisions that come with adopting AI. Attendees are invited to leave with one recurring task to turn into a tested, reviewable workflow.
“Yuri has spent years turning technology into working solutions for clinical research, which is why his view of AI is grounded in evidence rather than hype,” said Yaroslav Sud, VP of Biometrics, Trialt. “This talk gave data management leaders a practical way to decide what to delegate now, what to hold back, and what evidence to ask for before widening AI’s responsibilities.”
COG CRO Summit Europe is the EU-focused event in the global COG CRO Summit Series and is designed specifically for senior management and clinical operations professionals within CROs. Artificial intelligence for CROs is among the featured topics for the 2026 program.
For program information, visit https://www.thepbcgroup.com/cog-cro-summit-europe. To learn more about Trialt’s clinical data management expertise or to request a copy of the presentation, visit https://trialt.com/clinical-data-management/.
About Trialt
Trialt is the trusted CRO partner for biostatistics, statistical programming, data management, and medical writing. With expert teams across eight countries and deep engineering roots, we deliver tailored solutions designed to move trials forward and produce measurable results. Named “Company of the Year – Pharmaceutical Industry” in the International Business Awards, sponsors turn to Trialt to scale complex programs, recover at-risk studies, and meet critical timelines with confidence. Learn more at www.trialt.com.
Media Contact Don F. McLean, McLean Media +1-734-716-4182 ###
