The coordinator stared at a 400-page EHR export, convinced the week was lost—until an AI pre-screen flagged 23 likely-eligible patients before lunch. The room at SCOPE Europe 2025 didn’t cheer; it exhaled. This is the promise everyone here was chasing: minutes, not days.
During a fascinating session at SCOPE, two forces converged: AI-enabled data extraction to accelerate feasibility and screening, and a systematic, stakeholder-driven trial-experience program to reduce burden and lift retention. The throughline was clear: sustainable progress depends on governance, consent, and co-creation with the people who actually run trials—medical IT, investigators, site staff, and patients.
The Problem, Framed With Human Stakes
Manual pre-screening still consumes days when teams must open, read, and reconcile PDFs, notes, and labs across fragmented systems. In multi-country studies, variability in documentation and workflows compounds the drag. Attendees described eight-country randomized trials where sites started with very different levels of familiarity yet ramped faster once AI compressed review cycles: hours to process large document sets, and minutes—rather than nearly an hour—per candidate to determine eligibility. Those saved hours translate directly into earlier first visits, less caregiver burden, and investigators who can focus on clinical judgment instead of clerical search.
Speed alone, however, doesn’t scale. GDPR surfaced repeatedly in “can we contact?” and “who authenticates?” discussions. Consent provenance, data-use transparency, and auditability aren’t checkboxes; they’re the license to operate across borders. Skepticism at the site level is rational. If the goal is pace, permission must be earned.
Strategic Context: Governance Before Growth
Regulatory posture shaped hallway conversations as much as product demos. Data minimization and purpose limitation color every “find-and-contact” scenario. European network models show cross-border collaboration is possible, but only when governance is explicit and repeatable. The industry is moving from pilot sparkle to programmatic, policy-bound rollouts that withstand legal review and IRB/EC scrutiny. In short: what scales is what’s documented.
Solution, Not Sizzle: AI-Driven Data Extraction Where It Belongs—Inside Site Workflows
The best demonstrations were deliberately ordinary: eligibility terms parsed from both structured and unstructured records; automatic surfacing of missing labs; evidence traces that let reviewers see exactly why a patient was flagged. For multi-country feasibility, the same pipelines sized addressable populations quickly, calibrating protocol expectations to real-world realities rather than optimism.
A repeatable adoption pattern is taking shape. Start with governance that makes consent lineage, contact rules, and authentication unambiguous. Involve medical IT at the outset so endpoint security, SSO, and data-flow diagrams are solved before the pilot. Co-design the reviewer’s desk so coordinators work from a single, provenance-rich console instead of juggling systems. Measure the wins in plain terms: hours saved per 100 records, time to first contact, and conversion to consent. Publish outcomes so trust compounds.
Turning Voices Into Change: Trial-Experience Programs That Actually Move Needles
Running alongside the screening work, a portfolio-wide trial-experience program spanned most active studies. The design was deliberate: co-create the model with patients and caregivers; keep the core set small and open targeted follow-ups only when needed; deliver near-real-time dashboards to study teams; and distribute through existing digital rails to keep friction low.
Thousands of responses across countries and indications produced a denominator we rarely see. Three patterns were consistent. First, patients consistently valued site-staff interactions and support, underscoring that human connection remains the anchor even as digital scales. Second, trial burden drove dropout—time commitments and procedural invasiveness were the most common triggers, with technology friction close behind. Third, site-staff experiences improved as studies progressed, signaling the power of targeted onboarding and ongoing operational support.
Regional and indication-level differences demanded nuance. Lower scores in some East Asian cohorts appeared tied to cultural response tendencies as much as trial design, reinforcing the need for localization in both instruments and interpretation. The program responded by establishing a complexity-reduction workstream, prioritizing high-burden indications (for example, obesity protocols dense with eligibility and procedural requirements), and pushing for cross-sponsor benchmarking so insights compound beyond a single portfolio.
Limitations were acknowledged: uneven tracking of survey deployment, response bias, and questions about generalizability. Even so, the business case was clear. When dashboards repeatedly show that trimming 15 minutes from a visit correlates with better adherence and fewer early withdrawals, simplification becomes a mandate rather than a nice-to-have.
What Sponsors and Vendors Should Do Next
Institutionalize AI-enabled pre-screening and experience measurement as operating disciplines, not side projects. Codify data-use disclosures, consent lineage, and contact policies so sites don’t relearn them study by study. Budget for the unglamorous work—integration, SSO, DPIAs, and training. Put provenance-rich review consoles in coordinators’ hands, not just sponsor dashboards. Measure what matters: hours saved per 100 records, time to first visit, contact-to-consent conversion, early retention, and satisfaction by role. Share anonymized benchmarks across sponsors to accelerate learning and credibility. And keep telling real stories with methods and metrics—what changed in Tuesday’s workflow, what risks were managed, and what the numbers show now.
The Takeaway
AI, done right, augments human judgment at the site. The win isn’t “AI”; it’s trustworthy acceleration—faster, higher-quality screening and a trial experience that respects people’s time and privacy. That outcome becomes durable when medical IT, investigators, sites, patients, and sponsors co-create measurable improvements and then enshrine them in governance, workflows, and benchmarks.
If this conference had a single message, it was this: stop piloting; start institutionalizing. The shift from sparkle to system is how minutes replace days—again and again.
Moe Alsumidaie is Chief Editor of The Clinical Trial Vanguard. Moe holds decades of experience in the clinical trials industry. Moe also serves as Head of Research at CliniBiz and Chief Data Scientist at Annex Clinical Corporation.
Diana is the Founder & Managing Director at RD Privacy and a contributing columnist, specializing in privacy for the pharmaceuticals and life science sectors, particularly small biopharma companies, with extensive experience as a European qualified privacy attorney and Data Protection Officer (DPO).
