AI Adoption in Clinical Trials Focuses on Operations, Drug Discovery, and Patient Engagement

Artificial intelligence was the hottest topic in clinical research during 2025, with the Food & Drug Administration, big pharma, and researchers exploring ways generative AI can help with drug discovery, the clinical trials process, and the regulatory landscape. However, clinical trials remain mired in operational inefficiencies that AI is now being deployed to address.

According to WCG's 2025 Site Challenges Report, nearly one-third of respondents ranked study startup issues around contracts, budgets, and system builds as the leading problem slowing clinical trials while nearly 20% cite trial financial management (payments) as a topmost burden. Further, 78% of sites classified as academic medical centers and site networks, and 69% as independent sites and physician practices all agree that "contract and budget issues" are the largest contributor to long study startup timelines. These same issues were highlighted with the same weight two years ago in WCG's 2023 report, signaling that no progress has been made.

Already 80% of pharmaceutical professionals use AI to find new drugs, as numerous AI-discovered or AI-enabled drug candidates are currently in clinical development. Insilico Medicine's drug for idiopathic pulmonary fibrosis (IPF), Rentosertib, is a fully AI-generated drug (both the target and the molecule were identified by AI) and has completed phase 2a trials with positive results. Molecules discovered using AI have also shown an impressive 80% to 90% success rate in phase 1 clinical trials, much higher than historic averages between 40% and 65%.

However, in the real-world yardstick for drug discovery success—full FDA marketing approval—no AI-discovered drug has yet struck gold despite the tremendous investment. Studies show that investments cost anywhere from $25,000 to $100,000 per use case for infrastructure, development, and operational costs. Plus, given the time it typically takes to bring a drug from discovery to market, it can take many years for an investment in AI drug discovery to yield any tangible return, if ever.

A recent analysis indicates that about 70% of ongoing site payment operations time is spent on paper-based invoice processing. In aggregate, this translates into thousands of hours per month where an invoice is manually entered into a system to process for payment. AI can eliminate this operational waste, and then proven returns on this AI investment can support a case for future investment in other areas.

AstraZeneca is using generative AI to expedite its five-year ambitions to be an $80 billion company, deliver 20 new medicines, and be carbon negative. The initial value-driving activities include the creation of AI assistants to help with 3D location detection on CT scans and facilitate knowledge extraction for clinical documents as well as an intelligent protocol tool built in partnership with medical writers.

An AI agent known as Grace has over the past year powered more than 50 phase 2 and 3 trials involving over 500,000 interactions with would-be and enrolled trial participants. The communications include phone calls, text messages, and emails to accomplish tasks such as screening participants and then making and reminding individuals about their on-site screening appointments. Grove's AI Participant Relationship Management works "behind the scenes" to surface critical trial insights in real-time, enabling research teams to make data-driven actions on screening and enrollment.

In the span of three years, Walgreens has positioned itself as a key player in the clinical trial ecosystem highlighted by more than 35 biopharma partnerships and the engagement of over 17 million customers participating in industry-sponsored studies. The company's clinical trials model is built around identifying and recruiting patients for trials, improving accessibility via 20 clinical trial sites housed within its community pharmacies, and understanding who and how to engage patients based on real-world evidence and analysis.

Winners were named in the 2025 SCOPE Best of Show Awards. This year four winners were chosen by the SCOPE community—two veterans to the space and two companies new to SCOPE: Anju Software, Medidata, Biorce, and Phastar.