Pending changes to UK and EU clinical trial regulations are expected to be a major focus for contract research organizations (CROs) in 2026, according to Kathy Noonan, senior vice president of global regulatory policy at the Association of Clinical Research Organizations (ACRO). In an interview with BioSpace, Noonan highlighted that these changes, especially those affecting trial timelines, have drawn significant attention from ACRO members.
Other issues engaging CROs include artificial intelligence and machine learning (AI/ML), as well as data protection and privacy concerns. ACRO represents 15 member companies, including large CROs such as ICON, IQVIA, Parexel and PPD, along with technology firms like Medidata, Oracle and Zelta. As of 2024, its members employed more than 73,000 people across Europe.
Noonan noted a growing recognition within the life sciences sector of the need for Europe to improve its clinical competitiveness compared to regions like the U.S., China and Australia. Recent trends show that China’s volume of clinical trials has increased rapidly relative to the U.S. and Europe, positioning it as a key player in global clinical development. Australia is also attracting more early-stage clinical studies.
ACRO’s European regulatory committee reviews policies and legislation impacting the industry both at pan-European and national levels. The committee has participated in consultations aiming to shorten trial timelines in Europe.
A central area of interest is the revised UK clinical trial regulations taking effect on April 28, 2026. These rules aim to strengthen participant safety while speeding up research processes. Key provisions include mandatory public registration of trials and publication of results within 12 months. The new framework will streamline applications through a single route and align with international standards.
Attention is also focused on the proposed EU Biotech Act from the European Commission. This legislative package seeks to simplify regulations for biotechnology companies, accelerate product approvals, and help innovations move from lab to market more efficiently. It also aims to improve funding access for biotech firms and enhance workforce skills.
Regarding guidelines for good clinical practice, ACRO members are adapting their procedures following publication of the ICH Guideline for Good Clinical Practice E6 (R3) in January 2025. According to Noonan: “They reflect advancements in trial design, technology and the digital ecosystem for trials, with expanded content on data governance and computerized systems.”
In addition to regulatory developments, AI/ML continues to be a priority area for CROs. Noonan said ACRO convenes experts from member companies working on AI/ML tools used throughout clinical trials—from design through analysis.
Earlier this year, ACRO submitted comments supporting draft guidance from the FDA titled “Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products.” Noonan stated: “Overall, [ACRO] supported the guidance as it found it ‘flexible, pragmatic and very risk-based’ and provided industry with the confidence to develop these applications further.” She added that similar guidance documents are expected soon from the European Medicines Agency.
ACRO plans to survey its members about their internal use of AI/ML—both operationally and within clinical trials themselves.
Interest in AI is not limited to regulators; U.S. lawmakers are discussing how best to integrate AI into clinical research in order to maintain leadership over competitors like China. Fiona Lewis, ACRO’s advocacy associate said many such conversations are happening in the Senate.
Sustainability is another area where AI intersects with CRO operations. Maddy Sever, communications and member associate at ACRO said: “We’ve heard a lot about using AI and digital tools to create more sustainable trials… whether that’s decentralized trials or for internal operations.” Sever added that customers increasingly request sustainability metrics from CROs; this year ACRO formed a committee dedicated specifically to sustainable practices in clinical research.
Data protection remains a pressing concern as CROs handle sensitive information across global sites. Pharmaceutical companies must share proprietary knowledge—including patient information—with CRO partners when outsourcing sensitive tasks. According to Business Research Insights reports cited by BioSpace , methods used during this transfer can introduce vulnerabilities such as data leaks or unauthorized access; moreover data protection laws differ widely among countries.
Ali Pashazadeh of TreeHill Partners noted that internal research shows half of all clinical trials encounter data capture issues.
Noonan explained that an internal ACRO committee made up of data protection professionals tracks relevant global legislation on topics like data localization or cross-border transfers. The committee also collaborates with groups such as the European Federation of Pharmaceutical Industries and Associations (EFPIA) and International Pharmaceutical and Medical Device Privacy Consortium .
