With new UK clinical trial rules landing in 2026, the EU Biotech Act on the horizon and China and Australia gaining ground, CROs are zeroing in on study timelines, AI/ML and data privacy as the industry’s next pressure points.
Pending and proposed changes to UK and EU clinical trial regulations, especially concerning trial timelines, are among the key focus areas for CROs in 2026, said Kathy Noonan, senior vice president of global regulatory policy at the Association of Clinical Research Organizations (ACRO), in an interview with BioSpace.
Other topics that have engaged members include AI/ML and data protection and privacy.
The Washington, DC-based ACRO has 15 members, including global CROs such as ICON, IQVIA, Parexel and PPD, and technology and platform companies such as Medidata, Oracle and Zelta. In 2024, ACRO members employed more than 73,000 individuals across Europe.
Noonan said there has been increased recognition within life sciences of the need for Europe to bolster its clinical competitiveness versus the U.S., China and Australia. As BioSpace previously reported, in-China trial volume has risen rapidly compared to the U.S. and Europe, positioning the country as a major global player in clinical development. Australia has also become an attractive hub for clinical studies, especially early stage trials.
UK/EU Regulations at the Forefront
ACRO’s European regulatory committee analyzes regulatory policy and legislation impacting the clinical research industry at the pan-European and national levels in Europe. It has engaged in industry consultations to press for faster trial timelines in Europe, Noonan noted.
A key CRO industry interest is the revised UK clinical trial regulations which take effect on April 28, 2026, and aim to strengthen participant safety and accelerate research. Key changes include legally requiring trial registration on a public register and the publication of results within 12 months, streamlining the application and approval processes with a single application route and harmonizing with international standards.
Noonan said there is also much member attention on the EU Biotech Act, a proposed legislative package from the European Commission intended to boost the European biotechnology sector. Its primary goals are to simplify regulations, accelerate product approvals and streamline processes to help biotech innovations move from the lab to the market more quickly. The act also aims to improve access to funding for biotech companies and enhance the workforce’s skills.
In terms of regulatory guidelines, ACRO members are also revamping processes to implement the ICH Guideline for Good Clinical Practice E6 (R3), published in January 2025. In terms of key changes from previous guidance, they “reflect advancements in trial design, technology and the digital ecosystem for trials, with expanded content on data governance and computeri[z]ed systems.”
AI/ML Remain Priorities
In addition, to faster trial timelines, ACRO members are invested in AI/ML growth, Noonan said. The organization has a committee that convenes member company subject matter experts engaged in the development and use of AI/ML tools in the design, conduct, oversight and analysis of clinical trials.
In April, ACRO submitted comments to the FDA on its draft guidance “Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products.” Overall, the organization supported the guidance, as it found it “flexible, pragmatic and very risk-based” and provided industry with the confidence to develop these applications further, Noonan said. ACRO expects the European Medicines Agency to issue AI/ML- related guidance documents soon as well, with the hope the FDA document will be a good model.
ACRO plans to survey its members about how its members are using AI/ML internally, in terms of operational uses and how they are incorporating it into clinical trials.
U.S. lawmakers have a keen interest in incorporating AI into clinical research, with many conversations in the Senate, noted Fiona Lewis, ACRO’s advocacy associate. The aim is to drive U.S. leadership in the AI field, especially in terms of competition with China.
Another intersection with AI that ACRO members are increasingly interested in is sustainability, said Maddy Sever, the organization’s communications and member associate. “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,” she said. ACRO’s members are in turn seeing customers increasingly ask for sustainability metrics, she added. The organization created a sustainability committee this year to focused on advancing sustainable practices in clinical research.
Eye on Data Protection and Privacy
Data protection and privacy issues directly impact ACRO members, Noonan said. As CROs handle sensitive data across increasingly global trial sites, cross-border data security is a concern.
Pharmaceutical companies must share proprietary knowledge, patient information and intellectual property with their CRO partners when outsourcing highly sensitive research tasks. However, the methods used to transfer this information introduce security vulnerabilities that may result in data leaks, unauthorized access to protected assets or accidental exposure of private details, according to a Business Research Insights report. Another caveat is that data protection regulations vary widely among countries.
The topic is relevant as according to internal research, 50% of clinical trials have data capture issues, said Ali Pashazadeh, founder of TreeHill Partners.
An internal ACRO committee comprised of member company data protection and privacy professionals considers relevant legislation and regulation globally, including hot topics such as data localization and transfer, Noonan said. In addition, the committee engages with professional colleagues such as European Federation of Pharmaceutical Industries and Associations and the International Pharmaceutical and Medical Device Privacy Consortium, Noonan added.
