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Association of Clinical Research Organizations

ACRO

ACRO and its members advocate on a global basis for safe, ethical, high-quality medical research so patients can benefit from the development of new treatments and therapies.

Lobbying Activity

Response to Biotech Act

10 Jun 2025

Thank you very much for this opportunity to respond to this Call for Evidence on the European Biotech Act. I am submitting a response on behalf of ACRO (Association of Clinical Research Organizations). The response is attached here as a Word document. Please see attachment. Respectfully submitted, Karen Noonan Senior Vice President, Global Regulatory Policy ACRO
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Response to EU Life sciences strategy

16 Apr 2025

The Association of Clinical Research Organizations (ACRO) is pleased to provide the attached document. Please see attached PDF. Thank you. Respectfully submitted, Karen Noonan Senior Vice President of Global Regulatory Policy Association of Clinical Research Organizations (ACRO)
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Response to Report on the application of the General Data Protection Regulation

8 Feb 2024

I write on behalf of the Association of Clinical Research Organizations (ACRO) which represents the worlds leading clinical research and technology organizations. ACRO member companies provide a wide range of specialized services across the entire spectrum of development for new drugs, biologics and medical devices, from pre-clinical, proof of concept and first-in-human studies through post-approval, pharmacovigilance, and health data research. ACRO member companies manage or otherwise support a majority of all biopharmaceutical-sponsored clinical investigations worldwide. From ACRO's perspective, the lack of harmonisation across member state DPAs in the application of the GDPR to the use of health data obtained as part of a clinical trial has made trans-national research studies challenging, and the lack of guidance from, for example, the European Data Protection Board, has been problematic. Two illustrative examples follow: 1) The fundamental question of who is the controller and who is the processor of data in a clinical trial: the sponsor of the study who holds ultimate responsibility for the conduct of the study and the use of study data or investigator/study site who collects the data? Currently, we are in a situation where sponsors and sites/investigators are agreeing they are controllers and processors for essentially the same data categories in objectively the same circumstances in different EU countries. 2) One member state DPA has offered a prescriptive interpretation of the GDPRs application to technology-based outcome measures (TOMs) in clinical trials. In effect, a single DPA has determined what is appropriate in terms of TOMs and the management of patient identifiable data and study data and has implemented a process for approving deviations from these TOMs without disclosing guidance in terms of how it will assess whether deviations from these methodologies are acceptable or not. We are certainly aware that member states may offer varying interpretations of and guidance for the application of the GDPR to clinical trials research. However, such lack of harmonisation makes the conduct of clinical trials across the EU quite challenging and results in significantly differing controller/processor obligations and data subject rights and protections across the EU. ACRO suggests that the Report should note these and many similar examples of the impact of regulatory disharmony and consider ways to encourage more consistent application of the GDPR across the member states.
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Response to Labelling requirements for unauthorised medicinal products used in Clinical Trials

28 Jun 2022

The Association of Clinical Research Organizations (ACRO) has appended a very brief reply which succinctly lays our our recommendations. As it is just a few characters beyond the maximum 4,000 characters, we believe it is best submitted as an attachment. Please see PDF attached here. Thank you. Respectfully submitted, Karen Noonan, Senior Vice President, Global Regulatory Policy, ACRO
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Response to Evaluation and revision of the general pharmaceutical legislation

26 Apr 2021

The Association of Clinical Research Organizations (ACRO) is pleased to provide five comments. 1—SIMPLIFYING THE LEGISLATION: Harmonising the interplay with other regulatory frameworks will be particularly important, especially for combined products. Harmonisation will provide predictability, fostering innovation in Europe. Please consider the lessons from COVID-19. Reducing times between dossier submissions and opinions, rolling reviews of data, and novel clinical trial designs sped up the approval of crucial vaccines. The implementation of the rolling review by the EMA for COVID-19 vaccines marketing authorisation applications has demonstrated that this regulatory mechanism has dramatically accelerated availability of medicinal products in the EU, resulting in conditional marketing authorization. This spirit of faster approval, and therefore faster patient access, should be carried over to the revision of the general framework. In particular, we recommend the rolling review should become the standard process rather than an exception. 2—FLEXIBILITY: The legislation must be able to adapt to innovation. Scientific and technological developments such as advanced therapeutics are testing the current regulatory system, which needs to be modernised. A crucial element of this will be leveraging novel sources of data (e.g. RWD and RWE) and use of novel clinical trial design. The revision should be aligned with the proposal to create a European Health Data Space. Both should support access to, and use of, high-quality data sets for clinical research and development. 3—SUPPLY SECURITY: We urge the Commission take a holistic approach to ensuring security of supply chains. This should extend beyond just manufacturing to include access to resources for R&D (including access to animals for scientific research). For example, an ongoing export ban on non-human primates continues to pose a risk to the development of innovative medicines in Europe at the source. We urge the Commission to work with international partners to ensure non-justified export bans are ceased and prevented in the future. 4—EMA: We encourage the Commission to think ambitiously about how the role of the EMA may be reformed. This may include a further shift to expertise-driven decision making, and closer collaboration with key stakeholders – including developers, CROS, and technology companies, for example through continual dialogue in the scientific advice process. 5—SCOPE: We recognise that this initiative is targeted specifically at selected content in Directive 2001/83/EC and Regulation (EC) 726/2004, but are disappointed that legislation relating to clinical research (specifically Regulation (EU) 536/2014) is not also included, as there is an inseparable association between clinical research and the initial marketing authorisation application and subsequent variations of the authorisation based on clinical data. At a procedural level, too, there is an intimate association between marketing authorisation procedures and clinical research data. For instance, although the EMA does not authorise clinical trials, the new CTIS established by Regulation will mean that the EMA will host the reports and data supporting clinical trial applications in the EU. As these data are also used to support marketing authorisation applications, this provides an opportunity to improve efficiency and streamline overall regulatory processes on the basis of “file once, use often” and make the information available for marketing authorisation evaluation without the need for resubmission of reports/data by applicants. This would allow for early, rolling review of pre-clinical data, for instance, which is often finalised while clinical research is still in progress, and help to reduce the overall timeline for evaluation of the marketing authorisation application when the clinical data package is complete. Thank you. ACRO (Association of Clinical Research Organizations)
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Response to A European Health Data Space

2 Feb 2021

02 February 2021 The Association of Clinical Research Organizations (ACRO) represents the world’s leading clinical research and technology organizations. Our fourteen member companies provide a wide range of specialized services across the entire spectrum of development for new drugs, biologics and medical devices, from pre-clinical, proof of concept and first-in-human studies through post-approval, pharmacovigilance and health data research. ACRO member companies manage or otherwise support the majority of all biopharmaceutical sponsored clinical investigations worldwide. With more than 200,000 employees, including over 60,000 in Europe, engaged in research activities in 114 countries the member companies of ACRO advance clinical outsourcing to improve the quality, efficiency and safety of biomedical research. ACRO welcomes the opportunity to comment on the Combined Evaluation Roadmap/Inception Impact Assessment on the European Health Data Space (EHDS) and, reflecting the interests of our member companies, has focused on the aim of the EHDS to promote access to health data for research and innovation. ACRO fully supports the Commission’s objectives for the EHDS and, specifically, the goal of improving access to, and exchange of, health data for scientific research and innovation, policy-making and regulatory activities. To facilitate this, it will be important that mechanisms are put in place for all researchers, including marketing authorization holders/clinical trials sponsors and organisations (such as CROs) acting on their behalf, to be able to access and analyse relevant health data. ACRO recognizes and agrees with the Commission that this poses specific challenges that need to be addressed in order to protect citizens’ interests and rights, and agrees with the issues identified by the Commission as “Problems the initiative aims to tackle”. Particular and important challenges for ACRO member companies are: (1) the lack of harmonisation between Member State regulatory authorities on the use and validation (often, a paper-based philosophy applied to the digital world) of digital tools in clinical research, which leads to increased cost and complexity in the conduct of research in the EU, and (2) the lack of harmonisation in the implementation of the General Data Protection Regulation (GDPR) by the Member States, resulting in fragmented requirements for processing of personal health data in the Member States, leading to obstacles and to limited access of researchers and public institutions. Both of these issues, in turn, reduce EU competitiveness and innovation potential at a global level. The GDPR-related challenges for clinical research stem from the application of a cross-sector (“horizontal”) regulation without specific consideration of the implications for research in the health sector. ACRO supports the Commission’s activities in developing standards for the ethical use of artificial intelligence (AI) but is concerned about the potential for similar problems should cross-sector legislation result, therefore ACRO strongly recommends that a specific and harmonised (across the Member States) sectoral policy is developed for the use of AI in health and clinical research. ACRO supports the Commission’s proposal to conduct studies to collect data and evidence in order to help determine appropriate policy options for the EHDS, and to perform an evaluation of the existing framework for cross-border exchanges of health data in order to assess the extent to which new legislation may be necessary in order to ensure free movement of digital health data and products, and to remove barriers for the deployment of AI systems in healthcare. Respectfully submitted, Karen Noonan Senior Vice President, Global Regulatory Policy, ACRO email: knoonan@acrohealth.org
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