Association of Clinical Research Organizations

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…

As the voice of leading global CROs (clinical research organizations) and global technology companies, ACRO monitors and analyzes initiatives, policies, legislation, and regulation impacting clinical research and drug development. In addition to participating in numerous public consultations and numerous industry stakeholder workshops on multiple topics within the clinical research enterprise, ACRO and its members are deeply engaged in addressing the requirements of the EU Clinical Trial Regulation and the General Data Protection Regulation. ACRO also follows initiatives and policies on innovation in clinical research and trial design -- in addition to the increasing digitization of clinical trials (e.g., decentralized clinical trials; electronic consent; electronic signatures; and emerging topics such as the potential and promise of artificial intelligence and machine learning to assist in drug development). ACRO current interests include the EU Biotech Act, the EU Revised General Pharmaceutical Legislation, and public consultations on draft guidance from the EMA, the Commission, and data protection authorities.

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