Martín Mosteirin
Partner, Marval O'Farrell Mairal, Buenos Aries
MJMO@marval.com

Camila Leone
Senior Associate, Marval O'Farrell Mairal, Buenos Aries
cal@marval.com

Carolina A Ramírez
Senior Associate, Marval O'Farrell Mairal, Buenos Aries
candr@marval.com

Introduction

Clinical trials are a fundamental pillar of the life sciences industry, as they provide indispensable data to evaluate the safety, efficacy, and quality of medicinal products. In recent years, the globalisation of pharmaceutical research has become a clear trend, with an increasing number of studies conducted across multiple jurisdictions. This evolution has highlighted the importance of harmonised regulatory standards and international cooperation to protect study participants and ensure the reliability of clinical data. Organisations such as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) – of which the National Administration of Drugs, Foods and Medical Devices (ANMAT) has been a Regulatory Member since June 2024 – play a central role in advancing regulatory convergence.

Against this background, Argentina has recently updated its regulatory framework for clinical pharmacology studies through ANMAT Regulation 7516/25, which incorporates the ICH E6 (R3) Guideline^[2] and aligns domestic requirements with internationally recognised GCP standards and principles. This new framework replaces ANMAT Regulations 6677/10, 4008/17, 9929/19, and 2172/25, and reflects sustained progress in regulatory harmonisation and Argentina’s increasing engagement in international regulatory forums.

Contemporary clinical trials are shaped by several key trends reflected in ICH guidance: (1) the use of digital systems for data collection, management, and monitoring; (2) strengthened participant protection through rigorous ethics and informed-consent processes; and (3) a well-defined allocation of roles and responsibilities among sponsors and investigators.

International cooperation

International cooperation has become a defining feature of contemporary clinical research. The globalisation of clinical trials requires close collaboration among regulatory authorities to ensure that studies are conducted ethically and that the safety, efficacy, and quality of medicinal products are maintained. In this context, the ICH Guideline for GCP, now incorporated into Argentina’s regulatory framework, provides a single internationally recognised standard designed to foster regulatory convergence and harmonisation.

This convergence is reflected in the formal adoption of ICH-GCP standards across leading regulatory jurisdictions, such as the United States, the European Union, Japan, and other ICH members. In parallel, several Latin American countries – including Brazil and Mexico – have advanced regulatory harmonisation processes aligned with these standards, reinforcing a broader trend toward regional convergence.^[3]

In this respect, Argentina’s alignment with the ICH Guideline facilitates the mutual acceptance of clinical trial data among regulatory authorities across ICH member regions. This harmonisation allows data generated in one country to be considered reliable and acceptable in another, thereby minimising unnecessary duplication of studies and enhancing the efficiency of global drug development. Such alignment also promotes greater confidence among international sponsors and regulatory authorities, which may encourage them to conduct studies at Argentine sites.

Good clinical practices: current trends

Current trends reflected in the ICH Guideline include the expanded use of digital and computerised systems in clinical trial processes, strengthened participant protection, and a structured allocation of roles and responsibilities.

The increasing use of digital and computerised systems

Since the adoption of ICH E6(R2), clinical trials have continued to evolve through new designs and technological innovations, requiring regulatory frameworks to adapt accordingly. This evolution contributed to the development of ICH E6(R3), which introduces a more flexible, principles-based approach designed to accommodate increasingly complex and technology-driven clinical trial environments.^[4]

Tools such as electronic health records, electronic patient-reported outcomes (ePRO), and digital platforms for safety reporting improve traceability and enable timely access to data by sites. The emergence of ePRO – patient self-reporting via mobile apps or web portals – as well as the use of wearables and sensors, enables easier and broader data collection.

Moreover, electronic reporting of adverse events facilitates immediate communication among investigators, sponsors, and health authorities, strengthening pharmacovigilance and enabling early detection of risks. In parallel, decentralised trial elements such as electronic audits and remote monitoring have gained prominence, improving operational efficiency and accessibility. Consistent with these developments, the regulatory framework accommodates decentralised and hybrid trial designs, including remote visits, telemedicine tools, electronic informed consent, and electronic data capture systems, all of which reflect the evolving operational realities of clinical research.

The ICH E6 (R3) Guideline establishes principles intended to support these modern approaches to trial design, which also introduce new challenges. Accordingly, the regulatory framework emphasises that processes for managing computerised systems should be ‘fit for purpose’,^[5] with safeguards to ensure proper data integrity, traceability, and security, thereby enabling accurate reporting, verification, and interpretation of clinical trial-related information.

Strengthened participant protection

Participant safety and well-being remain fundamental in clinical research and are further addressed through the informed consent process. Investigators must obtain and document freely given, informed consent from each participant, in strict adherence to applicable regulatory standards, and ensure that participants are adequately informed and able to make voluntary decisions, enabling them to evaluate potential benefits, risks, and burdens. Information should be clear and concise and, where appropriate, remote consent may be obtained. Participants should also be informed in a timely manner of new information that may affect their willingness to continue participation. Informed consent materials and procedures must receive prior approval of the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) before enrollment.

Ethical safeguards also extend to data protection. Participant confidentiality must be preserved in compliance with applicable data protection requirements, ensuring restricted access and secure handling of data.

In parallel, the sponsor is responsible for establishing and implementing appropriate quality assurance and quality control processes. These include risk-based strategies to identify potential or actual causes of serious non-compliance with the protocol, GCP, and/or applicable regulatory requirements, enabling corrective and preventive actions and ensuring that data are reliable and processed correctly.

Allocation of roles and responsibilities in clinical trials

The ICH Guideline maintains a clear and structured allocation of roles and responsibilities among sponsors and investigators involved in clinical trials. While specific tasks may be transferred or delegated to third parties, including Contract Research Organisations (CROs), the distribution of roles remains firmly defined, with sponsors and investigators retaining ultimate responsibility for their respective activities.

Accordingly, the ICH Guideline sets out a series of responsibilities for sponsors and investigators to safeguard participants’ rights and safety. Sponsors should incorporate quality into clinical trial design and ensure that the processes undertaken, and the information generated, are of sufficient quality to support reliable trial results and compliance with the protocol and ethical standards. In addition, sponsors are responsible for implementing a proportionate, risk-based quality management system to ensure that risks that may impact participant protection and the reliability of trial outcomes are properly identified, evaluated, and mitigated. Sponsors are also responsible for establishing and implementing quality assurance and control processes to ensure that trials are conducted in compliance with the protocol, GCP, and applicable regulatory requirements, including independent audits and monitoring activities. Most importantly, sponsors should submit safety updates, periodic reports, and all suspected unexpected serious adverse reactions (SUSARs) to the regulatory authorities. Any urgent safety issues requiring immediate attention or action should be reported to the IRB/IEC and/or regulatory authorities and investigators without undue delay, in accordance with applicable regulatory requirements.

Investigators are responsible for protecting the safety, rights, and well-being of trial participants throughout the study. They must ensure that participants receive appropriate medical care, manage adverse events, and maintain oversight of investigational product handling, dispensing, administration, and record-keeping, even when certain tasks are delegated to qualified personnel or CROs. Investigators must also ensure that informed consent is properly obtained; monitor adherence to the protocol and randomisation procedures; safeguard the integrity and confidentiality of trial data; and maintain complete, accurate, and traceable records. They are accountable for reporting safety events, trial outcomes, and relevant data to sponsors, the IRB/IEC, and regulatory authorities.

Within this framework, third parties such as CROs may be appointed to provide outsourced services to the pharmaceutical industry, offering expertise in a wide range of areas, including trial design, patient recruitment, data collection, regulatory compliance, and pharmacovigilance. However, their involvement does not alter the fundamental allocation of responsibilities: sponsors and investigators must maintain strict oversight of delegated activities and ensure that trial activities are performed in compliance with GCP, regulatory requirements, and ethical standards.

Conclusion

The landscape of clinical trials is evolving rapidly, driven by globalisation, technological innovation, and the fundamental obligation to ensure participant safety.

Harmonised international standards, such as those established by the ICH Guideline, play a crucial role in ensuring the reliability of trial data, facilitating mutual acceptance across regulatory jurisdictions, and minimising unnecessary duplication of studies.

The integration of digital tools and decentralised trial methodologies has improved data collection, monitoring, and reporting. Meanwhile, strengthened ethical safeguards – particularly regarding informed consent and participant protection – reinforce the central principle that human safety must remain the top priority.

Ultimately, the ICH Guideline reinforces a clear division of roles and responsibilities, safeguarding accountability throughout all stages of the clinical trial.