Authored by Pradnesh Warke, Partner, Dentons Link Legal; Bhushan Sharma, Partner, Baker Tilly ASA India LLP; Ravi R. Shekhar, Associate, Dentons Link Legal; and Aakancha Dixit, ASA & Associates LLP.

Clinical Trails

Clinical Trials are research studies conducted with human participants to evaluate the safety, efficacy, and side effects of new medical interventions, such as drugs, vaccines, or medical devices. Clinical Trials of drugs are usually carried out under four phases, from testing safety, dosage and side-effects to evaluation and confirmation, to assessment of long-term effects and benefits of the drug/device. Similarly, clinical investigation of medical devices is conducted in three stages which includes pilot clinical investigation, pivotal clinical investigation and post marketing clinical investigation. 

From rudimentary experiments to highly sophisticated, data-driven studies, clinical trials have undergone significant transformations.

In India, clinical trails are strictly regulated by the Central Drugs Standard Control Organization (CDSCO) through central legislations, most important of which are Drugs and Cosmetics Act, 1940, New Drugs and Clinical Trial Rules, 2019 and Medical Device Rules, 2017. The CDSCO, headed by the Drugs Controller General of India, oversees all clinical trials and investigations in India. Registration with the Clinical Trials Registry of India and approval from Ethics Committees are prerequisites for conducting trials.

Contract Research Organization

Contract Research Organizations (CROs) are crucial for managing clinical trials in the pharmaceutical and biotechnology space, which have the responsibility of bringing new therapies to market. CROs have become indispensable to the biopharmaceutical and medical device industries by providing comprehensive services to support clinical trials, including study design, patient recruitment, data management, and regulatory submissions. In addition to these, CROs also handle compliance with local and international standards, and can conduct quality assurance audits and manage post-marketing surveillance.

There has been a significant evolution in the role of CRO's from providing specialized services to becoming integral strategic partners in the drug development process. With their expanded capabilities, global reach, technological integration, and regulatory expertise, CROs are critical in navigating the complexities of modern clinical trials. With their ability to adapt to industry trends, focus on patient-centric approaches, and providing cost-effective solutions, CRO's provide the fundamental structure on which the biopharmaceutical and medical device industries function.


Over the last few years, there has been a substantial growth in the demand for CRO's, as the companies seek to accelerate drug development timelines while managing the complexities of global regulations.

Integration of Clinical Trials with Forensics and Legal Compliance

Presently, the integration of clinical trials with forensics and legal compliance is an important emerging area, which ensures the integrity of research processes and adherence to legal compliances. This integration is particularly crucial given the regulatory landscape in India, where the pharmaceutical industry is primarily governed by the Drugs and Cosmetics Act, along with its subordinate legislations such as the Drugs Rules, 1940, the Cosmetics Rules, 2020, and the Medical Devices Rules, 2017.

Forensic audits aid in uncovering potential issues, ensuring that trial results are reliable and legally sound, while Legal compliance involves adhering to a complex web of regulations, including Good Clinical Practice (GCP) guidelines, the CDSCO and Food and Drug Administration (FDA) regulations, as well as Drugs and Clinical Trial Rules, 2019 and Medical Devices Rules, 2017, which specifically govern clinical trials, clinical investigations, and related studies. Additionally, the National Ethical Guidelines for Biomedical and Health Research involving Human Participants, 2017 (ICMR Guidelines) set ethical standards to protect research participants in India.

To effectively integrate forensics and legal compliance, CROs must establish robust internal systems for monitoring and reporting, and foster collaboration between their legal, clinical, and forensic teams. Given the growing market for clinical trials in India, expected to grow at a CAGR of 8.2% from 2022 to 2030, CROs must stay ahead by ensuring adherence to these regulatory frameworks and leveraging India's diverse genetic pool and technical resources. By aligning these elements, CROs can not only ensure the validity and reliability of their clinical trials but also safeguard themselves against legal risks, ultimately contributing to the development of safe and effective therapies.

Role of Forensics in Clinical Trails

Forensic analysis in clinical trials involves the meticulous examination of data and processes to detect any irregularities or misconduct, such as data fabrication or fraud. This aspect of clinical trials has gained prominence as the industry seeks to uphold the highest standards of data integrity and patient safety. Regular reviews aid in identification of inconsistencies, non-adherence to protocols for informed consent, patient safety, and the reporting of adverse events, potential conflicts of interest which can influence the research, fraud and misconduct activities and non-adherence to trial's protocols, etc. Audit of a clinical trial provides the research sponsor with an independent appraisal of the quality, integrity and completeness of the data generated by the trial.

Onboarding of CRO’s is crucial to ensure their compliance with regulatory standards and verify their quality and performance track record to mitigate potential risks.

Forensics ensures clinical trial data integrity by verifying the accuracy of data collection, storage and reporting and by examining electronic systems for security and data protection.

CROs face risks related to Anti-Bribery and Anti-Corruption Act (ABAC) including the potential for facilitation payments to government officials, improper financial incentives to HCPs to influence their decision-making. These risks also extend to false reporting and financial manipulation to conceal unethical practices and the potential for corrupt activities by third-party vendors or subcontractors. To mitigate these risks, CROs must rigorously comply with regulations such as Good Clinical Practice (GCP), CDSCO regulations, applicable data privacy laws and international guidelines such as, ensuring adherence through thorough compliance verification and forensic audits.

Conclusion

Clinical trials are fundamental to advancing medical science and ensuring the efficacy and safety of new treatments. In India, a rapidly growing hub for global clinical research, maintaining the integrity and credibility of these trials is crucial. Forensic audits play a pivotal role in this regard, addressing issues related to data accuracy, regulatory compliance, and fraud detection. Used effectively, therefore, audits can reduce costs, maintain project schedules, and ensure regulatory compliance.


Dentons Link Legal in collaboration with Baker Tilly ASA India LLP is hosting a webinar on Integrating Clinical Trials with Forensics and Legal Compliance”.

Join us on Thursday, 29 August 2024 from 6 pm - 7:15 pm IST for an insightful session.

To know more and register for the webinar, visit: Webinar Registration - Zoom