Indian contract research organizations (CROs) have become increasingly well-integrated with electronic systems as the US FDA issues new guidelines regarding electronic records and signatures in clinical investigations.
These developments are crucial for ensuring compliance and maintaining data integrity in clinical trials. The global regulator’s focus on electronic systems suggests the growing importance of digital solutions in streamlining clinical processes, enhancing data accuracy, and improving overall efficiency. Indian CROs, with their advanced technological capabilities and familiarity with global regulations, are well-positioned to adapt to these changes, said industry experts.
CROs maximize sophisticated electronic data capture (EDC) systems, clinical trial management systems (CTMS), and electronic lab notebooks (ELNs) to facilitate the management and reporting of clinical data. By aligning with FDA norms, Indian CROs can enhance their credibility and competitiveness in the global market, making them attractive partners for pharmaceutical and biotech companies looking to conduct clinical trials, they added.
The emphasis on electronic systems not only helps ensure compliance with regulatory standards but also supports innovation in clinical research methodologies, ultimately benefiting the entire pharmaceutical development process, they said.
In March 1997, FDA published a final rule to establish criteria that generally must be met when a record required by a predicate rule is created, modified, maintained, archived, retrieved, or transmitted in electronic form in place of a paper record and when electronic signatures are used in place of handwritten signatures. In August 2003, it issued the 2003 part 11 guidance. This guidance provided recommendations that were narrowly tailored to reflect the technological environment that prevailed at that time.
FDA recognizes that since 2003, advances in technology have expanded the uses and capabilities of electronic systems in clinical investigations. In addition, electronic systems and technologies are used and managed in novel ways. It has noted that, services may be shared between organizations, and the electronic data flow between systems is more efficient and more prevalent. The capabilities of electronic systems have improved, and features such as automated date and time stamps, audit trails, and the ability to generate complete and accurate copies and to retain records are standard components of many electronic systems.
Accordingly, this guidance provides additional recommendations regarding the risk-based approach to validation to ensure the authenticity, integrity, and confidentiality of electronic data and records for clinical investigations when they are created, modified, maintained, archived, retrieved, or transmitted.
This guidance also addresses the applicability for electronic systems and information technology (IT) services used to create, modify, maintain, archive, retrieve, or transmit an electronic record as well as for the use of digital health technology (DHT) to remotely acquire data in a clinical investigation.
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