Please enable JS




The eISF, or electronic Investigator Site File, is the digital version of the paper-based investigator site file (ISF). It enables the collection in digital form of essential documents that demonstrate a clinical trial was conducted in accordance with Good Clinical Practice (GCP) guidelines, as well as regulatory and sponsor requirements. These documents include the protocol, informed consent forms, study reports, lab results, and other documentation related to the trial.

Leads to this page

The eISF is stored in a secure, web-based system that is accessible to authorized personnel only

The use of eISFs has several advantages over paper-based ISFs :
• efficiency in document management
• increases accuracy and completeness of data
• enhances security of sensitive information
• facilitates remote monitoring of study sites
• real-time data access and sharing between sites, sponsors, and regulatory agencies

Theuse of eISFs represents a significant step forward in the conduct of clinical research, enabling faster and more efficient trial management while ensuring compliance with regulatory and ethical standards.


telemedecine technologies news

How Are Healthcare AI Developers Responding to WHO’s New Guidance on LLMs?

January 31, 2024

Med City News This month, the World Health Organization released new guidelines on the ethics and governance of large language models (LLMs) in healthcare. Reactions from the leaders of healthcare AI companies have been mainly positive. In its guidance, WHO outlined five broad applications for LLMS in healthcare: diagnosis and clinical care, administrative tasks, education, […]

telemedecine technologies news

Can Machine Learning be Efficient in Organizing Patient Safety Event Reports?

January 31, 2024

Applied Clinical Trials Online Patient safety event reports (PSEs) play an integral role in hospitals for keeping accurate records of adverse events (AEs). A challenge faced by hospitals is efficiently and accurately classifying these AEs due to the sheer number of reports that are created. A recent study published in JMIR turned to machine learning […]

telemedecine technologies news

Supporting investigators and sites in the evolution to decentralised clinical trials

January 31, 2024

International Biopharma The growing uptake of decentralised clinical trials in recent years reflects several key drivers such as advances in remote monitoring technology and data analytics, the need to access broader, more diverse trial populations, and demand in clinical development for cost efficiencies and meaningful, real world study outcomes. However, we are at a point […]