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An eTMF or electronic master file is software that digitally captures, manages, stores and shares essential documents of a clinical trial. These essential documents are collectively called the Trial Master File. Thus, eTMF software is the digital version of the Trial Master File.
Pharmaceutical, Biotech, Medtech company, involved in a regulated clinical trial must comply with government regulatory requirements surrounding those clinical trials. One of the key compliance criteria is to maintain and store what is called a Trial Master File. This is a set of essential documents and content that shows how a clinical trial was conducted, managed and followed regulatory requirements. These essential documents allow for the evaluation of the conduct and quality of the clinical trial.
According to Wikipedia “a trial master file contains essential documents for a clinical trial that may be subject to regulatory agency oversight…An electronic trial master file (eTMF) is a trial master file in electronic (digital content) format. It is a type of content management system for the pharmaceutical industry, providing a formalized means of organizing and storing documents, images, and other digital content for pharmaceutical clinical trials that may be required for compliance with government regulatory agencies. In order to comply with government regulatory requirements pertinent to clinical trials, every organization involved in clinical trials must maintain and store certain documents, images and content related to the clinical trial. Depending on the regulatory jurisdiction, this information may be stored in the trial master file or TMF.”
Most industries and processes that have typically been paper-based have matured and benefited from some kind of digital transformation over the year. Document Management software, Customer Service software, Project management software, Health Care Records, and numerous other categories of software have all made workplace processes far more efficient. The same thing goes for the pharmaceutical and biotech industry. The managing of Clinical trial regulatory documents has historically been a paper-based process fraught with errors and inconsistencies. The process is tedious and costly. Digitizing the process through the use of software in the form of eTMF software provides a digital strategy around the capture, management and reporting of regulatory documents that will enable clinical trial stakeholders to be more productive, effective and ultimately reduce business risk.
Capturing and managing clinical trial information and documents through paper-based or network-folder Trial Master File systems is tedious to manage, time consuming and can produce costly errors that may put your clinical trials at risk. Implementing eTMF software allows for more efficient management of documents, real-time oversight, ensures compliance and audit readiness throughout the trial. Key benefits include:
Most eTMF software vendors approach the feature set and design of their eTMF solution differently. Every vendor puts their own spin on how they track, process and show information on their platform. However, regardless of individual concepts and feature, the following core requirements are almost always present in all eTMF software solutions.
According to regulatory agencies, software used to store electronic records or digital documents and content are typically subject to the following requirements:
We have identified dozens of eTMF software solutions for you to review and compare.
