Electronic Trial Master File or eTMF is not a new thing on the market, yet there are still companies working with paper solutions.
Of course, every single eTMF provider now has a “Now it’s time to change to eTMF because it’s online” kind of article, but we at Flex Databases believe, that eTMF is more than just cloud storage.
Here’s a comparison of a standard TMF with Flex Databases eTMF:
Paper TMF
eTMF
Limited physical access, no possibility for remote access
Safe instant access from anywhere in the world
Limited search abilities due to the huge amount of physical papers
Powerful search engine: find any document in one click
No progress tracking is available within the paper documents, additional efforts are required
Real-time progress tracking: everyone is on the same page with what is done and what needs to be done
Limited activity tracking options available, additional efforts and resources are required
Full Audit trail tracks all actions within the system: Who, What, When, Where, and Why
Countless working hours required to prepare paper files for an audit
Automated folders completeness statistics, missing documents reports, and various notifications ensure constant inspection readiness
Paper documents require a lot of expensive storage space and can be easily destroyed by any way of physical damage
Cloud-based applications reduce storage costs to a minimum. Data in a cloud is safe and also cannot be destroyed by a fire, flood or any other way of physical damage
Additional trackers are required to maintain the relevance of paper TMF, follow timelines for essential documents, and monitor expiry dates
eTMF provides customizable metadata for any document, an ability to set up notifications on any metadata related events (such as expiry dates) and use metadata for various reports building
Paper TMF simply does not provide any functionality on top of the “being a document storage” feature
Customizable widgets and reports assure trial transparency and provide information for data-driven decisions
Flex Databases offers migration from paper to digital in 5 weeks.
Regulatory Binder Checklist for Clinical Trial Documentation
A regulatory binder is crucial for managing clinical trial documents, it ensures compliance with regulations, and makes audits easier. It helps keep important documents organized and readily accessible for trial monitors, auditors, and regulatory authorities, and serves as a useful reference for the research team. While it’s not legally required, maintaining a regulatory binder is […]
Trial master files (TMFs) are essential for completing clinical studies, but managing TMF content can be very complex. Electronic trial master file (eTMF) systems represent the next step in clinical trial document management and are becoming an integral part of future clinical research. What is an eTMF? An electronic trial master file (eTMF) is a […]
Strategies for Effective Site Selection and Management in Clinical Trials
Effective site selection and management are critical components of successful clinical trials. Choosing the right locations and overseeing their operations can significantly impact the trial’s timeline, budget, and ultimately, its success in delivering reliable data. This article explores essential strategies for optimizing site selection and management, highlighting key considerations, practical tips, and the role of […]
Handling a Trial Master File (TMF) can be tough for clinical teams, but it doesn’t have to be. Old systems with outdated file sharing methods or homemade systems with spreadsheets or paper can make managing sensitive trial data risky. Over the past decade, electronic Trial Master File (eTMF) systems have helped many biopharma companies and […]
Get in touch to discuss compliance, implementation, demos, pricing
We are here for all of your questions! Tell us more about yourself and we will organize a tailored live demo to show how you can power up your clinical trials processes with Flex Databases.
Thank you for your interest.
Thank you for your interest. We are working on your request and will come back to you in the next 24 hours.