Periodic TMF reviews automatically documented. Quality and completeness under control!
Let’s address an intriguing issue in the clinical trial landscape. It appears that while one third of sponsors are less than satisfied with the quality of clinical trials, an overwhelming 90% of CROs are confident in their high-quality delivery. The solution might lie in implementing transparent, easily trackable KPIs through systems like CTMS and eTMF.
Tracking and checking can be time-consuming, but this is where the automated quality review function within eTMF shines. It streamlines the process, allowing for:
While compliance is common among most companies, the real challenge lies in demonstrating this compliance. It’s crucial not just to adhere to the standards but also to effectively showcase it, whether it’s from CROs to sponsors, or from sponsors to inspectors.
We have a solution: automatically generated evidence of periodic TMF reviews. Set up the review schedule in the system, and it takes care of the rest – reminders, comprehensive document, and folder checks, recording all queries and resolutions, and then generating a detailed report. This makes sponsor oversight transparent and well-documented.
Enhanced Quality Review function allows for scheduled periodic reviews, selection of specific documents for review, assignment of reviewers, and progress tracking. Every step, from document checks to folder completeness, is recorded, and displayed in the system. Once the review is complete, a report on the periodic check is automatically generated, facilitating an easy demonstration of thorough oversight.
Get in touch for a demo on top of the page or just email us at bd@flexdatabases.com
We are excited to share that Flex Databases has been named a Top Clinical Management Provider for 2024 by Life Science Review. This prestigious recognition highlights our strong reputation and the trust placed in us by both customers and industry peers, reflected in numerous nominations from Life Science Review subscribers. This award comes at a […]
Clinical trials provide essential information on the safety and effectiveness of drugs. Sponsors ensure that investigators follow protocols and collect and report quality data. Quality in clinical trials means that the product or service meets applicable regulations and customer requirements. A Quality Management System (QMS) in clinical research ensures compliance with ethical, regulatory, and GxP […]
Metronomia, a leading Data Management and Biostatistics CRO in EU, has selected Flex Databases’ eTMF module to support one of its biotech clients. Simon Rückinger, Managing Director at Metronomia Clinical Research GmbH, explained their decision and what they expect from the partnership. “We needed a flexible and simple eTMF solution that could meet the specific […]
Clinical Data Management Systems (CDMS) and Clinical Trial Management Systems (CTMS) are two key tools that play crucial roles in this process. While they might sound similar, they serve distinct purposes and offer different functionalities. What is a Clinical Data Management System (CDMS)? A Clinical Data Management System (CDMS) is a specialised tool designed to […]
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.