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
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 […]
Clinical trials play a crucial role in medical progress, yet effective management is essential to maximize their impact. Administrators must craft a thorough strategy to enhance how trials are managed. Here are five strategies to transform clinical trial management, providing administrators with the tools and insights needed to navigate healthcare research challenges effectively. Simplify planning […]
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 […]
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.