5 examples of data sets that are shared between Flex Databases CTMS & eTMF

May 19, 2023

5 examples of data sets that are shared between Flex Databases CTMS & eTMF

A study published in the Journal of Medical Systems found that integrating eTMF and CTMS systems resulted in a 50% reduction in the time required to identify missing documents and a 75% reduction in the time required to resolve missing document issues. Flex Databases CTMS & eTMF are interconnected to deliver you the highest possible level of data completion and avoid missing documents issue.

Let’s have a look at the types of data that are shared between our CTMS & eTMF.  

  • Study and site information: study protocol, study team details, site locations, and contact details for site personnel.

Investigators and Sites Management – a part of CTMS where all the medical institutions are added once and then can be assigned as sites for any project

  • Subject data: subject demographics, screening, enrollment, and randomization data.

Subject Tracking and Invoicing – a part of CTMS to track enrollment and distribute the information across the system

  • Visit and monitoring data: visit schedules, visit details, assessments, and procedures performed along with monitoring reports, follow-up visits, and any corrective and preventative actions taken.

CRA Activity Management – a part of CTMS to arrange all monitoring activities, create monitoring reports, and manage the project

  • Regulatory documents: Investigator Brochure (IB), protocol amendments, and Institutional Review Board (IRB) approvals.
  • Site communication: site initiation and closeout documents, training records, and any correspondence between the study team and site personnel.

At the end of the day – an e-system is not a place to put all the information in, it is a place to find the information and use it. So go ahead and use everything you have in it. For example, once you created a monitoring report in CTMS send it directly to your eTMF and use it when needed.

Schedule a demo of our CTMS and eTMF to see how it works in real life!

Blog

December 19, 2024
Product Updates: December, 2024

We are excited to announce several new features and improvements to Flex Databases’ modules. These updates aim to streamline workflows, enhance usability, and improve overall efficiency for our users. Here’s an overview of the latest developments and their benefits. Trial Master File (TMF) Duplicates Search: Files Content Comparison Path: Trial Master File → (open project) […]

December 18, 2024
How Clinical Trial Sites Can Meet Sponsor Expectations in 2025

Clinical trials are becoming more complex every year, and sponsors are raising the bar for what they expect from sites. They want faster processes, more accurate data, and better ways to keep patients engaged – all while staying compliant with ever-evolving regulations. As we look ahead to 2025, these demands will only grow. New technologies […]

December 2, 2024
Flex Databases Achieves ISO 27001 Certification

We’re pleased to announce that Flex Databases’ IT security measures are now formally certified under ISO 27001. This certification, earned after a thorough audit, demonstrates that our systems meet internationally recognized standards for information security. ISO 27001 sets requirements for managing sensitive company and customer data securely. By achieving this milestone, we assure our clients […]

November 28, 2024
The Future of AI in TMF

The Trial Master File (TMF) is the cornerstone of clinical trial documentation, serving as the definitive record of compliance with regulatory standards and ethical guidelines. Yet, the management of TMFs has grown increasingly complex with the rise in document volume, diversity, and stringent compliance requirements. Artificial intelligence (AI) is poised to address these challenges, introducing […]

Contact us

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.