Did you miss our recent webinar on Quality Digitalization? The recording is now available! In this insightful session, Anna Petrovskaya, QA Director at Flex Databases, and Vera Valesova, PhD, Senior Manager at Deloitte, explore the critical aspects of transforming your QMS into a digital solution. Key topics covered: Watch the full webinar and gain valuable […]
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!