The modern Electronic Trial Master File (eTMF) is no longer merely a document repository, but an effective platform for accelerating your clinical trials, reducing compliance risks and ensuring real-time communication with research sites.
With clinical research complexity and workload on the rise, how is the eTMF changing and what should you be looking for in a new system?
In this post, we outline five capabilities every eTMF must include for optimal efficiency and integration at your organization.
These five capabilities will propel your eTMF system beyond document storage, security and access controls, version control, audit trails, and system validation, and drive compliance throughout your study.
Advanced Reporting and Tracking: Increase Operational Efficiency
Advanced reporting capabilities and project milestone tracking allow the sponsor/CRO to identify bottlenecks in clinical trial operational processes quickly. These bottlenecks in document cycle time assist in actively identifying potential delays in the clinical trial and uncovering compliance risks.
When coupled with real-time trial site eISF connectivity (below), this reporting and tracking feature is deployed across all research sites participating in the study to gain study-wide insights.
How Florence eTMF helps: Global Dashboards provide a birds-eye view of document status across all studies and research sites – identifying bottlenecks that are impacting performance.
Real-time Trial Site eISF Connectivity: Improve TMF Completeness
The eTMF should actively assist in ensuring TMF completeness by integrating directly with the research site Electronic Investigator Site File. This connectivity allows for real-time, quality controlled, document exchange with sites – significantly reducing document cycle time.
CRAs can proactively manage compliance risks by quickly identifying missing documents, expired documents, and incomplete documents across both the Sponsor/CRO eTMF and all participating research sites.
Remote monitoring capabilities of direct eTMF-eISF connectivity reduce the amount of time CRAs must spend on site, and free up time for larger projects.
How Florence eTMF helps: Florence eTMF is directly integrated with the largest eISF network in the world – with over 5,000 research sites digitally connected. This direct connectivity enables document and data exchange with research sites, remote monitoring, and quality control.
Standardized Flexibility: Reduce Compliance Risks
Balancing flexibility and standardization is essential for reducing compliance risks across the organization. The eTMF platform must be flexible enough to match existing sponsor/CRO workflows, with the ability to then standardize those processes across a geographically dispersed network.
Configurability is critical to maximizing flexibility. The sponsor/CRO should not have to adjust existing workflows to meet the “out-of-the-box” standard structure of the eTMF.
Once configured, the eTMF must be able to be “locked down,” so all teams, and research sites, if connected to the eISF, maintain a standard structure.
To assist, the eTMF vendor should supply a guiding reference model that supports you through SOP and workflow creation during your transition from a paper trial master file to eTMF.
Standardized flexibility also ensures the sponsor/CRO can integrate best in class platforms for all clinical trial operations through open APIs. An open API gives any platform the flexibility to seamlessly integrate with other systems in your technology ecosystem.
This level of standardization and flexibility must also apply to the types of roles that are permitted to access, view, edit, and change documents and data.
How Florence eTMF helps: We build our platforms to maximize Standardized Flexibility. Each installation can be configured to your existing workflows while maintaining the ability to standardize those processes across the entire organization.
Prebuilt Workflows: Eliminate Redundant Tasks
The eTMF platform should have expanded workflow capability with eSignatures that facilitate contract execution, training sign-offs, and internal SOP management within the platform.
eTMF workflows should be able to support the sponsor/CRO in external document exchange as well as internal document management.
Look for an eTMF system that has workflows integrated within the platform that allows your organization to complete both external and internal facing tasks quickly.
For small and medium sponsor/CRO organizations, the traditional eTMF requiring two or three IT FTE employees to manage is a non-starter. To effectively balance budget and capabilities, the eTMF platform must be easy to set-up and use – meaning it must be intuitive to the basic user.
Simple navigation, easy file finding, actionable alerts, and a dedicated support team are the basic requirements of a modern eTMF.
Another critical feature is intuitive step-by-step workflows for every document.
With multiple stakeholders in different locations, the eTMF vendor should offer remote and straightforward training. Thorough training ensures compliance and mitigates risks.
How Florence eTMF helps: Florence assists the small to medium-sized sponsor/CRO who needs an easy to set-up and use platform. Created with a “three-click” design, we work hard to ensure nothing is more than three clicks away at any time. Our robust training, implementation, and customer support teams work hard to not only provide great software but also lead change management at your organization.
Being stuck with the wrong eTMF for your organization can slow you down and disrupt your regulatory workflows. These are just 5 of the 80+ capabilities that you should be looking for in your new eTMF. To see all the capabilities you should watch for, download our Capability Checklist here.