Blogs Case Studies White Papers

3 Ways Your eTMF Can Be the Champion of Your Clinical Trial

Visit LMK at the 9th Annual TMF Summit

Now that the holiday season is over, the TMF experts at LMK are refreshed, reenergized, and ready to help you tackle your most pressing TMF challenges in 2020. As part of our mission to ensure TMF success for all, we’ll be attending the 9th annual Trial Master File Summit on January 22nd and 23rd in Orlando, Florida.

 

At the conference, LMK will offer one-on-one consultation appointments with our TMF experts, where we hope to empower you to be the champion of your TMF. We want you to achieve a healthy TMF in 2020 because of the countless ways TMF health contributes to the success of your trial. But, in order to inspire you to be a TMF champion, the TMF experts at LMK have narrowed down their list and identified the top 3 ways your eTMF can be the champion of your clinical trial:

 

Enabling Real-Time Decision Making

Real-time access to TMF documents is a capability central to the digital transformation promises of eTMF technology. In the past, actionable data hidden within clinical trial documents might not ever be discovered, and certainly would not be available to clinical trial decision-makers until after a monitoring visit, data cut, or even trial close out. This valuable data, hidden within patient diaries, case report forms, or monitoring reports could give early warning of an uncontrolled variable, systematic protocol deviations, or a safety issue. With the aid of instantly available documentation, however, study decision-makers can detect a positive signal or make a critical protocol amendment before an unforeseen challenge threatens the entire trial.

 

Improving Collaboration

A modern multinational clinical trial could have hundreds of sites and thousands of patients. To support these sites and patients an even greater number of sponsor, CRO, and service provider contributors must work together toward a common goal. The TMF, when healthy, contains the narrative of a clinical trial and represents a single source of truth. From this single source of truth teams can work asynchronously but remain in harmony, all united by a shared understanding of the trial’s narrative arc. Take for example, the crucial relationship between a CRO’s monitors and study management. When an eTMF reduces the time to create and publish monitoring reports, monitors are able to act as the eyes and ears of the sponsor instead of merely collecting documents. More effective monitoring allows for compliance issues to be addressed before they escalate and improves sponsor-site relations—both of which contribute to successfully met enrollment timelines.

 

Facilitating Measurable Goals

Measuring the performance of a large clinical trial, especially one in progress, is a daunting task. Even when all a trial’s eTMF documents are available instantly, gaining actionable insight remains a challenge. For a study manager it is simply impossible to view enough documents to keep up-to-date on every unfolding aspect of the trial.

 

The real-time report generation capabilities of the eTMF, however, provide an ever-ready understandable assessment of TMF health and overall trial performance.  For example, TMF inspection readiness metrics based on document metadata, such as percent completeness and document cycle time, allow trial decision makers to quickly prioritize administrative support staff if a site is falling behind on their filing obligations. Further, metrics based on form fields from study documents, like time from site selection visit to start up and screened/enrolled enrolled/completed ratios, can allow for risk-based analysis of trends. Regardless of the data they describe, metrics provide near instant feedback that allow clinical trial personnel the positive reinforcement necessary to sustain long-term incremental change.

 

Contact LMK Clinical Research Consulting today and secure your TMF Summit one-on-one timeslot today. We look forward to seeing you on January 22nd and 23rd at the Sheraton Orlando Lake Buena Vista Resort!

Request a complimentary consultation.