Are You Keeping Your TMF Resolutions?

January 23, 2013

  • eTMF Best Practices

As we come into the closing days of January, it’s important to review those resolutions we made at the start of the new year.  I know one perpetual promise reappears on my list every year: Be More Organized.  Organization and planning seem to hold the keys to guaranteed success, but getting there isn’t always easy.  Luckily, today’s technologies offer solutions to streamline the process.  With iPhone aps and other services, I’ve been able to plan my year so that I can effectively make decisions regarding my business schedule, budget and travel plans for 2013.

Putting a little bit of time and effort into a plan for a TMF, all in a centralized electronic location (your eTMF) produces similar outcomes.  While your current TMF might function sufficiently as a document repository, a well-oiled modern eTMF has the power to increase productivity and enhance clinical trial performance.   Here are three examples of how an eTMF with advanced planning and organization features provides business process improvements for your organization:

  1. Simplify study startup: You can use an eTMF to plan each study and define an expected document list.  With an automated process for this, study managers can answer a series of questions to quickly build their lists for each study, streamlining the study startup process.  Lists for countries and sites can be populated in the same way, and integrations with other systems, like CTMS can pull important data to automatically populate information about trials, sites and investigators.
  2. Eliminate the excess: Notifications and automated processes free your employees to complete more value-added activities.  With electronic workflows, documents easily pass from one step in the QC process to the next in real time.  Since the required documents for a study are clearly defined in an eTMF, study managers no longer have to create offline spreadsheets to track expected documents, or those who are responsible for them.  With thousands of documents needed in the eTMF, saving even a few minutes per document results in major overall time savings.
  3. Identify and address inefficiencies: In an eTMF, you can instantly see which documents are in your system, which are missing and which are coming due or past due; therefore, you can identify documents that might cause milestones to slip before they cause delays in your processes.  An eTMF also simplifies collaborations between sponsors and CROs, since one party can have instant monitoring access to the other’s progress.