Conference Recap: ExL Pharma’s TMF Summit

February 13, 2013

  • eTMF Events

With the threat of snow looming, the attendees of ExL Pharma’s TMF Summit wanted to squeeze every moment of learning opportunity available at the January conference. The theme of this year’s conference, “Improving Quality in your TMF Documentation through a Compliant Centralized Filing System” set the stage for many of the discussions over the two days. Through discussions of best practices from top pharmas, CROs and vendors, I as an attendee concluded that an eTMF project succeeds when the people, process and technology work well independently and as a whole.

People

When choosing to move from a paper to electronic system, or when selecting an eTMF vendor, it’s important to think about who will be using the system.  Will your sponsors require or expect real-time access to the eTMF? Will your CROs and outsourced partners upload documents directly into your eTMF system? Can your CRAs access the system remotely? What will regulatory authorities expect when conducting an audit? It’s important to select an eTMF system that has the features your people need to succeed.

 

Process

You have to treat your eTMF like a major project.  Assign a project manager, then plan, execute and monitor progress.  Also, dedicate a significant amount of time to getting your structure right.  Without good planning and organization for your master list and other metadata, you won’t get any useful metrics from the system. You need to make decisions based on the regulatory authorities of what documents will require wet-ink signatures when to keep hard copies of documents.

Technology

Lastly you have to due your due diligence to figure out what technology works best within your organization.  Your eTMF should be solving a business problem, not an IT problem, so work with vendors to ensure that the eTMF offering is meeting the needs of your business.  You want to look at the long term processes and goals for your electronic trial master file, and let technology features be an added bonus.  Lastly, when choosing a technology, don’t think of an eTMF as a cost reduction strategy; you might not save money right away. Rather, your eTMF is a source of cost avoidance since proper usage will allow your company to sail through audits and cut down on retrospectives fixes, and significantly decrease your time to ship drug.