CBI Scene Blog

What to Consider When Implementing an eTMF – And What Vendors May Not Tell You

Posted by Lance Converse on Apr 23, 2014 9:23:00 AM

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Over the past several years, some sponsors and CROs implemented their eTMF without considering the impact it had on study teams, regulatory/compliance/IT groups, CRO partners and sites. In most cases those quick decisions resulted in extra manual processes, more double (or even triple) data entry, critical mistakes, extended implementation timelines, frustrated end-users, and escalated costs. While early adop
ters should be applauded for pioneering the use of these important solutions, many are re-evaluating their original decisions and moving toward next generation eTMF solutions.

By following a few simple guidelines and suggestions, sponsors and CROs can avoid these costly errors. This post isn’t intended to be an exhaustive list of features or considerations in your decision making; it is a list of important items that will help your eTMF selection decision look smarter to your management and end-users in the long run.

Move to the Cloud

Most leading eClinical vendors have been in the cloud for a decade and it will provide you with significant advantages in implementation timelines, features/functionality, and cost. Most companies are moving away from on premise eClinical systems and moving to next-generation cloud-based systems. This allows sponsors to cost-effectively manage the system for a global audience and administer access rights to CROs/vendors/sites without disrupting internal access control systems within their firewalls.

Configurability & Scalability

Pick a solution that YOU can configure and one that is scalable to support tens of millions of documents and thousands of workflows. You need a solution that is simple for you to configure - or you may be held hostage by a vendor to make changes for you… which takes extra time and cost extra money. You want a solution that you can configure in 10 minutes, make study-specific configurations (like adjusting QC thresholds by document type) and launch a few minutes later.

Bulk Processing & Intelligent Routing

You need a solution that supports bulk processing (uploading and QC) as well as intelligent routing from a variety of sources. Imagine having to upload documents into your eTMF one-at-a-time, adding meta-data to each document, and then routing it for QC review.  That doesn’t seem like a lot of work during the vendor demo, but when you have to process 25,000 documents for each study, and you work on 4 studies at a time, that is a LOT of manual processing. You want a solution that can receive documents by any modality; Bulk uploading, automatic routing from a Clinical Trial Portal, Faxing with 2-D bar-coded cover sheets, and/or by scanning with intelligent routing. The solution should support any and all of these routing modalities for a single study and across studies.

Consider a Platform vs. a Point Solution eTMF

An eTMF is considered to be a “point solution” in our industry, but the documents that need to be maintained within the eTMF come from many other solutions or places that are not integrated with the eTMF. Select an eTMF that is part of a platform solution and is integrated with other workflow applications for study start-up, training, site monitoring, safety letters, labs, EDC, IVRS, etc. This will automate the retrieval of data and documents reduce manual processes, cut down on triple data entry, and save you from a lot of mistakes. This also centralizes task management/completion, document management, data management and reporting through a single-sign-on platform for study teams, vendors and sites.

How will the eTMF be externalized to Sites?

Some companies suggest they can externalize the eTMF to sites, but have they done it on multiple, global studies? Or has it been a single pilot? How did the right documents get to the right sites/users in each country?  How did the document collaboration and approval process happen? These are the questions you need to ask during a live demonstration. This global document distribution is a complex process that is greatly underestimated by newer vendors in the market. Look for a solution that can quickly (in minutes) be configured for 20-30 countries with automated country-specific workflows with auto-populated document distribution, document collaboration, digital signatures and automated routing to the exact section of the reference model - with no printing, scanning, uploading or manual processes required. Remember that each country has different document types, with different document workflows and statuses depending on the sponsor, type of study, phase of study, type of sites, and EC/IRB requirements (to name a few).

Consider Short & Long Term Pricing

Short term pricing will be the cost of the eTMF when it is active on your study – that normally includes a set-up fee and licensing fees. The long term pricing would be the cost of maintaining the eTMF after the close of the study. This includes the migration of documents out of the eTMF or just archiving them in place in the eTMF and removing access rights - until required (i.e. audit). This is especially important as more studies are brought onto the system over five to ten years.

Happy eTMF Hunting!

Want to learn more about eTMF implementation, join us at CBI's 2014 eTMF Forum, taking place November 18-19, 2014 in Philadelphia, PA.

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Topics: Clinical