Over the past 10 years, the Clinical Trial Master File, or TMF, has evolved into a powerful and digital “single record of truth” known as the eTMF. This evolution of the eTMF was driven by the industry’s practical need to digitize all the essential documents of a clinical trial. 

An eTMF itself is not an automation solution for managing essential documents. Think of eTMF as a highly organized electronic file cabinet. Even if you assign users rights to upload, approve or reject document versions, essential document workflow is still missing. Most eTMFs cannot track a document’s history, its edits or any collaboration around each document. That leaves the entire essential document workflow in manual mode without an automation solution.

Why is eTMF Automation Important?

eTMF automation represents an opportunity to cut millions of dollars in expense while ensuring that clinical trial regulations are followed with technological precision. When we talk about eTMF automation, we are talking about automating all the manual processes that move essential documents back and forth from the first site startup of a trial until the study is closed. eTMF automation must support digital document exchanges between the trial sponsor and the trial investigators. 

eTMF automation workflow begins with a premise that there shall never be more than one copy of a document, regardless of the status of a document, or the number of collaborators that are involved. In an automated workflow, documents are not downloaded or uploaded by users. Instead, users work together in an online portal designed for clinical trial collaboration. 

Automation improves trial speed, CRA productivity, site satisfaction, and provides a perfect audit trail of documents on their way into the eTMF. Automation also enables sites and sponsors to fulfill regulatory requirements that require sites to maintain their own TMF that mirrors the sponsor’s eTMF but keeps patient data hidden from the sponsor. 

A typical study can involve millions of documents, hundreds of sites, weeks of collaboration, multiple revisions, eSignatures, wet signatures, complicated regulatory requirements, and many associates to manage the tons of paper that all end up in your eTMF. None of these processes require paper documents in today’s world.

4 Strategies to Automate your eTMF

There are 4 possible strategies you can consider to automate the complex and essential document workflow of a clinical trial. 

  1. Wait and see if your eTMF vendor develops an automation product in the future
  1. Build in-house software customized to meet your company’s specific needs
  1. Contract with a large consulting company to lead the project and develop a solution
  1. Organize a project team to evaluate commercial software solutions

The Wait and See Strategy: Waiting to see if new automation solutions are delivered by your eTMF vendor will protect you from making a wrong automation decision today, but it won’t help you solve challenging compliance hurdles that are trending toward more auditing of essential document compliance in eTMFs and ITMFs.

The Build In-house Strategy: Building in-house software has some advantages, including more control over the software requirements and eventual ownership of a finished system without depending on a software vendor. But a disadvantage to this approach is that it could end up costing more money than commercial software and not provide the same product maturity a commercial product can provide.

The Consultant Strategy: This approach is most effective when your goal is to transform your business processes and redeploy human capital to become more productive and therefore more competitive.  Consultants offer their clients the opportunity to rethink organizing people and processes. They are capable of making recommendations that should put your company on par or ahead of the competition. On the other hand, over the last decade, the number of consulting companies that specialize in creating software solutions for their clients has declined. More often than not, the technical and business challenges of a large company are mature and need only a little fine-tuning, not reengineering. Licensing commercial software has become a standard approach as companies try to avoid “reinventing the wheel”.

The Commercial Software Strategy: Organizing a team to evaluate commercial software solutions is a great strategy for multiple reasons. By watching a demonstration of commercial software designed to support eTMF automation, you gain insight into the dozens of ideas that other clinical trial sponsors have added to that product over the years. Additionally, you can view commercial software as a viable alternative to any other strategy. Look for a product that can save your organization money, improve your service level to sites, and always allow documents to be audit ready. 

What Exactly Gets Automated?

Specific regulatory requirements must be adhered to during a clinical trial and essential document requirements can get complicated. An eTMF automation product must at a minimum automate the following document processes:

  • Assemble and distribute the correct study startup package to each site, regardless of country, language, or local requirements.
  • Support each document’s essential workflow requirement without the need to download or print any required document.
  • Create a clinical site TMF that mirrors the sponsor’s eTMF and protects private patient data from being reported to the sponsor.
  • Distribute safety reports to every applicable trial site, collecting acknowledgement electronic signatures from those sites where it is required
  • Replace the current trial Protocol with an amended protocol document, collecting acknowledgement statements from every site.
  • Convert a site’s paper documents with wet signatures into digital documents without the need for a scanner.

Conclusion 

Each essential document has specific requirements for sending, receiving, acknowledging, collaborating, signing and storing. Moving those documents back and forth using postal mail, fax machines, or email messages is not automation. No matter how efficient your manual processes might be, in a manual system of SOPs, it requires a lot of human effort to keep essential documents organized and moving forward during a trial. Time, money and frustrated clinical sites make manual processes undesirable in a modern clinical trial.

InnovoCommerce has worked with several of the top 10 pharmaceutical companies for the past 7 years to design and build a commercial software solution that fulfills all the requirements of eTMF automation. Our product, the Study Collaboration Portal, plugs into any commercial eTMF system, and gives it the power it needs to automate its essential document workflow. Regardless of which strategy you choose to automate your eTMF, a deep dive into our commercial software will give your team the clarity they need to make an eTMF automation decision.