How to develop an eTMF automation strategy

Over the past 10 years, the Trial Master File, or TMF, has transformed into a powerful and digital “Single Record of Truth” known as the eTMF. This transformation is the result of global industry collaboration, including the establishment of the TMF reference model.

But an eTMF is not a clinical trial automation solution. Think of it more like a highly organized electronic file cabinet. When we talk about eTMF automation, we are talking about automating all the manual processes that move essential documents back and forth between the trial sponsor and the site investigators. The eTMF is the final resting place for all those documents.

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, it takes a lot of human effort to keep essential documents organized during a trial. 

To truly automate an eTMF, a sponsor must commit to a paperless system for essential document collaboration and archiving. The following are the four most common automation strategies. 

AUTOMATION STRATEGIES

There are a number of strategies for automating the flow of documents from study start-up to study closeout. The following is a list of eTMF automation strategies we have observed by meeting with clinical research organizations:

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

The strategy your organization chooses depends on a number of factors. For example, waiting to see if new automation solutions are delivered by your eTMF vendor would postpone your 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. 

Building in-house software has some advantages, including more control over the software requirements and eventual ownership of a finished system without the need of 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.

Organizing a team to evaluate commercial software solutions is a great strategy for a number of reasons. First of all, by watching a demonstration of commercial software, you gain insight into the dozens of ideas that previous clinical trial sponsors added to the product over the years. Secondly, you can view commercial software as a viable alternative to any other strategy if the product can save your organization money, improve your service level to sites, and organize the flow of documents to be audit ready at all times. 

Even if your organization is determined to build custom software, a deep dive into a commercial version can help clarify your technical teams understanding of the project they are taking on.

The following are some examples of automation goals. These goals are important because they support the business case of the project.

AUTOMATION GOALS

To complete a transformation to a paperless system must address clinical trial collaboration challenges between sponsor and site, and where possible, automated. The following 5 goals are examples that have value to our customers, your organization may have different goals or additional goals.

  1. Digitize clinical processes with sites, to increase trial productivity and document quality.
  2. Track site documents in real time throughout the study lifecycle
  3. Understand the optimal use of human resources during a trial
  4. Give eTMF owners visibility into completeness gaps
  5. Enable real-time quality checks that ensure inspection readiness

CHALLENGES TO AUTOMATION

There are lots of challenges to complete automation. It is important to articulate as many of these challenges as you can gather from project stakeholders.

  1. Site-specific, country-specific, regulatory specific “document workflows” must be included
  2. CRA’s should become “Cultural change agents” and show site investigators the better way
  3. Global harmonization of disparate local processes
  4. Establish a cross functional team to ensure success of the project

CONCLUSION

There is no doubt that every large organization needs an eTMF automation strategy. There is no way to stay in control of hundreds of thousands of eTMF artifacts without automating the flow of essential documents on their way from sponsor to site, and from site to sponsor.

At InnovoCommerce we believe every organization should review our product in their conference room. Regardless of which strategy you choose, a deep dive into our commercial software will give your team the clarity they need to make an eTMF automation decision.