He’s off and flyin’ as he guns the car around the track

He’s jammin’ down the pedal like he’s never coming back

Adventure’s waitin’ just ahead!

Go Speed Racer!

Go Speed Racer!

Go Speed Racer gooooo!

Readers of a certain age will recognize the theme song to Speed Racer, a cartoon from the late ’60s. The lyric and melody seem to live permanently just under the surface of my consciousness; no doubt seared into my hippocampus by sitting cross-legged three feet away from a console television every day after school between 1st and fourth grade.

Once again, it is playing in my ear as I think about this topic – implementing a Trial Master File software solution (eTMF solution). That is because when it comes to an eTMF deployment, speed to production matters greatly in driving value.  And the enemy of speed is complexity.

The Problem with Early eTMF Solutions.

Most of the eTMF systems available have, like Speed Racer, been around for a long time. They are based on platforms and designs that assume the organization will want to customize them to their own processes. Early customers were very large organizations that tend to feel that software systems should adapt to them, not the other way around.

But here is the reality. For the vast majority of organizations, you should try NOT to customize an eTMF application excessively.  Because customizations cause complexity, and complexity wastes time and money.

Frankly, an eTMF solution does some pretty basic things, and everyone knows what they are:

  • Create a study based on the TMF Reference Model;
  • Allow users to load documents with generated names that correspond to the model;
  • Put each item through a review and approve cycle; and
  • Meet the requirements of the Health Authorities for things like eSignatures and Audit Trails.

So the question is, do you need to customize the heck out of an application that does those things?  Do you need to go through requirements workshops, confirm the processes, design the processes, configure the system, and then test all the things you changed?

In an eTMF, Complexity Creates Cost

For a basic system like an eTMF, less is more, at least when it comes to customization and complexity. Because complexity creates costs. Here are some of the ways it does so.

Complexity Requires More of your Team’s Time. 

Many eTMF vendors will set your expectations that deployment into production and use of their application will take months. The reality is often worse because many actual deployments reach six months in duration. The vendor will require you to work through requirements sessions and design reviews. And every one of those days in deployment costs real money for your team’s time spent in workshops, review sessions, and testing.

Complexity Drives up Costs of Testing and Validation. 

The more complex a system is the more scripts required to test and validate it. And customizations require new, custom scripts, which of course, take time and resources to develop.

Complexity Creates Delays and Drives up Opportunity Costs. 

Every day in deployment activities is a day the solution is not being used, which means the reasons you want the system, such as saving time and resources in managing TMF documents, are not being realized.

Complexity is the Enemy of Adoption. 

While an eTMF solution with enormous options seems attractive, in reality, it is intimidating to users. When the process for reviewing or approving an item in a system is complex, users avoid it. They forget how to do it. Ease-of-use, which comes with effective design and reduced complexity, ensures higher and faster adoption, which accelerates the timeline for realizing the system’s benefits.

Implementing an eTMF? Do Like Speed Racer.

When we decide we want a system and we select that system, we want it now. A generation ago, a six month or longer deployment project may have been normal and acceptable. Today, it is not. Our organizations are populated with Millenials, and they expect to access an application on the web and start to use it immediately.

We are not quite there yet — in my own experience, the fastest deployment of an eTMF solution has been two weeks from day one to production — but we are getting awfully close. And if like Speed Racer, you want to “Jam Down the Pedal” on our implementations, you need to:

  • Select a cloud-based system and ensure it is a true SaaS system, with the same code used by every organization (because that accelerates validation).
  • Make sure it is based on the standard TMF Reference model.
  • Check to be sure it meets your basic functional requirements.
  • Commit to making the required configurations for access, workflows, and file naming, but resist the need to make customizations.
  • Check with real customers on their implementation experiences with your selected solution.
  • Do Not work with a vendor who has an incentive to extend the project based on hourly services charges.

Ultimately, if you do these things, you can reduce the complexity of your TMF solution, save time, save money, and get the highest value from the system. Because when it comes to an eTMF solution, we should all do like Speed Racer.

If you want to talk about your requirements and how we can help, give us a shout.

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