The Recipe for a Perfect eTMF

Have you ever followed a recipe from a cookbook or your favorite foodie site and wowed family, friends, house guests, and/or complete strangers? Have you ever rushed through a recipe only to realize you’ve skipped steps and missed important details in the process? You probably ordered a pizza that day and spared your guests.

There are thousands of recipe books and sites because recipes work when you follow the recommended steps to a T. A recipe is just that: a list of recommendations based on the knowledge and experience of someone who took the time to figure out how to get it exactly right. If you are choosing an eTMF for your clinical studies, you need a recipe to guide your process for a predictable, successful outcome. Here are six steps to choosing and following your recipe:

Step 1 – Look for Established Recipes

You are going to trust the recipes from a cook who has a known history of making amazing food. Just last year a market report not only showed the incredible growth in the eTMF market but broke the market down categorically by component, deployment, end user, functionality, and region. In other words, product teams are increasingly refining their recipes to accommodate different palettes.

In the world of eTMF, it is important to look at systems that have been battle tested (around for at least five years). Has the product been around long enough to have lived through regulatory scrutiny, validation and use across many studies, and do users like it? Does the chef’s approach match your needs? If I am vegetarian I’m not going to pick a chef who specializes in meat. Likewise, you need to identify if the system is backed by relevant clinical experience and whether or not it provides the support your business needs, such as consulting and IT services. Does the system capture the nuances of process that align with your operations? Does it accommodate users on the go? A mismatch will leave a bad taste in the mouth of your users. In other words, don’t serve your vegetarian friend a cheeseburger!

Step 2 – Use Quality Ingredients

It goes without saying that natural foods are better for you than processed foods. The way something is made matters. Can you trust the process backing your system? It is important to verify that development of your eTMF follows a strict Software Development Life Cycle (SDLC) and meets global regulatory and security requirements, including 21 CFR part 11, ICH E6, GAMP 5, HIPAA, GDPR, etc.

ISACA (Information Systems Audit and Controls Association) states that on a finely tuned Agile team, risk is controlled by “promoting the visibility of risk, ensuring collective ownership and accountability in relation to risk, and supporting informed decision making in an environment that is often founded on people-centric principles.” Risk control is fundamental to Agile teams. As with cooking, sports, and most other skills, it’s all about the fundamentals. Don’t take them for granted.

Step 3 – Follow the Recipe Precisely

This takes us back to ordering pizza because we did not have the patience to follow the recipe. Once you’ve committed to a recipe, it is essential that you follow the steps outlined by your eTMF partner for implementation. Recipes are used over and over again because a successful chef took the time to get it right and spent years perfecting it. Trust the process!

An eTMF platform provider with enough years in the industry will know best how to help you get up and running. Always try your meal before you start adding salt and pepper. You won’t go into the kitchen and do better than the chef. Your best effort at business process analysis will not best the years of dedication from the product team of your vendor of choice. An article from CIO recommends that you focus more on documenting and rating your requirements, stating:

“One of the main reasons for software implementation projects exceeding budgets and schedules is the discovery of unknown requirements during implementation. Every time a new requirement is uncovered, that requirement must be evaluated for importance. If it is a showstopper, critical, or even very important and is not supported by the software, work around solutions must be developed and implemented. When this happens too often, the project is delayed, and costs exceed the budget.”

Companies can be so focused on managing the vendor during implementation that they get distracted from comprehensively capturing their own needs—that could ultimately facilitate better implementation planning for any product they select. Let your eTMF provider carry out their process and establish healthy communication to align their process with your needs.

Step 4 – Ask for a Tour of the Kitchen

Sometimes, for VIP patrons, a restaurant will give a tour of their operation. If you have purchased enterprise technology, you are a VIP. Don’t be afraid to ask for the tour. By tour I mean you want to learn about that eTMF while it is being set up and configured. Request a sandbox so you can begin testing the features before the process is complete. You can ask the team questions and get an idea of the flavors and subtle hints that will allow you to appreciate it even more once the eTMF is ready for consumption.

Step 5 – Plate the Food

Do not ignore the presentation. Once your eTMF is ready, the table is set. Make sure your team listens with attention as your e-clinical trainer reviews the configuration and takes you through the logical way you should approach learning the available features. Just like a tasting—where your server will tell you the order to best enjoy the samples—your trainer is there to help you best understand what is available to users to effectively work within the system. Don’t rush! You won’t experience all it has to offer and you certainly will not be able to fairly recommend it to a colleague.

Step 6 – Reuse the Recipe Next Time you Cook

Once you have successfully followed the recipe and delivered the perfect meal, do the same thing over and over again. Your eTMF should meet your requirements every time, for every study.

Here’s a summary of how to approach your eTMF implementation:

1. 1. Pick a vetted eTMF provider with at least five years of experience, a clear background of clinical expertise, and the supplementary support services that match your business.
2. 2. Make sure they have solid internal development, production, and IT practices (a strict SDLC) and adhere to all regulatory requirements (21 CFR part 11, ICH E6, GAMP 5, HIPAA, GDPR, etc.),
3. 3. Trust your eTMF provider to know how best to configure and deploy their product for you. Collaborate through information but let them do what they do and know best. They’re the chef!
4. 4. Request a sandbox to test the platform while it is being configured so you can become an expert on your technology before it goes live.
5. 5. Be attentive during the post-implementation training provided by your eTMF provider. How can you get the recipe right if you don’t pay attention to the chef?
6. 6. Follow your recipe every time you deploy an eTMF for a study to make the experience consistent. Make your meals predictably enjoyable.

Comply with the recipe above and you and your teams will have a ”Michelin star” eTMF experience!