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Is eTMF Implementation Really That Scary?

Madison Ramsay


In any situation, change can sometimes be scary. This can be especially true when contemplating a transition to an Electronic Trial Master File (eTMF) since you are accustomed to managing your Trial Master File or in some cases, a Trial Monster File - a certain way.

You may know that your current TMF management process is not the most efficient, but it is often difficult to allow yourself to contemplate changing the process after so long in that mindset.

This is particularly the case when implementing new software. Countless goosebumps and questions arise, and a number of fears bubble to the surface. How long will it take me to be trained on the new system? What happens to all my existing files and folders? How long will the transition take before I can resume my workflow? If these are nightmares that have kept you up at night as you look to move to an eTMF - be rest assured, you are not alone.

We understand that implementing new software can be a haunting task, but with the proper support, planning, and the right resources, your organization can transition to an eTMF. In the following article, we have outlined five key considerations that will make your deepest darkest eTMF implementation fears disappear and ensure you are moving towards the spooktacular solution - enter at your own reward.

Do your homework!



Before you begin eTMF implementation, it is imperative that you know what to expect throughout the process. Don’t be afraid to ask all your questions during vendor selection; How long does implementation take? What is the duration of the training program? What is the time and effort required of our internal team members? How long before we can commence working in the system? What do I need to survive the process?

Knowing what to expect before going live with an eTMF will reduce the shocks and trauma on every turn in the  eTMF maze of decisions, and help facilitate the transition. Below are five steps you can take while implementing an eTMF to make it a bit less daunting and de-bunk those urban legends!

Related Article: What is eTMF software? And Does My Organization Neet to Implement One?


Designate an internal implementation team



In any project, whether it be a zombie apocalypse or an eTMF implementation, you need a dedicated project manager to lead the way. Designate a project manager who will stand front line, carry the axe and act as the primary point of contact between your organization and the eTMF vendor. Your project manager will be in charge of project decisions, coordinating completed documentation and project metrics. Having a project manager to steer your team through the mist of an implementation will ensure the project is going according to plan and everyone comes out alive and stronger than before.

When dealing with enterprise software, it is also good practice to designate a technical lead – they are the brains behind the operation. Watch out for those zombies, and get this next team member on board. This person will most likely be someone in your internal IT team who can lead technical decisions and offer advice on technical subjects, so listen up - they know the way to safety. 

Your third essential team role is an internal Champion. It is human nature to be skeptical of change, and having an internal Champion who will manage the sometimes difficult situations that may arise from the dead during an eTMF invasion is critical to a successful implementation. A Champions’ primary role is to generate internal momentum and increase coven adoption of the eTMF. Often we see process owners or key stakeholders morph into this role.

Another great way to ensure acceptance and thorough understanding of your new eTMF system is to invite your proposed implementation coven to participate in the vendor selection process. They will sit through demos and calls with the vendor, giving them unfettered access to learning about the new eTMF system.

Related Article: Managing Trial Documents from Start to Finish in an eTMF Application


Be open to change

A positive and open mindset can help the process move forward faster and will be beneficial to you and your team. Be a good witch and be open and available to cast helpful spells and help build a business case rather than rejecting change and turning everyone into a frog. Approaching change openly and positively will not only speed up the transition, and make the spell work faster but it will also allow for fluidity and consistency when training other witches. The sooner you make your new system and processes routine, the easier it is to implement into your daily workflow and you can get back to flying around on your brooms with ease. Witch brings us to the next step…

Avoid copying your paper process into the electronic system



A good eTMF system is bolstered by automated workflow functionality or lifecycle management of documents and scrolls. Your TMF content will ultimately end up filed in the same destination as it would on parchment and ink, but the process it follows may not be the same. Organizations often think they can copy their paper process into their new system. However, this creates a considerable amount of additional workflow steps which can in turn into a bit of a haunted maze. A great example of this is signatures. In the paper world, we tend to sign away our souls at every step of the process to ensure we are demonstrating action and complying with the applicable regulations. However, an eTMF system can automatically track ownership, when actions are taken, and who performed each action...removing the need to sign your life away at certain spell-binding steps of the process.


Make sure all primary users are well trained on the software



Once you have configured the eTMF system to your organizational needs, it is time to get your team trained in the school of eTMF wizardry, hosted by Montrium. One of the most critical elements to a successful implementation is in how well your team is trained on the software. Without proper training, you leave your team with an incredibly powerful machine, without the knowledge of how to drive it. As with great power, comes great responsibility.

If your primary users are trained well before going live with the software, these witches and ghouls can then spread their knowledge to other key users of the system and begin training other departmental groups. This can be extremely helpful, especially as you will often find that not all ghosts will be able to attend the live demo and training sessions the vendor offers in this realm. However, this could be the very thing that brings them back to life.


Have all of your content ready for migration and onboarding




When first implementing an eTMF system, you will likely have to migrate existing studies and associated TMF files that exist in hard copy or file share, into the environment. Without proper planning, this can be time-consuming – especially if your scrolls are all centralized in another dimension or contained in other complex filing systems that may require time travel to access them.

It is important to have all your content that needs migrating, ready for transfer. Doing this preparation in advance will only speed up the migration process, allowing you to begin using the eTMF system immediately. Migrating content can also represent a significant cost without adequate preparation and organization of documents.


Final Considerations

Transitioning to an eTMF system is a great step in the right direction; one that will continue to add an incredible amount of value to your business. However, making that leap of faith can be overwhelming, especially for those clinical vampires, witches and werewolfs as many will struggle to change the way they operate initially (the fur and sharp teeth can be hard to get used to). It is important to note that these fears often fade after the team gets working in the system and they live to tell the tale.

If you are terrified about moving to an eTMF, reach out to one of our eTMF specialists. We can walk you through our process and make you and your team feel at ease about making that first step into the not-so-haunted eTMF forest.

Happy Halloween everyone!

The Beginner's Guide to Bringing TMF Management In-House 


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