Is eTMF implementation really that scary?

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 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 especially true when implementing new software. Countless questions arise, and a number of worries bubble to the surface. What happens to all my existing files and folders? How long will it take me to be trained on the new system? How long will the transition take before I can resume my workflow? If these are questions that have crossed your mind as you look to move to an eTMF, rest assured, you are not alone.

We understand that implementing new software can be a daunting task, but with the proper support, planning, and the right vendor, your organization can transition to an eTMF with ease. In the following article, we have outlined five key considerations that will reduce eTMF implementation anxiety for your team and ensure you are up and running with the least friction possible.


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?

Knowing what to expect before going live with an eTMF will reduce surprises and in turn help facilitate the transition. Below are five steps you can take while implementing an eTMF to make it a bit less daunting!

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


Designate an internal implementation team

In any project, you need a dedicated project manager and eTMF implementation is no different. Designate a project manager who will 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 implementation will ensure the project is going according to plan and steer the timelines effectively.

When dealing with enterprise software, it is always good practice to designate a technical lead – he/she is your next team member to get 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. 

You 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 during eTMF adoption is critical to a successful implementation. A Champions’ primary role is to generate internal momentum and increase employee adoption of the eTMF. Often we see process owners or key stakeholders take this role.

Another great way to ensure acceptance and thorough understanding of your new eTMF system is to invite your proposed implementation team 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

This consideration is often overlooked, but a positive and open mindset can help the process move forward faster and will be beneficial to you and your organization. Be open and available to your team and help build a business case rather than rejecting change from the onset. Approaching change openly and positively will not only speed up the transition, but it will also allow for fluidity and consistency when training other users. The sooner you make your new system and processes routine, the easier it is to implement into your daily workflow. Which brings me 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. Your TMF content will ultimately end up filed in the same destination as it would on paper, 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 complicate the process and make the workflow more complex. A great example of this is signatures. In the paper world, we tend to sign 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.. This removes the need to sign at certain 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. 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.

If your primary users are trained well before going live, these colleagues 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 members of the team will be able to attend the live demo and training sessions the vendor offers.


Have all of your content ready for migration and onboarding

When first bringing in 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 system. Without proper planning, this can be time-consuming – especially if your documents are not all centralized or contained in other complex filing systems.

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 as you grow. However, making that leap of faith can be overwhelming, and many clinical teams will struggle to change the way they operate initially. It is important to note that this anxiety and difficulty often fades after the team gets working in the system and all of that hard work will have been worth it.

If you are anxious 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 in the right direction.

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About the Author: Katherine Cianciarelli

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