Going through the vendor selection process of any new software is an exciting and sometimes daunting task. Once you've got a good idea of what you're looking for and found a few options that fit the bill, you'll likely reach out to vendors to test drive their tools and have them demonstrate the software for your team.
Product demonstrations are often your first real glimpse at a new way of working. You'll be guided through the user interface, exposed to the different areas of the system, all with the ultimate goal of seeing how the tool will work within your organization. However, demonstrations can be more than just a show and tell. These sessions provide your team not only with the opportunity to see how a system works, but to dig deeper into some of the other items related to selecting a vendor. If they are not prepared for or managed properly, these demonstrations can spin off into tangents that are not of interest or related to your organization in any way and you could be left feeling like you've wasted your time.
As you progress through the vendor selection process for your Electronic Trial Master File system, ensure you are asking the right questions. To keep you on track we've listed out 10 essential questions to ask in an eTMF demonstration.
Is your system pre-configured based on the latest version of the TMF reference model?
What does the validation process consist of?
- What validation approach do you recommend?
- Does the system come pre-qualified (IQ & OQ completed)?
- Do you provide test scripts and templates to speed the validation process?
- Do I need to update any SOPs or documentation?
Is training included and if so, what is involved?
As you can imagine, having your users feel confident and competent in the eTMF system will beone of your primary goals. Poor user adoption leads to inconsistencies in your process, potential human errors and a wasted investment. You'll want to look for a vendor that put a focus on intuitive user experiences and comprehensive training to ensure your team go live with confidence. Here are some questions that will expose a non-customer centric eTMF vendor:
- How much training will I receive as part of the onboarding process?
- What resources are provided during the training sessions?
- Are training sessions interactive or user guide based?
- What happens when new team members join, is there on-demand training material?
- Do you have any self-guided certifications or courses we can take?
- Do your clients submit tickets through a web ticketing system?
- What is your support model and response times?
- Is support included in the fees?
- Is support provided only via email, or will phone and web conference be available?
Think of your use case and ask how this process would work in the eTMF system?
Every vendor has their own idea of an onboarding process and a go-live strategy. Deployment of a cloud environment might take very little time, but the difficult part is the onboarding. The scope of this could differ case by case but knowing what is included is imperative to a successful implementation. Training, validation, and other activities are defined differently depending on the organization, this is the same with the go-live date. Go-live may be defined as the day you finish training, or the day you have completed user acceptance testing. Make sure you are aware of what go-live means to your vendor and be sure that it aligns with your needs. Preparing this in advance will allow your organization to have a much smoother implementation process. And most importantly, set realistic goals. In a perfect world we would be trained and up and running in a week, but we still have day jobs and other tasks that get in the way. Implementation takes resources on both sides and setting realistic timelines and preparing in advance will go a long way on your path to eTMF success.
How does the solution provide access to users outside of my organization?
Product demonstrations are only as useful as you make them. Don't be afraid to make it your own and ask questions throughout the session, after all this demonstration is for your benefit. Always try to dive into as much of the system functionality as possible, you’ll be using this software every day and you need to make sure that it suits your needs as best as possible.