Selecting an eTMF Vendor that Empowers Site Collaboration
Not all sponsors and CROs that select and implement an Electronic Trial Master File (eTMF) solve the bottlenecks and inefficiencies that the system was selected to target.
Why?
Often, during the vendor selection process, organizations undervalue the impact of vendor support teams, overlook critical implementation processes, and don’t fully understand the correlation between software capabilities and the bottlenecks they address.
The biggest challenge that ultimately affects how well an eTMF system performs is its ability to drive site collaboration and integrate with the tools sites are already using.
With over 10,000 research sites connected to the Florence Network, we understand the delicate relationship between the sponsor/CRO and the site and how a digitally integrated eTMF and eISF can significantly impact the overall success of a Clinical Trial.
To help guide sponsors and CROs through a smoother and more fruitful eTMF process, we created this article to address common friction points, such as:
- Selecting an eTMF Vendor
- Implementing an eTMF
- Site Collaboration
Download the Complete Guide to the eTMF to get an in-depth overview of how a modern eTMF solution can impact your organization, the compliance and regulatory system requirements, and the steps you can take to prepare for adoption.
Selecting an eTMF Solution
As you begin to evaluate and plan for an eTMF, it is essential to have a strong understanding of the capabilities you require to address the unique bottlenecks and inefficiencies at your organization.
Every platform is unique. However, there are essential assets you should look for that will enable you to realize the benefits of a modern, active solution. These are the core areas to focus on when evaluating a solution.
Core Features and Functionality
TMF reference model adherence or available variations, granular role-based access control, easy document filing, and indexing across all document types, robust, real-time reporting around completeness and accuracy.
Compliance and Validation
Make sure your vendor is compliant and supports:
- • EU – EudraLex Vol 4 GMP – Annex 11
- • ICH GCP E6(R2)
- • EU – GDPR
- • FDA 21 CFR Part 11
For an in-depth outline of compliance regulations and vendor compliance requirements, download the Complete Guide to the eTMF.
Implementation and Support
Robust and proven implementation support provides training not only to your eTMF users but also for additional role-specific and site-user specific training. The implementation process should also entail detailed guidance and support to SOP development and edits, integrations as needed, and other tailored professional services.
Site Collaboration
Connect to thousands of investigator eISF platforms and create simple site workspaces for real-time sponsor and site collaboration.
These are limitations to note when evaluating a solution.
- System Limitations – lack of integrations
- Lack of outside user access
- Inadequate QC process
- Lack of flexibility in TMF structure
- Non-global compliance
- Lack of site perspective and experience
Implementing the Modern eTMF to Drive User Adoption
It is typical for you to introduce the selected eTMF to all your clinical trial stakeholders for the first time during the implementation process. A disorganized process with little vendor support will negatively impact how broadly the new system is adopted, accepted, and utilized.
Widespread user adoption will largely determine how effective the system is at improving process efficiency, reducing redundant tasks, minimizing costly delays, and maximizing financial return on investment.
The two lists below outline the most critical do’s and don’ts of implementation based on field-tested practices of implementing technology for clinical trials at hundreds of sites.
What to do:
- Configure your folder and document organization according to your needs.
- Look for ways to standardize across multiple studies and sites.
- Inquire about best practice recommendations and templates.
- Consider a crawl-walk-run approach to assist in change management.
What not to do:
- Come out of the gate too hot; you run the risk of overwhelming your team which can hinder your success rate.
- Not expect your vendor to be committed to your success. You shouldn’t have to do it alone or rely on consultants.
We suggest evaluating each vendor during the vendor selection process to determine if their implementation support is sufficient to guide your team to success.
When planning the implementation process to transition your team from traditional paper and fragmented technology workflows to a fully electronic and purpose-built eTMF platform, there is a collection of best practices that create a conducive environment to ensure user adoption of the new technology.
Step 1: Build a Tiger Team
Recruit a small team representing different areas of the organization.Tiger team members will be the champions of the new software platform and be the go-to leads for internal stakeholders. Select individuals for this team that have strong skills in communication, project management, and troubleshooting.
Step 2: Run a Beta Launch
Keep a scorecard to track critical workflows and expose problems that may arise during the transition process. Testing your new system as often as possible and with as many processes as possible acts as a practice run for when the system is fully implemented and helps mitigate any potential issues before launching the system across the organization.
Step 3: Focus at First
Pick a small workflow, such as credential management, and require everyone to adopt it. Taking small, yet accountable, steps into software adoption can help reduce anxiety that often accompanies change. Allow tiger team members to help guide those struggling with the platform and increase overall user adoption.
Step 4: Validate Your Processes
Client-specific eTMF processes require validation outside of the typical implementation track. Build unique process testing into the standardized implementation track provided by your vendor, and work with your vendor to allow additional testing time. Testing processes that will be used organization-wide before rolling the system out is critical.
Step 5: Celebrate Your Success
Show off usage statistics to prove that the processes are working. Demonstrating to stakeholders that their hard work has paid off helps solidify the value of the new system and creates pride within your organization. These usage statistics also allow your internal teams to identify additional areas of improvement or maintain their top-performing status.
