Selecting the right eRegulatory platform with the features you need is only half the equation; the other half is successfully implementing the platform at your research organization.

In this guest article, Yvonne Gorham shares her tips for successful eRegulatory implementations. Yvonne has over 20 years of clinical research operations experience and helped navigate the transition to Florence eBinders at Moffitt Cancer Center.

Yvonne’s 7 Tips for Successfully Implementing eRegulatory

Yvonne’s 7 Tips for Successfully Implementing eRegulatory


Communication is Key

“Share the vision and the plan early, often, and clearly to the teams and individuals that will be using Florence eBinders. In addition to sharing the organizational value, focus on how moving to eRegulatory will impact each individual.”

Florence Pro-Tip: Highlight how eBinders will not only save Physicians’ time but will make them more efficient in their day-to-day administrative duties. Winning the hearts and minds of PIs with simple explanations as to how this will speed not only study start-up, but ongoing Principal Investigator responsibilities is key here. This Investigator Adoption Best Practices Webinar guides you through how to get PI’s on board and efficiently using new technology.


Start Simple

“In collaboration with the Florence team, we created a quick and easy-to-read information sheet that included sign-on instructions for our team. We knew if we could get the PIs trained quickly, it would be a win for everyone.”

Florence Pro-Tip: eRegulatory platforms are robust and feature-rich. Choose the top 2 – 3 eRegulatory workflows you want each user or role to learn first and create learning resources for these first. Strategically plan your team’s introduction to all the eBinders functionality you want them to adopt.


Build Folder Structures Early

“We built our binder and folder structures in eBinders before training and going live in the system. This process enabled us to train on the way we were going to be using the platform, instead of generic training on the system.”

Florence Pro-Tip: eBinders offers Standardized Flexibility to fit the processes and preferences of each trial site, but with enough structure and standardization to ensure individual users will follow the appropriate steps.


Select and Empower Project Champions

“We selected people from each stakeholder group to serve as key Florence eBinders subject matter experts. We then trained them early and more in-depth than the standard user. These individuals were useful during initial roll-out and in the months following as a few people were available on-site at each location that could answer questions as needed.”

Florence Pro-Tip: The Florence Help Desk is available 24/7. While training and user adoption of your new eRegulatory platform is ultimately the responsibility of your team, leaning on your vendors for ongoing training resources is important to be able to scale adoption of the software.


Plan for Remote Monitoring

“During implementation, we created a specific process to give external monitors access to eBinders for the studies they monitor. Thinking about monitor access in advance meant once we went live, we had a standard process in place and could easily provide remote monitor access as needed.”

Florence Pro-Tip: Work with the Florence implementation team to create communication handouts as to training and attestation requirements. Remote monitoring is crucial to realizing the ROI of your software investment, so ensure this is a top priority as you move through the implementation process.


Focus on Roles and Permissions

“Take the time to plan your roles and permissions fully. Determine the levels of access ahead of time. For example, I had full access along with a few others, including the Regulatory Manager. Each of us had permissions that allowed us to remove and grant access to individuals. This model worked as we always had a back-up in the event someone wasn’t available.”

Florence Pro-Tip: The Florence implementation team will work closely with you on determining roles and permissions.

Successfully navigating technology transformation requires a strong change management plan. Download our Guide to Successful Change Management to build your strategy.


Meet Yvonne Gorham, CIM, CCRP, CLSSGB

Yvonne Gorham has worked in the clinical trials field for over 20 years. She previously worked at a Project Manager for Regulatory Start-up at Moffitt Cancer Center in Tampa, FL. She has vast experience in regulatory affairs and coordinating. She obtained her Clinical Research Professional certification in  2012 and her Lean Six Sigma Green Belt in 2014. She was a Navy Ombudsman for 8 years and still actively supports the military families. Yvonne is currently a Clinical Trials Coordinator at Axiom Clinical Research of Florida. Connect with Yvonne on linkedin here.