Tips for a successful clinical research software implementation

It’s clear that remote work is here to stay. For industries like healthcare that have historically relied on in-person interactions and paper-based records, this means implementing new digital solutions to remain competitive. 

But the clinical trial industry is highly regulated and involves managing secure patient data. That means the software implementation process requires an experienced team who can help you set up integrations, establish roles and permissions, and train your users. 

After leading both small and large teams through hundreds of healthcare software implementations over the past decade, I’ve put together my top tips that will ensure high user adoption rates and a low risk of compliance errors for your clinical research team. 

And after you finish reading these tips, check out our study start-up checklist for digital clinical trials.

1. Assemble your dream team

Who needs to have a voice in the decisions you’ll make regarding the configuration and day-to-day use of your software solution? We recommend: 

  • System admin users
  • Representatives of each stakeholder group who will use the software
  • At least one IT representative
  • One or more champions who can help encourage buy-in from resistant end users

It’s important to make sure that every person on this list can devote the time and effort needed to make implementation a success. Choose people who can set aside a few hours each week until the implementation is complete and who are eager to learn. 

Extra tip: If more than 10 people come to mind, consider having a small core team who meets regularly with the vendor and a larger team who meets separately to stay up-to-date on project developments and provide feedback as needed.

2. Start with a realistic timeline

Speeding through implementation as fast as possible may sound appealing, but it can set you up for a disastrous “go-live”–the point in time when everyone at your company who needs the software officially starts to use it. 

Your vendor should be able to provide a reasonable timeline estimation based on the specifics of your project:

  • The size of your organization
  • How many sites you’re working with (if you’re a sponsor, CRO, or site with partner sites) 
  • Number of studies you need set up
  • Any special features or integrations being implemented

If your situation requires moving faster, communicating the “why” to your vendor and project team might help inspire some creative efficiencies–but be sure it’s necessary. 

When you rush through an implementation, you may overlook details that will ensure optimal configuration and successful end-user adoption. You want every member of the team who needs the software to understand and adopt it. Good change management is essential when adopting new software.

3. Communicate about the software change early and often

Change is hard! People tend to respond better when they have time to mentally prepare for it. Find various ways to tell end-users that you’re adopting new software:

  • In-person conversations
  • Email reminders
  • Staff  meetings

Explain how the new application will benefit users and listen to their concerns about potential challenges. Lean on your change champions to build anticipation and gain buy-in.

Extra tip: An online change management certification (like this one) can equip you with some great resources to address this key component of implementation!

4. Look for integration opportunities within your technology portfolio 

At this point, your teams are probably using numerous digital solutions in their day-to-day work. 42% of sites log into more than 6 platforms for an average study, and 40% of sites say lack of integration is a barrier to technology adoption. Integrations let you log into a single platform to do your daily work and avoid entering the same data into multiple systems. 

Software with an open API is more likely to offer integrations. When software vendors have an open API, they allow other vendors to build software that integrates with theirs. That means research organizations aren’t forced to buy all of their software from a single source. 

5. Know your organization’s requirements  

Familiarize yourself with any software implementation and validation requirements in your organizational policies, or add someone with that knowledge to your dream team. That way, you can work closely with the software vendor to ensure those requirements are met.

It’s also beneficial to have clarity among your stakeholders about which project deliverables are critical and which are nice-to-haves that could be addressed later if they’ll put your implementation timeline at risk.

6. Define success and gather baseline data now

At the start of implementation, document how your stakeholders define a successful implementation. The best success metrics are definitive, measurable outcomes, such as the time required to obtain electronic signatures on documents. 

Gather any available baseline data from the current state (pre-implementation) to ensure you have historical data for comparison after you are live with your new solution.

7. Proactively address common project-specific challenges 

Your vendor has likely seen common areas of implementation where customers run into challenges, perhaps related to access configuration or workflow decisions. Ask them for insights early, and make plans to prevent these problems as you proceed through implementation.

8. Be adaptable with your project plan 

As you get into the details of your implementation, you may realize you need to change your project plan to overcome challenges and meet your criteria for success. You shouldn’t leap into changes, but an adaptable team will achieve greater success than one who refuses to make changes when obstacles arise.

9. Know how your vendor will support you  

Your software vendor has undoubtedly assured you that there are channels for support when you need it–but dig deeper.

Do they value your relationship as a business partner? Will they offer opportunities to check in after go-live? Will they provide suggestions to increase adoption down the road? How will they support you if and when an issue arises – do they link arms with you or leave you to handle it on your own?  

In addition to live chat, email, and phone support, Florence offers online guides and videos, so you can choose the form of support that works best for you.

10. Offer training options to accommodate diverse learning styles 

People learn in different ways. Try offering training resources in multiple formats: 

  • Written materials, such as articles and one-pagers 
  • Videos
  • Live sessions, both in-person and virtual 

All of these resources can play a role in successful end-user adoption.

How to Have a Successful Clinical Research Software Implementation

Implementation lets you move from the exciting yet stressful process of buying new software into using the software on a daily basis to make your clinical trials more efficient and compliant. You deserve a team who’s knowledgeable, flexible, and prepared to be there for you every step of the way.

Florence specializes in the implementation of eISF, eTMF, remote connectivity, and eConsent software. For more about implementations, check out our Ultimate Guide to Successful eRegulatory Implementations.

About the Author

Amanda Korey is the Senior Implementation Manager at Florence. She has extensive experience in the healthcare and software sectors, having worked in the clinical practice, biotech, and EHR industries. She is passionate about enabling healthcare organizations to implement software solutions that improve the experience for both patients and healthcare professionals.