7 Steps to Seamlessly Implement Clinical Trial Technology
This post is written by Amanda Korey and was originally published on pharmalive.com here.
In the past year, the clinical research field has been challenged to consider remote clinical trial technology solutions. Without these solutions, research efforts that rely on paper documents, on-site visits from monitors, and in some cases even on-site visits from patients, were at risk of failure given the pandemic environment.
Many of these solutions offer exciting benefits, but the adoption of new technology can be challenging. The hurdles impeding meaningful adoption increase exponentially when clinical research organizations are implementing multiple new technology solutions simultaneously, which tends to be the norm.
There are 7 key steps to consider to ensure a seamless and successful implementation of clinical research and remote site access technologies. The following roadmap not only fosters collaboration between sites, sponsors, and CROs, but also results in robust user adoption across all stakeholder groups.
If you want a downloadable version of this article that goes more in-depth, download our implementations guide here.
Seek Input and Define Success
The first thing you’ll want to do is identify each stakeholder group who will be using this technology. Seek input from representatives of each group:
- What is their highest priority for using this new solution?
- What are the goals and benefits they hope to realize?
- What are their concerns or fears?
From this input, define a set of metrics you will use to gauge the success of the implementation. Make sure your metrics are definitive, measurable outcomes. Gather any available baseline data at the onset of implementation, so you’ll have historical data for comparison down the road. Now that you’ve determined the priorities of your stakeholders, it’s time to get to work.
Configure Your Technology Based on the Input
Establish a “tiger team” of capable individuals. This team will incorporate your selected priorities into the actual technology configuration and ensure your technology vendor is aware of them as well. Refer back to these priorities when making key decisions during the implementation process to guarantee that all stakeholders’ perspectives are considered.
Transparency is key. Sometimes a strategic decision benefits one group over another. Sharing the considered options and explaining your decision can help to gain trust from all groups. Note: Your tiger team does not have to contain members from each end-user stakeholder group; however, the team should make decisions with each groups’ priorities in mind.
For example, say you are a sponsor implementing software to be used both internally and by your research sites. You don’t necessarily need to involve research site personnel in your software implementation, but do keep their stated priorities in mind as you move through the decisions required during this stage.
Communicate Ahead of Change
People don’t like to be surprised with new technology. Communicating an upcoming change to all parties is one of the most impactful ways to influence end-user adoption. While your tiger team is hard at work making critical decisions, get end-users excited by highlighting how this change will improve their day-to-day. This will vary for different stakeholder groups, so a savvy implementation project team will adjust the messaging to ensure it speaks to each specific audience.
Leverage champions among your stakeholders to assist with communications. People give more credence to information coming from someone who shares a common perspective. Recruit enthusiastic colleagues from your site, CRO, and sponsor teams to rally their troops. Your vendor should also be able to offer resources to assist with communication. It’s in their best interest for people to adopt this new technology, so don’t hesitate to ask about materials they can provide that will make your team’s job easier.
Announcing the impending switch to a new technology solution may be an appropriate time to acknowledge the fatigue from numerous concurrent technology implementations if this is a scenario faced by any of your stakeholder groups. It’s perfectly normal for people to feel exhausted when they initially consider the idea of learning yet another new program. They should also feel confident that you have kept their best interests in mind and will make this change as simple and painless as possible.
Train Users for Success
The most significant factor impacting adoption is training. During training, each end-user makes a personal connection to the new solution, and we all know the importance of a first impression! No single learning style works for everyone.
Videos are a traditional, scalable approach to training; however, many people tune out when their full attention isn’t demanded.
Offering varied modes of training resources can help your new users be successful, no matter their learning preference. Consider role-specific content and provide digestible amounts of information via video and written options, such as tip sheets or work instructions.
If you have the resources, virtual interactive sessions with super users from your implementation project team can be a powerful option. Your vendor should assist you in developing a comprehensive training plan that will ensure user adoption.
Roll-Out Your New Technology
Developing a solid roll-out strategy allows for effective training offerings by considering which user groups will start first and how the rest will follow.
Depending on the solution, launching a “pilot” group of users may be beneficial. This enables you to test your plan and adjust if necessary, before rolling out to a larger group.
The pilot group could be focused on a particular stakeholder group or may be composed of early adopters across multiple stakeholder groups. Regardless of who you select, communicate that they are a select pilot group and encourage their feedback.
Another option is to take the crawl-walk-run approach. This involves adopting a basic level of functionality during the initial implementation of a new technology solution, and then adding more advanced functionalities as your teams become more familiar with the program.
Determine Support Plan
Adopting a new technology solution will always bring plenty of questions. During your implementation project execution, determine which individuals will be part of the administrative team beyond go-live. A clear support plan will make life easier for this team.
Managing support and answering questions from multiple organizations and stakeholder groups is overwhelming when it is disorganized. Develop simple, clear steps to follow for each group when questions arise.
Call out which question types are most appropriate for the vendor and which are best directed to the internal admin team. Provide easy access to training materials for self-guided assistance and proactive reduction in end-user questions. Consider a specific support email address that multiple members of the admin team can monitor for cross-coverage.
Evaluate and Plan Next Steps
Once your stakeholders are up and running on the new technology solution, the work is done and you can close your implementation book, right? Wrong! Technology that enables sponsors, CROs, and sites to collaborate remotely and advance clinical research is often complex and requires continued collaboration to ensure all stakeholders see their intended benefits.
Your new solution should be evaluated over time by reviewing stakeholder feedback and making relevant adjustments. Revisit the metrics you originally established. Did you meet them? Do your stakeholders have changes or additions to the list? Does your vendor have suggestions to help you optimize your ROI over the next 6-12 months?
Looking Ahead
While this roadmap walks you through some key areas to consider before, during, and after implementing a new technology solution for remote collaboration, the most important takeaway should be the concept of partnership and collaboration among stakeholder groups. When developed together and adopted across your numerous organizations, new technology should positively impact the core shared value of advancing clinical research between sites, sponsors, and CROs.
About the Author:
Amanda Korey is the Senior Implementation Manager at Florence Healthcare, an organization focused on improving clinical trials by building technology that helps research sites, CROs and sponsors streamline complex processes and workflows. Over the past 8 years she has overseen the implementation of new software applications for more than 200 healthcare organizations, including clinical research sites, sponsors, and CROs. She is passionate about building strong customer relationships and representing the voice of the customer in future technology development planning.