You have decided to buy new software to boost efficiency, save time, and increase data quality at your clinical research site! But how do you go about implementing your new eSource, CTMS, or eRegulatory system?
Breaking your new system’s implementation into small, manageable steps will greatly cut down on stress and improve your chances for a successful launch. Ask yourself these questions throughout the adoption process to keep organized and ensure nothing falls through the cracks!
Who Will Be Using the System and Who Will "Own" the System?
Identifying who at your research site will most heavily be using your new technology, whether it be a new CTMS, eSource, or eReg system, will inform you as to who needs the most training. Be sure that these users are sufficiently supported and have a solid base understanding of the system before they delve into the more complex features. These users should be experts in your new clinical trial technology.
There may be a difference between the people who will be using the CTMS, eSource, or eReg systems daily and people, or person, who "own" the technology system. The "owner" of these systems may be the clinical research site owner, the director, or the decision maker who gave the go ahead to implement the technology. The owner may not be working with the CTMS, eSource, or eRegulatory system daily, but they should still have a basic understanding about how the systems work and some simple workflows-- enough information to be able to ask questions if they do end up having to work with more complex features!
What is a Realistic Timeline for Implementation?
After identifying who will be using the new system, think about timelines and goals for implementation. Be honest with yourself and your vendor about how much time you can invest into documentation, workflow re-works, and trainings-- this will impact how fast you are able to get onboarded and launched with your new clinical trial technology.
At the same time, be clear in your expectations and goals. Do you have a study coming up that you would like to have fully on eSource? Give your eSource vendor that information so they can work towards having you up in running in time for the first screening visit!
Work with your eSource, CTMS, or eReg vendor to come up with a plan that works for your research site so everyone is on the same page. Communicate any changes that may impact your timeline.
How Will You Migrate to the New System?
Now that you have framed a timeline for implementation, it is now time to dive into the details about migrating to your new electronic source, clinical trial management system, or eRegulatory system.
If you are launching a new eSource system, will you be starting eSource on all of your studies at once, or will you start in waves? Will you be converting any on-paper source studies to electronic source part of the way through? Will you be starting all new studies on electronic source and keeping all old studies paper? Talk about all of these options with your eSource vendor.
If you are launching new CTMS software, how will you get your patient database into the new system? Will you be moving all of your finances over to the new software? How will you track old payments if you are moving over studies that have already started? Are you going to move your entire calendar over to the new CTMS calendar? Again, work with your CTMS vendor to come up with a plan that is best for you!
What Are Your New Workflows?
Buying clinical trial software to make you and your team’s life easier is exciting! But how will it actually work in your day to day?
Coming up with workflows that work best for your clinical research site is another place where working with your software vendor is key. Pay close attention to the system trainings and be mindful of how you will implement those workflows in ways that will work best for you. Be open minded about these new workflows, as they are typically the most efficient way to use the new system, but also be realistic in what it will take to train your team!
Are You Compliant?
The last big question to ask yourself before launching your new eReg or eSource software is about compliance (CTMS is not typically applicable here). The first place to start with clinical trial software compliance is Part 11.
Part 11 is the governing body of eSource and eRegulatory solutions. It is what allows research sites to collect source data electronically. If your eSource vendor is not Part 11 compliant, you should not be using their system, as it could be a big issue if your site ever received a FDA audit. It is also a huge plus if your eSource vendor is GCP Compliant and HIPAA Compliant.
Bonus if they have evidence of third party validation!
It is important to note that while a vendor can be compliant, there is still documentation that must happen on "your end" to ensure full compliance. A good vendor will provide you with helpful compliance tools and validation exercises to ensure that everything is squared away.
Be sure to complete the system validation and have the correct documentation stored away before you fully launch!
Good luck with your new clinical trial technology!
Anna Krauss is a Project Manager at Clinical Research IO. She has experience in the health field through her work as a Research Assistant with the MaineGeneral Hospital system, Hospital General de Agudos Bernardino Rivadavia in Argentina, and through her experiences working as an EMT.