Five Key Elements for a Successful Systems Implementation 

Over the past two years at JiT, I have contributed to numerous system implementations in various capacities. I have been involved in the vendor selection process, acted as the sponsor/lead, served as the SME, supported migration loaders, conducted validation activities, and, naturally, used the systems as an end-user. Drawing from these diverse roles and experiences, what are the critical factors for a successful system implementation? I believe, particularly in the context of inspection readiness, regulatory compliance, and efficient clinical operations, that adhering to best practices is essential. If you can focus on these five key elements, you are on the path to success! 

Executive & Leadership Support

Ensure that your executive and leadership teams understand and can visualize the business advantages the company will gain from the new system. Do they believe it will offer a competitive edge to clients and employees? Will the new electronic trial master file (eTMF) system enhance the collection of essential documents and promote good clinical practice, ensuring TMF inspection readiness? When this belief is in place, executive sponsors can champion the project through inevitable challenges. They will effectively allocate additional resources to support lagging tasks, make timely key decisions, and reinforce expectations during team meetings. They spread energy and excitement about what this change will mean for everyone involved. They are your cheerleaders! 

Cross-functional Representation

To ensure all perspectives are accounted for during the design and implementation phases, it is crucial to have a broad representation of groups in the project. This includes clinical trial stakeholders, quality assurance, and those who will directly interact with the new eTMF system and understand the reference model to support business requirements. Too often, business requirements are gathered without involving anyone from the business, or technical requirements are assumed without consulting the IT department. Although involving multiple stakeholders might lengthen the requirement-gathering phase due to the number of meetings, it saves time compared to redoing documentation and code/configuration updates. Conduct a stakeholder analysis to evaluate who will be impacted by the system and to what extent. This helps determine the level of participation and support for change management. Early inclusion and engagement will also increase ownership and the likelihood of the project’s success. 

Testing

To ensure the system functions as designed and maintains compliance, it must undergo thorough testing & have proper validation documentation. Develop a detailed test plan as soon as the designs are completed, focusing testing resources on the main functionality of the system. Avoid the common mistake of concentrating too much effort on complex features that will rarely be used. Assign end users to perform testing where possible; this will enhance their troubleshooting skills and, more importantly, make them advocates for the conversion. Ensure that the functionality used daily, for example the high priority tasks for TMF oversight, is working correctly.  

Change Management

Change management during a system implementation comprises two main components: communications and training. A robust change management strategy should include a stakeholder analysis, a communication schedule, a communications library, and various training programs. The communication schedule must align with the system’s go-live date, enabling you to build awareness, generate excitement, provide resources, and maintain engagement at the appropriate levels throughout the project’s progression. Typically, communication libraries cover timelines such as -2 weeks, -1 week, go-live, +2 days, and +1 week. 

For training, you will need at least two sets: System Administrator and End-User. Depending on the system’s complexity and functionality, additional training levels for various business users or Quick Reference Cards (QRCs) may be necessary to support users on Day 1. Training should be comprehensive, easy to understand, and accessible. Remember that hands-on end-user training is most effective when delivered close to the go-live date to ensure optimal information retention. 

Metrics/KPIs

Remember when I said the key to success was having the executive and leadership teams believe in the business advantage the company will gain? Now is the time to prove it. You can determine if the project was successful by measuring improvements in processes or positive changes in key performance indicators identified at the project’s outset. Defining baseline metrics before starting the project is essential, as they provide valuable tools for diagnosing problem areas. Keep the number of tracked items small, simple, and focused on the overall impact.  

For example, before implementing an eTMF system that leverages a consistent TMF structure and supports TMF oversight, measure how long it took to conduct QC on a new CRO’s compliance with TMF plans compared to the time it takes now for clinical operations to perform this QC. If the new system significantly reduces the time spent and offers advanced reporting capabilities, you have demonstrated a positive metric, thereby contributing to the success of your eTMF system implementation. 

There are many other items that can increase your success implementing a system, but I truly believe if you lead with a focus on these 5 key elements, you will greatly increase the system’s launch. 

~Ashley Bates, Sr. Director Consulting & Partnerships