How to Assess the Health of Your Trial Management Operations

In the first post of this blog series, we explored indicators that your company may be ready for a new CTMS. In this post, we’ll help you gain insights into your current trial management operations, so you have a starting point to make a case for change for a modern CTMS at your organization. Here are a few ideas:

  1. Audit active tracking spreadsheets

    If your organization uses tracking spreadsheets, document the information hand-offs between teams and the time it takes to enter information in multiple places. This should provide clear evidence of which processes are inefficient and opportunities for improvement.

  2. Identify what metrics can’t be tracked due to data silos or poor CTMS configurations

    With the cost to bring a drug to market averaging around $2.6B1, access to study performance metrics and reporting becomes critical to identify issues and inform decision-making. For example, it’s imperative to have visibility to low-enrolling/no-enrolling sites to take corrective action and minimize impact to study timelines. If you can’t get that information quickly from your CTMS, you may experience operational delays.

  3. Identify high-impact business processes and highlight workflow failures, including manual workarounds

    Consider key processes managed in your CTMS, such as monitoring and issue management. Document all instances where manual intervention is required, then consider when downtime or CTMS system limitations affect your team’s ability to execute.

  4. Document where users are working outside of the system and the impact on information quality and operational efficiencies

    Consider the impact of working with an incorrect version of a document and the time it takes to manually file trip reports in the TMF. Look for areas where lack of document re-use slows tasks. Your CTMS should allow team members to see all information for an upcoming planned site initiation visit. Team members should be able to use combined data to prioritize which contract needs to be developed and reviewed, collect all necessary documentation for investigational medicinal product release, and ensure the monitor is prepared to conduct the study initiation visit.

  5. List examples of standard reporting requests and estimate the time required to compile the reports

    Think about the key reports and dashboards you continuously need, such as CRA monitoring reports, monitoring compliance metrics, study progress trackers, and risk evaluation. Can you run the reports and instantly get them from your CTMS, or does it require manual manipulation to get the data in the format you need? If you spend hours per week pulling reports, it could be time for a change.

For a deeper dive into your company’s current CTMS maturity and full ROI analysis, get in touch with us. In our next post, we will cover the value of a modern CTMS.

1. Innovation in the pharmaceutical industry: New estimates of R&D costs. Tufts Center for the Study of Drug Development. 2016.