Choosing a Successful Clinical Trial Management System [CTMS]

Steps towards a successful CTMS:

Exploring the benefits of clinical trial management system (CTMS)

The benefits of mapping and developing an enterprise wide solution include6:

  • Centralizing decentralized departments
  • Optimizing institutional review board (IRB) functionality
  • Realizing real-time data available to both investigators and leadership
  • Decreasing bottlenecks in knowledge transfer between various entities involved in research
  • Reducing human errors in reporting that often cause compliance issues
  • Tracking milestones for grants, awards, fellowships, etc.
  • Streamlining the financial structure — billing and invoicing

operational, infrastructure, compliance, and governance issues that can be improved by implementing a CTMS:

  • Staffing: with a better understanding of resources, management will be capable of reallocating staffing assignments to offset excess or inadequate roles.
  • Communication: improved communication will improve patient satisfaction and monitoring of clinical trials.
  • Human error: CTMSs have integrated checking components to limit errors in reporting.
  • Operational flow: improved knowledge flow in various divisions (finance, marketing, administration, training, and recruitment) will help to achieve real-time results and data.
  • Managing clinical data: more accurate and efficient reporting tools will be useful internally and externally for current and future project assessments.

 

Choosing a CTMS that serves your institutional needs

ctmsEven though there is no perfect system, consider the reviewing of some common elements among most of the best systems:

  • Financial reporting tools (coverage analysis, residual and overage reporting)
  • Clinical trial management tools (including applicable clinical trial milestones and reporting dashboards)
  • Searchable clinical trial database
  • Analytical risk-based decisions
  • Reporting dashboards
  • Data warehousing module
  • Recruitment support module
  • Electronic case report form (eCRF)
  • Integrates easily with electronic medical records (EMRs), IRB system(s), etc.

Cost factors and implementation overview

In our experience with the implementation of CTMSs, the following are key aspects of the process:

  • Building a steering committee: the most important aspect of implementing a CTMS is having a committee that is capable of making well-informed decisions for the institution.
  • Forecasting future issues: know the current and future issues of the institution that hope to be resolved with the CTMS.
  • Adapting to change: understand that implementing a CTMS will come with new responsibilities. The institution should be prepared to have individuals fill these new roles. Without this preparation, the CTMS is doomed from the beginning. New hires might not be necessary, but rather a shift in responsibilities. Create a culture of transparency to eliminate conflict and inconsistencies in the future.
  • Training and preparation: design an ongoing tailored training program to meet the short- and long-term needs of staff.  Implement training and train staff on the new technology.

A successful CTMS connects all aspects of clinical trial management and allow administration to focus on making strategic decisions based on analytics and accurate real-time data.

References: Original article can be seen at Applied Clinical Trials with

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Anayansi Gamboa, MPM, an EDC Developer Consultant and clinical programmer for the Pharmaceutical and Biotech industry with more than 13 years of experience.

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