Clinical Process Roadmap

SITUATION

A global medical device company with clinical operations staff in multiple locations that had grown through acquisitions wanted to harmonize their SOPs into a single repository. They wanted a mechanism to organize the procedures into a useful job aid which would be used globally.

SOLUTION

  • Halloran developed SOPs for several key processes.
  • Harmonized disparate SOPs into a single, streamlined global set.
  • Halloran mapped the SOPs into a roadmap of the clinical trial process associating key clinical trial activities with global procedures.
  • Halloran created an integrated training matrix aligning activities and procedures by function and role along with a responsibility matrix to promote accountability and transparency within the clinical trial process.

VALUE

The Company now has a single, simplified quality system to support all international locations. Their Roadmap serves as a tool for onboarding and provides on-going training for a growing organization. The solution is also scalable and easily configurable to address ongoing SOP implementation as well as training and development activities. The Roadmap may serve as a blueprint for learning management system (LMS) architecture and can also be readily configured to serve as a dynamic end-user training and development tool.