Transforming Document Management for Clinical Trials

Challenge:

Ensure global adoption (over 3,000 users) of an industry-leading cutting edge tool that spanned the lifecycle of pharmaceutical development and represented a significant shift in the way the organization operated.

Situation:

The client, a global Pharmaceutical company, was implementing a cloud-based platform consisting of multiple systems to facilitate the creation, management, collaboration, approval, and archiving of clinical trial documents, SOPs, and regulatory dossiers. ‚ÄčTheir intention was to have a single authoritative source for document management with globally harmonized processes.

 

This was the most aggressive system and process transformation the company had ever undertaken. It would enable them to leap from a document management architecture that lagged behind the competition to one that was at the top of the pack . . . if they could ensure widespread adoption.

Project Synopsis #1

What We Did:

  • Supported the implementation by creating a highly effective dynamic approach to OCM over the course of this 18-month project
     

  • Developed a robust communication strategy that leveraged all existing channels for communications and developed new ones to broaden our reach to internal and external stakeholders
     

  • Performed and analyzed organizational and stakeholder assessments
     

  • Delivered frequent and consistent communications to executives and stakeholders to instill awareness and implementation readiness, including a monthly newsletter
     

  • Prepared materials to support stakeholder engagement aimed at informing, educating, and motivating (e.g., presentations, pitches, speaking notes)
     

  • Helped establish and manage a robust Change Champions Program to drive engagement and adoption
     

  • Provided training coordination and communications to support a successful learning program
     

  • Oversaw the work of an agency charged with designing posters, infographics, handouts

Outcome:

  • Generated a palpable buzz that broadened awareness and support of the project, effectively conveying its vision, goals, and benefits through a narrative that created a desire for the future state
     

  • Successful stakeholder coordination and engagement in project activities.
     

  • Minimized post-launch user issues and helped to cement the new way of working
     

  • Achieved successful adoption rates within a month of launch; continuing to support the client with communications for system updates, message reinforcing; the system is firmly embedded as the way regulatory-related documents are managed
     

  • The project was recognized by leadership as the standard-bearer for a robust OCM program

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