During the clinical research phase it is imperative for pharmaceutical companies to have strict compliance to good clinical practices and maintain full visibility and control over the conduct of a trial. This means managing and keeping each e-trial master file updated and current at all times. Further down the value chain, the organizations still needs to keep all regulatory information about the product updated and current. Due to the global nature of operations and commercialization, each trial has become a truly large team effort that includes internal and external collaborators. Each commercialization effort requires customization to local regulatory requirements, making the task of keeping information current increasingly difficult.

Customer challenges

Most solutions deployed to meet these requirements at pharmaceutical companies deliver standard documentation management capabilities with some amount of workflow/approval features. Key challenges remain around handling of:

  • multi-stakeholder input for authoring
  • version control at an object level
  • changes and amendments
  • document hierarchies and associations
  • handling complex document & object assemblies
  • advanced collaboration with external partners
  • meeting the compliance requirements of GxP, CSV, CFR Part 11.
  • Integration with clinical trial & safety systems

Solution overview

The CloudMoyo solution enables pharmaceutical companies to maintain full visibility and control over clinical trials and product documentation before, during and after conduction of a clinical trial, and well into marketing and life cycle management.

  1. Authoring & assembly
  • Document assembly, Component authoring
  • Word as the editor, enhanced with advanced authoring and tagging through add-ins
  1. Collaboration
  • Multi-stakeholder input
  • Collaboration portal, secure role based access
  1. Integration
  • Integrated with systems of record ( clinical trial management systems, SAP, etc)
  1. Document hierarchies, associations
  1. Versioning
  • Ability to track changes to protocols, amendments, sections
  1. Cloud based, compliant to GxP, CSV, HIPAA