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.
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
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.
Authoring & assembly
Document assembly, Component authoring
Word as the editor, enhanced with advanced authoring and tagging through add-ins
Collaboration portal, secure role based access
Integrated with systems of record ( clinical trial management systems, SAP, etc)
Document hierarchies, associations
Ability to track changes to protocols, amendments, sections