Managing Integration of Clinical, Safety and Regulatory data as well as regulated documents
Subject Matter Expertise to ensure business continuity during the transition and migration process
Programme Management and reporting integrated with broader M&A operations
Integration of project plans and program management across the program of integrations
Programme Management Service with experienced Drug Development professionals. Using Chaucer’s best practices and tools where appropriate
To provide support and experience across the drug continuum including; trial registry CTMS, archiving, document management and archiving, clinical systems, safety systems, regulatory/labelling, content management and data and process integration.
Balanced on shore off shore resourcing model to provide optimal cost.
Concurrent integrations at any one time
Countries in scope of integrations
Integrated onshore off shore program team
Annual reduction of operating cost
How we delivered these results:
The Chaucer teams quickly integrate with clients to ensure successful delivery. Chaucer provided SMEs in the key domain areas of Clinical Data, Regulatory, Safety and Regulated Document Management. Our Project Managers utilized our PMOFlex™ approach to ensure a right sized and cost effective solution. Delivered with rigor to ensure the integration of assets was carried out in a practical, fit for purpose and timely manner
With process rigor, e.g. GCP, and attention to quality to enable reproducible and monitored migration process with data that was ready for use in time for all key milestones reporting and regulatory commitments.
If you think we can help you to implement your project or programme strategy, please call us on: +44 (0) 203 141 8400 in UK/Europe, or +1 713 821 1783 in the USA.