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CGI’s clinical and regulatory optimization practice focuses on improving the operations of your clinical and regulatory teams. We support the entire lifecycle of clinical development: from study planning through clinical study reporting, as well as across the various functions in R&D, from medical writing through monitoring and clinical data management, and regulatory information management.
eTMF
Effectively manage and transform your organizations TMF operations
Risk-Based Monitoring
Increase operational efficiency, reduce cost and regulatory submission risk
Inspection Readiness
Install and maintain a culture of compliance for improved inspection readiness
Regulatory Information Management
Drive digital maturity and stay on top of complex regulatory demands
Clinical Architecture
Comprehensively address industry gaps in your organizations clinical systems and processes
CTMS
Implement the right system to help streamline operations at your clinical research sites.