Research and Development Optimization

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.