Why do you need to effectively manage your TMF? Trial Master File (TMF) is the common term for a sponsor’s regulatory-required essential documents for a clinical trial. A quality and complete ...

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.


Effectively manage and transform your organizations TMF operations

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Risk-Based Monitoring

Increase operational efficiency, reduce cost and regulatory submission risk

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US Health and Life Sciences Research and Development Inspection Readiness

Inspection Readiness

Install and maintain a culture of compliance for improved inspection readiness

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Regulatory Information Management

Drive digital maturity and stay on top of complex regulatory demands

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US Health and Life Sciences Research and Development Clinical Architecture

Clinical Architecture

Comprehensively address industry gaps in your organizations clinical systems and processes

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US Health and Life Sciences CTMS


Implement the right system to help streamline operations at your clinical research sites.

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