Research and Development Optimization in the U.S. | CGI United States

Electronic Trial Master File (TMF) Factsheet

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 TMF is cornerstone to demonstrate clinical trial execution, and the key success factor for health ...

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Empowering transformation for clinical and regulatory teams

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.

Transformative R&D Solutions

US Health and Life Sciences Research and Development eTMF

eTMF

Effectively manage and transform your organizations TMF operations

US Health and Life Sciences Research and Development Risk-Based Monitoring

Risk-Based Monitoring

Increase operational efficiency, reduce cost and regulatory submission risk

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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US Health and Life Sciences Research and Development Regulatory Information Management

Regulatory Information Management

Drive digital maturity and stay on top of complex regulatory demands

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

CTMS

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

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