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Regulatory Submissions Support

Cytel has prepared over 150 successful studies for NDA submissions to FDA, EMA, PMDA, HealthCanada and numerous other global regulatory bodies.
 
As a registered solutions provider of the Clinical Data Interchange Standards Consortium (CDISC), Cytel’s regulatory submissions teams are well-versed in the clinical data submission models that regulators are coming to expect in their clinical trial assessments.

As a registered solutions provider of the Clinical Data Interchange Standards Consortium (CDISC), Cytel’s regulatory submissions teams are well-versed in the clinical data submission models that regulators are coming to expect in their clinical trial assessments.

Strategy for Submissions

Whether a sponsor’s trial is a complex clinical study design or built on traditional statistical principles, and regardless of how data has been stored and managed across clinical trial sites Cytel will help to reveal the full promise of your product.

Whether working with a single sponsor, or managing various clinical operations and data management vendors for a sponsor, Cytel’s standardization experts will help sponsors build a strong case for their product.

Through rigorous training and years of industry experience, Cytel provides expert project management and strategic consultation for submissions using the Study Data Tabulation Model (SDTM) and the Analysis Data Model (ADaM). 

Our expert Statisticians will guide and implement rigorous data pooling and analysis strategies to optimize likelihood of success.

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Power

A team of experts ready to guide the strategy, design, execution, standardization and analysis of your data, and help demonstrate the to communicate the value of your therapy. Showcasing the power of your clinical trial. 

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Intelligence

Strong on-going evidence of success in regulatory affairs and clear proficiency in data standardization and submission models devised by the Clinical Data Interchange Standards Consortium (CDISC). 

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Confidence

A proven track-record of FDA and EMA acceptances, and other global regulatory body approvals for data conversion and submission. 

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