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CDISC and statistical analysis for Phase I Study

The Agilis team is happy to have successfully completed another demanding biostatistics project for a Phase I study of an innovative inflammatory eye disorder treatment for a specialised CRO and an innovative biotech company. Our work at this last stage of the project was to prepare and validate the CDISC SDTM and ADAM packages for regulatory submission to FDA, and perform a full scale safety and tolerability statistical analysis, including pharmacokinetics.

The preparation of the CDISC SDTM clinical datasets and documentation was done using our own innovative software which automates the data complex transformation process from the clinical database, which in this case had been based on our own clinical data management cloud service. The SDTM generator software developed by our software engineers automates the data transformation eliminating the need for programming and allowing very short times for the production and validation of the datasets at a considerable lower cost than using typical programming.

The statistical analysis, generation and validation of hundreds of tables, listings and publication quality figures (TFLs), and production of a high quality statistical clinical study report according to ICH E3 requirements was done by our team of expert biostatisticians and statistical programmers, using the R statistical programming language and our own set of validated libraries and tools. The use of R gives us flexibility and ensures statistical quality at a lower cost for our customer.

Agilis is an innovative company dedicated to providing innovative technology and statistics services to clinical studies internationally, while working under the strict regulatory compliance requirements of pharmaceutical research. We know the value and impact of pharmaceutical research and are proud of the success of the research projects we have the opportunity to contribute to.

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