Services Overview:

The services requested are for Statistical Programming for clinical trials Phase I – IV utilizing SAS (Base and Macros) and R.

Deliverables:

+ Services rendered will adhere to applicable client SOPs, WIs, policies, local regulatory requirements, ICH-GCP, etc.
+ Creation of ADaM datasets based on current ADaM standards.
+ Creation of Tables, Listings and Figures following client specifications
+ Creation of Subject Narratives following client templates to support Narrative development.
+ Creation of other ancillary data streams including (but not limited to) clinical registry reporting files (e.g. Clintrials.gov, EudraCT), Bioresearch monitoring reports (BIMO).
+ QC of all programmed output
+ Creation and/or maintenance of detailed specification documentation
+ Development and validation of electronic submission packages that comply with submission requirements from FDA, EMEA and other regulatory agencies as needed.
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