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 specificationsCreation 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 outputCreation and/or maintenance of detailed specification documentationDevelopment and validation of electronic submission packages that comply with submission requirements from FDA, EMEA and other regulatory agencie...