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. ...