Statistical & Database Programming

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Expert Clinical Programming Across Therapeutic Areas

Key Areas of Programming Provided:

• Data strategy for regulatory submissions
• Analyses for the FDA advisory committee meetingsIntegrated summaries of safety and efficacy for regulatory submissions
• Global integrated database
• Tables, figures, and listings of clinical studies
• Database edit checks
• SDTM data mapping and ADaM creation along with define.xml and reviewers guide document
• CDISC compliance and validation
• Data mining
• Clinicaltrials.gov publishing
• Graphic patient profile
• Patient narratives
• Ad-hoc data analyses and reporting
• Annual safety reports
• Study quality surveillance programming for risk-based study monitoring