Statistical & Database Programming

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We utilize state-of-the-art technology and metadata-driven tools for clinical and statistical programming to achieve high quality, consistency, efficiency, and cost-effectiveness. Our programmers supply datasets fully compliant with industry standards for all regulatory requirements.

The Pharmapace team of analysts have various levels of clinical experience and diverse expertise in many therapeutic areas and various indications, such as metabolic diseases (diabetes, obesity and NASH), oncology, neurosciences, insomnia, cardiovascular diseases, ophthalmics, and agitation. Each staff member has advanced degrees in scientific majors. They are all highly motivated and dedicated.

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