Biostatistics

Changing the Paradigm

• Our approach to programming and TLF output is that it should be usable and interpretable as a data review tool during study conduct and as the foundation for any internal client need, complementary to its preparation as part of the final study analysis
• Our “one client at a time” philosophy allows us to operate as a “virtual” statistics and programming discipline within your organization
• Our dedicated programming and data management effort allows for ongoing, “real time” clinical review of trial data, without the limitation of batch-dependent “old” data downloads
• Our wealth of professional experience gives us special insight into regulatory hurdles requiring fast turnaround of re-analysis/re-submission of results
• Using the data from clinical trials, we provide a variety of expertise for quantitative support of medical advisory boards, product promotion, and other commercial needs.

The inSeption Group Can Help You

• Complete, comprehensive data analysis and generation of all required tables, listings, graphs and any other output required for ongoing and final clinical/statistical evaluation of results
• Execute all computer programming and output processing of “report-ready” output, including fully reproducible programs for use by regulatory reviewers
• Specify and prepare all data sets and output for US and international regulatory submissions
• Write all regulatory documents, reports, and internal presentations/communications
• Ensure statistical expertise and management of all data and programming activities on behalf of study execution, analysis of results, support for scientific presentations, and commercial needs
• “Rescue” projects where statistical/programming aspects are incomplete or weren’t performed properly to your satisfaction
• Restart a “dormant” project to investigate new deas or plan for new indications