Biostatistics

Ensure proper collection, verification, and delivery of Clinical Trial data through collaborative partnerships. inSeption partners with other organizations who share in our commitment to quality and exhibit proven expertise and the ability to provide high quality deliverables on time and within budget.

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