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327 E. Ridgeville Blvd, #122
Mount Airy, MD 21771-3900

240.744.0000

866.935.STAT (7828)

866.276.STAT (7828)

info@empiristat.com

www.empiristat.com

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Services - Statistical Analysis and Programming

Statistical Analysis and Programming

EmpiriStat provides a wide range of services throughout every project and clinical trial phase. Some services— such as statistical programming of table, listing and figure shells—provide a cost savings if programmed and validated while the trial is ongoing (instead of during the database closure and analysis phase). The range of our services can be categorized loosely by project/trial phase as follows:

Planning and Preparation Prior to Clinical Trial Initiation:

  • Provide statistical and study design expertise
  • Protocol development and writing including statistical sections and sample size and power calculations
  • Protocol scientific and statistical review
  • Randomization plan development, writing and implementation
  • Maintenance of blinding and unblinding plan documentation and review
  • Statistical analysis plans with table, listing and figure shells
  • Investigator Brochure summary of data, presentation, writing and review
  • Data and Safety Monitoring Board (DSMB) statistical report shells

Implementation Phase:

  • Statistical programming specifications writing and review
  • Statistical programming in SAS®
  • Statistical programming validation
  • Interim data monitoring and analysis

Database Closure and Analysis Phase:

  • Database review and cleaning
  • Clinical review programming
  • Primary statistical analysis and secondary review of statistical analyses and interpretation
  • Statistical reports and interpretation of results
  • Create presentations of statistical results for study reports, oral presentations, and publications
  • Present and publish study results as applicable

Post Clinical Trial Phase:

  • Abstract and publication analysis and preparation
  • Integrated Summary of Efficacy (ISE) plans and analyses
  • Secondary review of ISE plans and analyses
  • Integrated Summary of Safety (ISS) plans and analyses
  • Secondary review of ISS plans and analyses
  • Final clinical study report analyses, writing and review
  • Pharmocovigilance programming and assistance

Ongoing:

  • Statistical review and commenting for regulated documents, packets, filings and submissions
  • Statistical representation at regulatory meetings, including the FDA
  • Macro validation
  • IND annual report analyses, writing and review
  • Attend FDA meetings and conference calls with client, formulate questions and provide assistance with written responses
  • Assist with FDA meeting packets, IND, NDA and BLA filings

General:

  • Statistical standard operating procedures, work instructions, and templates
  • Unblinded statistician services for data and safety monitoring boards, prepare analyses, reports and present at DSMB, minutes recording during closed sessions

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