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Biostatistics

Statistical analysis is an essential part of any research, both at the study planning stage and during data analysis. We offer some services like sample size calculation or statistical analysis plan development along with full statistical analysis, including interpretation of results, creation of a draft report, and a final report.

Our services for data analysis:
  • Statistical analysis plan
  • Statistical analysis
  • Clinical study report

Our company has 10 years of experience in biostatistics. We use professional software for data analysis. Our consultants for mathematical methods in medicine and biostatistics are regular members of the American Statistical Association, so we are always up on the latest advances and have the opportunity to consult with expert leaders in biostatistics.

Statistical analysis plan

For plan development, we need the customer-approved clinical study protocol and case report form.

Development steps:
  • Review of the clinical study protocol and case report form
  • Statistical analysis plan development
  • Unlimited document discussion and its finalization, according to customer requirements
  • Regulatory and common quality control of the final document and the document structure review
  • Proofreading before the document is finalized
  • Initial, interim, and final teleconference during document development (as needed)
  • Unlimited storage period for the final document
Statistical analysis

For statistical analysis, we require the customer-approved statistical analysis plan. For data review, we use licensed software Stata 14 (StataCorp, USA). We work with any data format.

Development steps:
  • Statistical analysis plan assessment
  • Database converted to Stata format
  • Database check for input errors, inaccuracies, logical mistakes, etc. (queries to the customer are expected)
  • Missing values management, according to the statistical analysis plan (exception or mathematical amendment)
  • Table and graph template development
  • Data processing program written in Stata language
  • Output of results in tables or graphs with comments
  • Initial, interim, and final teleconference during data analysis (as needed)
  • Unlimited storage period for the final database, table and graph templates, program code, and final analysis data
Final study report

The report format must meet the actual regulatory requirements (FSBI SCEMP Drug expert review guidelines at the time of this text publication). If the customer or a third party-provided statistical analysis results are inconsistent with the statistical analysis plan and clinical study protocol, additional statistical analysis might be approved (see Statistical analysis). We also offer writing the review of the pharmacokinetics reports and bioanalytical methods validation reports.

For report preparation, we require certain documents approved by the customer:
  • Clinical study protocol
  • Statistical analysis plan
  • Statistical report with tables, graphs, and comments according to the statistical analysis plan
  • Drug information leaflet
  • Investigators brochure
  • Lab test limits
  • Criteria for the clinical significance of deviance (if not specified in the protocol)
  • Detailed leaflet of the protocol deviations
Development steps:
  • Review of the clinical study protocol
  • Report structure adjustment if its description is unclear in the protocol, statistical analysis plan, or other documents
  • Clinical study report development
  • Unlimited document discussion and finalization, according to customer requirements
  • Regulatory and common quality control of the final document and the document structure review
  • Proofreading before finalization of the document
  • Initial, interim, and final teleconference during document development (as needed)
  • Unlimited storage period for the final document