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statistical design and analysis in medicine

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ACOMED statistics - service provider for statistical design and analysis of clinical trials

ACOMED statistics provides all statistical and biometrics-related services for your clinical trials.

Statistical aspects of study protocol

  • Supporting your definition of study objectives and endpoints
  • Appropriate design of the study, patient's pathway
  • Supporting your definition of inclusion and exclusion criteria
  • Estimation of sample size
  • Writing the statistical section of the protocol stating the hypothesis, defining the planned analyses, primary and secondary variables, time periods, interim analysis specifications, intented-to-treat-population, per-protocol-population
  • Randomization
  • Suggesting solutions on critical issues within clinical trials

Statistical analysis plan (SAP)

  • Estimation of sample size using NQuery Advisor® 2.0 (Statistical Solutions), PASS 2007 (NCSS), SAS 9.2 (PROC POWER) or internal tools
  • Details of randomisation schedule
  • Support in terms documentation, Design of CRF
  • Choice of appropriate statistical methods, statistical analysis, statistical software (SAS®)
  • Analysis of covariates

Support in performing clinical trials

  • Review of external documents (CRF, data management plan, data validation plan)

Statistical analyses

  • SAS® programming
  • Further software is available: SPSS® 15.0/20.0, NCSS, Medcalc®, Analyse-It®, EquivTestTM 6.0 and R.

Support in writing reports

  • Writing statistical report
  • Writing statistical chapters of clinical study report
  • Writing statistical and results chapters of publications, supporting other chapters

All these services are conducted according to an internal GCP compliant SOP-system.

 
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study protocol
protocol for clinical trial statistical analysis plan SAS program