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You are at: statistical design and analysis
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® 15.0/18.0, 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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