Statistics and biometrics in clinical trials (pharmaceutical industry)

Call us on Tel.: 49 (0) 341 3910195 or contact us by email: info@acomed-statistik.de.

ACOMED Statistics offers all the statistical and biometric services you need to conduct clinical trials. For the pharmaceutical industry, we have primarily supported Phase IIb/III/IV trials as well as observational studies. We also have experience with specialized designs such as cluster-randomized trials and bioequivalence studies. ACOMED acts as a direct contractor, as a subcontractor for CROs, or, in the case of DSMBs, as an additional statistical service provider. References can be found [here/on the website]. here.

We offer the following statistical services:

Statistical advice regarding biometric aspects of the study protocol

  • Supporting your decisions regarding Study objectives and endpoints
  • Concept of Estimands
  • Establishing an appropriate study design
  • Ensuring biometric aspects of internal and external validity as well as sensitivity
  • Support for your determination of the study population as well as inclusion and exclusion criteria
  • estimate Sample size (number of cases)Available software: PASS, NQuery Advisor, SAS Power
  • Preparation of the statistics section of the study protocol: hypotheses, definition of planned analyses, determination of primary and secondary variables, specification of interim analyses, determination of the evaluation populations (Intented to treat ITT, per protocol PP)
  • Determination of the randomization procedure
  • Proposal of solutions in case of critical aspects within the clinical trial

Support in conducting the study

  • Support in the application process (e.g., ethics committee)
  • Review of external documents (data collection forms, data management plan, data validation plan)
  • Participation in the DSMB (data safety and monitoring board)

SAS programming

See services SAS® programming

Preparation and execution of the data review meeting

  • Creation of lists and tables to characterize erroneous and missing values
  • Creation of lists and tables regarding protocol deviations
  • Definition of the analysis populations

Statistical Analysis Plan (SAP)

  • Detailed description of the study evaluations (demographics and baseline characteristics, efficacy, safety)
  • Extended information on biometric aspects of the design
  • Full description of the study variables (categories)
  • Description of variables to be calculated
  • Detailed description of the statistical methodology
  • Analysis of covariates, prospective definition of subgroup analyses, adequate addressing of missing values
  • Variable-wise definition of methods for addressing missing values
  • Analysis of Estimands, sensitivity analyses
  • Specification for the SAS programmer
  • Extended information for determining the Sample size
  • List of all tables, lists and figures (TLF)
  • Specification of the form of the TLF (Mocks, Table Shells)
  • SAS® programming the complete (placeholder-filled) TLF (Mocks, Table Shells)

Statistical analyses

  • Descriptive statistics
  • Analysis of primary and secondary study objectives
  • Possibly using complex procedures (GLMM etc.)
  • Addressing missing values, sensitivity analyses (corresponding to the Estimands concept)
  • SAS® Programming
  • Other available software: R, NCSS, PASS, nQuery Advisor.

Support in creating reports

  • Preparation of the statistical report
  • Preparation of statistical chapters for clinical reports and publications
  • Support in creating further chapters (medical writing)
All these services are performed in accordance with internal SOPs as well as GCP and applicable guidelines (ICH).