Clinical trials pharma
Statistics and biometrics in clinical studies (pharmaceutical industry)
Call us on Tel .: 49 (0) 341 3910195 or contact us by email: info@acomed-statistik.de.
ACOMED statistics offers all statistical or biometric services that you need to conduct clinical studies. For the pharmaceutical industry, we primarily accompanied phase IIb / III / IV studies and observational studies. There is also experience with special designs such as cluster randomized studies and bioequivalence studies. ACOMED acts as a direct contractor, as a subcontractor for CRO or, in the case of DSMB, as an additional statistical service provider. You will find references here.
We offer the following services:
Statistical advice on biometric aspects of the study protocol
- Support your commitments from Study goals and endpoints
- Definition of a corresponding study design
- Ensuring biometric aspects of internal and external validity as well as sensitivity
- Supporting your determinations of the study population as well as inclusion and exclusion criteria
- estimate Sample size (number of cases). Available software: PASS, NQuery-Advisor, SAS Power
- Creation of the statistical chapter of the study protocol: hypotheses, definition of the planned analyzes, definition of the primary and secondary variables, specification of interim analyzes, definition of the evaluation populations (intented to treat ITT, per protocol PP)
- Definition of the randomization process
- Proposing solutions to critical issues within the clinical trial
Support for the study process
- Support in the application process (e.g. ethics committee)
- Review of external documents (entry forms, data management plan, data validation plan)
- Participation in the DSMB (data safety and monitoring board)
SAS programming
see services SAS programming
Preparation and implementation of the data review meeting
- Creation of lists and tables to characterize incorrect and missing values
- Creation of lists and tables for protocol deviations
- Definition of the analysis populations
Statistical analysis plan (SAP)
- Exact description of the study evaluations (demography and baseline characteristics, efficacy, safety)
- Extended information on biometric aspects of the design
- Exact description of the study variables (categories)
- Description of variables to be calculated
- Variable-based definition of methods for addressing missing values
- Precise representation of the statistical methodology
- Analysis of covariates, prospective determination of subgroup analyzes, adequate addressing of missing values,
- Sensitivity analysis (Estimands)
- Specification for the SAS programmer
- Extended information to determine 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 TLF (filled with placeholders) (mocks, table shells)
Statistical analysis
- Descriptive statistics
- Analysis of primary and further study goals
- if necessary, use of complex processes (GLMM etc.)
- Addressing missing values, sensitivity analyzes (according to the Estimands concept)
- SAS® programming
- Other available software: R, SPSS® 20.0, NCSS, PASS, nQuery-Advisor.
Support with the creation of the reports
- Creation of the statistical report
- Creation of statistical chapters for clinical reports and publications
- Support in the creation of further chapters (medical writing)
All of these services are carried out in accordance with the internal SOP as well as GCP and the applicable guidelines (ICH).
