Clinical trials: Statistics and biometrics
Partners for the pharmaceutical industry
ACOMED statistik works as a statistical service provider for clients in the pharmaceutical industry, supporting Phase IIb/III/IV studies and bioequivalence studies. We also participate in Data Safety and Monitoring Boards (DSMBs) and perform validation tasks.
The customers are large and medium-sized companies, primarily from Germany, Switzerland and the USA (References)
Partners for the medical device industry
Due to EU regulations 2017/745 (the Medical Device Regulation, or MDR) and 2017/746 (the In Vitro Diagnostic Regulation, or IVDR), clinical studies in the field of medical devices are becoming increasingly important and must be planned and evaluated to a higher quality standard. ACOMED Statistik has many years of experience and excellent references, and is happy to be your partner.
Partners for the diagnostics industry
Diagnostic studies are one of the main focuses of ACOMED statistik.
Partners for CRO
For more than 15 years, ACOMED statistik has been working with CROs from Germany and the USA as their subcontractor.
If your CRO therefore has a capacity bottleneck in the biometrics department and/or in the SAS® programming, please feel free to contact us.
ACOMED statistics: Statistical service provider for clinical trials
Study concept and study planning
During the study design phase, the endpoints, study population, and basic design are defined. ACOMED statistik contributes biometric aspects, such as interim analyses, and makes initial considerations regarding sample size. The final step is the protocol synopsis.
ACOMED statistik then assists in the creation of the study protocol, particularly the statistics chapter. The determination of the sample size (number of cases) is finalized.
One of ACOMED statistik's strengths is its extensive knowledge of and experience with measurement methods (e.g., laboratory) and instruments (e.g., questionnaires), as ACOMED statistik has also provided statistical support for validation studies. Are the endpoints being measured with sufficient accuracy, precision, and sensitivity?
The creation of the statistical analysis plan (SAP) usually takes place during patient recruitment. All statistical parameters are defined in the SAP, and the table shells fully specified. ACOMED statistik offers SAS programming for complete dummy table shells.
Furthermore, ACOMED statistik takes over the verification of documents, e.g. the data collection forms or input masks for eCRF.
Study implementation
ACOMED statistik is generally not directly involved in conducting studies. Either ACOMED statistik collaborates with the CRO commissioned by the sponsor, or ACOMED statistik acts as a subcontractor for contract research organizations (see References).
Once the data collection is complete, ACOMED statistik provides the tables and listings for the data review meeting, in which the data quality is finally checked and, in particular, protocol violations are assessed.
Study evaluation
Special statistical or biometric tasks
- In the case of adaptive designs, ACOMED statistik performs independent interim evaluations for other statistical service providers and assesses the results.
- ACOMED statistik performs validation tasks for other statistical service providers or CROs.
- Dr. Thomas Keller has experience working as a statistician on the DSMB (Data Safety and Monitoring Board). We would be happy to assist you in this regard.
