Clinical trials: Statistics and biometrics

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

ACOMED statistik has been providing statistical and biometric services for clinical research since 2003 to clients in Germany, Europe (primarily Switzerland), the USA, and India. The focus is on the planning and analysis of clinical trials. ACOMED statistik has experience with clinical trials in the pharmaceutical, medical device, and diagnostics industries.

The procedure is carried out in accordance with an internal quality manual or internal SOP. The regulations according to GCP and ICH are fully complied with.

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 (see below). References)

Partners for the medical device industry

Due to EU regulations 2017/745 (Medical Device Regulation (MDR)) and 2017/746 (IVD), clinical studies in the field of medical devices are gaining in importance and must be planned and evaluated to a higher standard of quality. ACOMED statistik can draw on many years of experience and very good References refer you and is happy to be your partner.

Partners for the diagnostics industry

Diagnostic studies are one of the main focuses of ACOMED statistics.

Partners for CRO

For more than 15 years, ACOMED statistik has been working with CROs from Germany and the USA as their subcontractor.

Does your CRO therefore have a capacity bottleneck in the biometrics department and/or in the SAS® programming, so 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 SAS programming is fully specified. ACOMED-statistik offers SAS programming for the (empty, i.e., placeholder-filled) 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) employed.

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

SAS programming (if not done as part of SAP development), data transfer including validation, analysis including validation (depending on the scope of work: consistency checks of results, code review, duplicate programming), statistical report, collaboration on the clinical report.

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.