Statistics & biometrics
Clinical trials: statistics and biometrics
Call us on Tel .: 49 (0) 341 3910195 or contact us by email: info@acomed-statistik.de.
ACOMED statistics has been offering services in the fields of statistics and biometrics as part of clinical research for customers in Germany, Europe (mainly Switzerland), as well as in the USA and India. The focus is on thedesign and analysis of clinical studies. ACOMED statistics has experience in the field of clinical studies in the pharmaceutical industry, the medical device industry and the diagnostics industry.
The implementation takes place according to an internal quality manual or internal SOP. The GCP or ICH regulations are fully complied with.
Partner for the pharmaceutical industry
ACOMED statistics works as a statistics service provider for customers from the pharmaceutical industry in the context of phase IIb / III / IV studies and bioequivalence studies. We are also active in Data Safety and Monitoring Boards (DSMB) and carry out validation tasks.
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The customers are large and medium-sized companies mainly from Germany and Switzerland (cf. references)
Partner for the medical device industry
Due to the EU regulations 2017/745 (Medical Device Regulation (MDR)) and 2017/746 (IvD), clinical studies in the field of medical devices are becoming more important and must be planned and evaluated qualitatively at a higher level. ACOMED statistics can look back on many years of experience and very good references refer and is happy to be available as your partner.
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Partner for the diagnostics industry
Diagnostic studies is one of the main focuses of ACOMED statistics.
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Partner for CRO
ACOMED statistics has been working with CRO from Germany and the USA as their subcontractor for more than 15 years.
So your CRO has a capacity bottleneck in the biometric department and / or in the SAS programming, please feel free to contact us.
ACOMED statistics: Statistics service provider for clinical studies
Study conception and study design
When designing the study, the endpoints, the study population and the basic design are defined. ACOMED statistics brings biometric aspects here, e.g. on interim analyzes, and makes initial considerations about the sample size. At the end is the synopsis of the protocol.
ACOMED statistics then contributes to the preparation of the study protocol, especially the statistics chapter. The determination of the sample size (number of cases) is finalized.
One of the strengths of ACOMED statistics is very good knowledge of and experience with measurement methods (e.g. laboratory) or measurement instruments (e.g. questionnaires), because ACOMED statistics has also supported statistical validation studies. Are the endpoints measured correctly, precisely and sensitively?
The statistical evaluation plan (SAP) is usually created during patient recruitment. All static issues are defined in SAP and the SAS programming is fully specified. Here ACOMED statistics offers the SAS programming of the (empty, i.e. filled with placeholders) table shells.
In addition, ACOMED statistics takes over inspection tasks of the documents, e.g. the registration forms or input masks for eCRF.
Study conduct
As a rule, ACOMED statistics is not involved in the direct conduct of the study. Either ACOMED statistics works with the CRO commissioned by the sponsor or ACOMED statistics is a subcontractor of contract research institutes (see references) active.
Once the data collection has been completed, ACOMED statistics provides the tables and listings for the data review meeting, in which the data quality is checked and, in particular, the protocol violations are assessed.
Study evaluation
SAS programming (if not part of the SAP creation), data transfer including validation, analysis including validation (depending on the assignment: consistency checks of the results, code review, double programming), statistical report, collaboration on the clinical report.
Special statistical or biometric tasks
- In the case of adaptive designs for other statistical service providers, ACOMED statistics carries out independent interim evaluations and evaluates the results.
- ACOMED statistics carries out validation tasks for other statistical service providers or CRO.
- Dr. Thomas Keller has experience working as a statistician in DSMB (data monitoring committee, data safety and monitoring board). We would be happy to support you in this regard.
