Clinical trials medical devices

Statistics and biometrics in clinical studies (medical devices)

Biometric advice under the new requirements of EU Regulation 2017/745 / Medical Device Regulation (MDR)

Contact ACOMED statistics (Tel .: 0341/3910195, email: info @ acomed statistics), if you need support with the planning and implementation of a clinical study for your medical device according to the EU Medical Device Regulation 2017/745.
ACOMED statistics offers all statistical or biometric services that you need to conduct clinical studies. ACOMED statistics has extensive and long-term experience for clinical studies in the medical device industry. The requirements for high-quality and statistically adequate planning and analysis of such studies, as required by EU Regulation 2017/745 (Medical Device Regulation (MDR)), have increased significantly. ACOMED works both as a direct contractor and as a subcontractor for CRO. You will find references here.
Medical device manufacturers are often used to carrying out studies with small numbers of cases. The statistics were done with "home remedies". This is usually no longer compatible with the requirements of EU Regulation 2017/745. ACOMED statistics supports you in planning and evaluating your clinical studies under these new requirements of the Medical Device Regulation (MDR). ACOMED statistics can also bring in experience in the field of pharmaceutical studies.
We offer the following statistical services:

Statistical advice on biometric aspects of the study protocol

  • Conception of the study design
  • Support in setting study goals and endpoints
  • Ensuring biometric aspects of the internal and external validity as well as the sensitivity of the study
  • Support in determining the inclusion and exclusion criteria (study population)
  • Determination of the sample size (number of cases)
  • if necessary, planning interim analyzes
  • Creation of the statistical chapter of the study protocol (hypotheses, definition of the primary and secondary variables, statistical methodology of the analyzes, interim analyzes, definition of the evaluation populations
  • if necessary: establishment of the randomization procedure
  • Proposing solutions to critical issues within the clinical trial

Support for the study process

  • Randomization
  • We do not offer the following services directly, but support you e.g. by reviewing the documents: data management, review of external documents (data entry forms, data management plan, data validation plan)

Creation of the statistical analysis plan (SAP)

For details, see the pharmaceutical studies information page: SAP

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

  • Descriptive statistics,
  • Analysis of primary and further study goals
  • Addressing missing values,
  • Subgroup analyzes

Support with the creation of the reports

  • Statistical report
  • Chapter materials and methods as well as results chapter within the clinical study report (CSR)
  • Publications
These services are carried out in accordance with internal SOP as well as GCP and the applicable guidelines.
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