Statistics and biometrics in clinical trials (medical devices)

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

Contact ACOMED statistics (Tel.: 0341/3910195, E-mail: info@acomed-statistik), if you require support in planning and analyzing a clinical study for your medical device in accordance with EU Medical Device Regulation 2017/745.
ACOMED Statistics offers all the statistical and biometric services you need to conduct clinical trials. ACOMED Statistics has extensive and long-standing experience in clinical trials for the medical device industry. The requirements for high-quality and statistically sound planning and analysis of such studies, as mandated by EU Regulation 2017/745 (Medical Device Regulation (MDR)), have increased significantly. ACOMED acts as both a direct contractor and a subcontractor for clinical research organizations (CROs). References can be found [here/on our website]. here.
Medical device manufacturers are often accustomed to conducting studies with small sample sizes. Statistical analysis was typically handled using "homegrown" methods. 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 leverage its experience in pharmaceutical studies.
We offer the following statistical services:

Statistical advice regarding biometric aspects of the study protocol

  • Conception of the study design
  • Support in defining study objectives and endpoints
  • Ensuring biometric aspects of the internal and external validity as well as the sensitivity of the study
  • Support in defining inclusion and exclusion criteria (study population)
  • Determining the sample size (number of cases)
  • Possibly planning interim analyses
  • Preparation of the statistics chapter of the study protocol (hypotheses, definition of primary and secondary variables, statistical methodology of the analyses, interim analyses, definition of the evaluation populations)
  • If necessary: Determination of the randomization procedure
  • Proposed solutions in case of critical aspects within the clinical trial

Support in conducting the study

  • Randomization
  • We do not offer the following services directly, but we can support you, for example, by reviewing documents: data management, review of external documents (data collection forms, data management plan, data validation plan)

Creation of the Statistical Analysis Plan (SAP)

Details can be found on the information page about pharmaceutical studies:SAP

SAS programming

Preparation and execution of the data review meeting

  • Creation of lists and tables to characterize erroneous and missing values
  • Creation of lists and tables regarding protocol deviations
  • Definition of the analysis populations

Statistical analyses

  • Descriptive statistics
  • Analysis of primary and secondary study objectives
  • Addressing missing values
  • Subgroup analyses

Support in creating reports

  • Statistical Report
  • Chapters on Materials and Methods and Results within the Clinical Study Report (CSR)
  • Publications
These services are performed in accordance with internal SOPs as well as GCP and applicable guidelines.