Data-Management, Pre-clinical and clinical biostatistics

AdWare Research Ltd. has been continously developing rigorous and detailed procedures for collecting, handling, validating, and reporting preclinical or clinical data.

AdWare Research provides data management and biostatistics services according to its SOPs, regulatory requirements, and international guidelines (FDA 21CFR Part11 and ICH E3, E6, E9, etc.). The informatical basis of our service is the Mythos CDMS that makes regulation-compatible data collecting and cleaning possible. SAS programme is used for data processing and for doing statistical analysis.

The main activity of data management and biostatistics (details):

  • Sample size determination
  • Writing the data management & statistical part of the study protocol
  • Randomization procedures & generation of randomization envelops
  • Designing and preparing the CRFs
  • Preparing and validating the data entry system corresponding to the study protocol (Using ORACLE® database)
  • Writing the Statistical Analysis Plan (SAP)
  • Writing the Data Cleaning Plan
  • Single or double data entry
  • MedDRA coding under medical control
  • Handling the Data Clarification Forms (DCF) or Data Query Forms (DQF)
  • Database closing
  • Statistical analyses according to SAP using SAS® software
  • Preparing the tabulated forms
  • Writing the statistical report according to ICH E3 (Structure and Content of Clinical Study Reports)
  • QA of the above activity according to ICH E6 (Guideline for Good Clinical Practice)

Adaptive Design Clinical Trials

Clinical trials can be designed with adaptive features (i.e., changes in design or analyses guided by examination of the accumulated data at an interim point in the trial) that may make the studies more efficient (e.g., shorter duration, fewer patients), more likely to demonstrate an effect of the drug if one exists, or more informative (e.g., by providing broader dose-response information). We have experience in the adaptive design of the study protocol, analysis of collected data, and our Mythos EDC system fulfils the data collection and handling requirements of the adaptive design.