Studies

Reanalyses

About Guidelines and the Tools of the new Biometry now required by Regulatory Authorities:

Sample size, precision of the study

Test for equivalence

Test for non-inferiority

Measures of effect size

Confidence regions

Multiple tests

On request, we would be pleased to send you a list of the usual items on lists of defects in clinical studies, which we have compliled.

Re-Analyses

idv - the Specialist for professional Re-Analyses

The guidelines ICH-GCP E3 and ICH-biostatistics E9 set a compulsory new standard for the quality of clinical studies. Accordingly, the regulatory authorities classify many previously performed studies as so-called "old studies".
Appropriate re-analyses cannot transform meaningless or poorly supported studies into confirmatory studies (because of faulty preplanning). Such studies can, however, often provide good supportive study reports with valid information through our re-analyses.
Extract the maximum from the capital invested in your studies! Let the professionals at idv re-analyze study evaluations that are no longer current and/or any other questionable results.
Secure the maximum quality with reference to acceptance from BfArM and conformity with the relevant ICH-Guidelines E3 and E9.

Efficacy Re-Analysis

Re-analysis of the efficacy data and the compiling of the efficacy section of the clinical study in accordance with ICH

Reformulating of study objectives with operationalization
Definition of the evaluation populations and/or data sets
State-of-the-Art efficacy analysis
Compiling of reports with reference to efficacy in accordance with ICH-guidelines

Re-analysis of the safety data and compiling of the safety section of the clinical study in accordance with ICH

Only AE's in accordance with ICH-guidelines WHO ART and/or MedDRA
AE's (WHO ART and/or MedDRA) and laboratory value evaluation in accordance with ICH-Guidelines

Complete re-analysis of efficacy and safety and then compilation of a new report in accordance with ICH