News

10/01/12 10:00

Extended Meta Data and Audit Paper Trail in TESTIMATE

Possibilities for specifying metadata for simple applications and more comprehensive auditing...

04/02/13 10:00

New Statistical Procedures in TESTIMATE

Su-Wei test, Wei-Lachin procedure and Efron test in TESTIMATE. Also new exact binomial confidence...

07/18/12 11:36

Graphics in TESTIMATE

Scientific presentation graphics are now in TESTIMATE according to the new FDA Guidance for...

06/11/12 17:55

Gold Standard Design of Study Planning

Gold Standard Design of Study Planning: New Substance, Reference and Placebo. The new definition of...

09/05/12 09:01

FDA 21 CFR Part 11 - Inspection

The inspector: "idv system with high security computer and software is light years ahead of other...

About idv

The firm, idv-Data Analysis and Study Planning, was founded in 1967 by Dr. phil. Volker Rahlfs as the first German contract research organization (CRO) providing specialized services for Biometry and Psychometry in the biomedical and pharmaceutical sciences.

Main Activities

  • Planning, performance, and evaluation of clinical studies for research-phases II-IV.
  • Organizing seminars (since 1972) for training staff members in the research departments of the pharmaceutical industry, universities and other institutions.
  • Developing new algorithms and validated software for the biometrical and psychometrical research.
  • Preparing expert reports and representing clients in court and before regulatory authorities (FDA, BfArM, etc.).
  • Performing quality assurance measures: Audits, tutoring, and certification.
  • Establishing a quality-assured, FDA CFR 21 Part 11 conform system for a validated working environment (high security hardware and software with tutoring).
  • Special tasks in clinical research: Meta-analysis, subgroup analysis, re-analyses, and re-reports of previously unaccepted clinical studies.

Research

For decades idv has invested consistently in the research and development of biometrical procedures and their software implementation: In 1985 idv became the first software developer to make exact permutational algorithms commercially available.

Publications

More than 100 publications from idv have appeared in professional journals. Many of these are method-oriented. Milestones are those publications dealing with the following topics: multivariate-multifactorial procedures, analysis of univariate and multivariate serial observations, analysis of contingency tables, measurement errors, cross-over analysis, non-parametric methods of analysis (asymptotic and exact permutational methods), equivalence (bio-equivalence and non-inferiority), sample size and power computations for all standard situations, multivariate and non-parametric tests, interim analyses with alpha-adjusting, effect size measures and confidence intervals, dose-effect relations, meta-analyses and subgroup representations.