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idv - Data Analysis & Study Planning (founded in 1967)

The enterprise, idv - Data Analysis and Study Planning, was founded in 1967 by Dr. phil. Volker Rahlfs as the first independent German Clinical Research Organization focusing on Biometry / Psychometrics in the biomedical and pharmaceutical sciences.

Our main focus is on:

· Planning and evaluating clinical studies for Research Phases II-IV

· Seminars, organized and held since 1972 to refresh, expand, and deepen professional knowledge and thus the competence of employees involved in research for the pharmaceutical industry as well as employees of universities and non-university research organizations exploring the biosciences.

· Development of validated software packages for research (since the beginning of the PC era), development of biometry procedures, which among other things were recognized and established throughout the entire world as industry standard.

· Producing expert reports, replying to reprimands related to defects and representing biometrical issues in the court room as well as before regulatory authorities (e.g. FDA, BfArM).

· Promoting quality by design: audits of study protocols and Case Report Forms (CRF and e-CRF).

· Establishing a quality-assured system conforming to FDA 21 CFR Part 11: this system gathers, manages, and evaluates data (software systems and high-security computers). Validation of the systems, tutoring with certification.

· Implementing systems for improving quality of study data: definition and structuring the rating scales within central rater review services, quantifying quality using quality coefficients (ICC), establishing systems for risk based central monitoring (ISCCS®) as recommended by the FDA /USA, EMA).

· Special tasks in clinical research: planning of a series of projects as an ensemble, meta-analyses (formal summarization of several research projects). Subgroup analyses, re-analyses, and re-reports of clinical studies, which were previously not accepted.

An important part of our results is routinely used today in the fields of biometric methodology and software development: In 1985, idv was – worldwide – the first software developer to make permutation algorithms commercially available. Of the more 120 publications by members of idv, about 80 are exclusively methodologically oriented. Currently the primary focus of our research is the development of robust effect size measures, useful for benefit/risk assessment.