News
Adaptive Design according to Bauer-Koehne
The newest software developed by the firm idv: Adaptive studies shorten the development time and...
FDA 21 CFR Part 11 - Inspection
The inspector: "idv system with high security computer and software is light years ahead of other...
Graphics in TESTIMATE
Scientific presentation graphics are now in TESTIMATE according to the new FDA Guidance for...
Extended Meta Data and Audit Paper Trail in TESTIMATE
Possibilities for specifying metadata for simple applications and more comprehensive auditing...
New Statistical Procedures in TESTIMATE
Su-Wei test, Wei-Lachin procedure and Efron test in TESTIMATE. Also new exact binomial confidence...
Seminars
Quality seminars starting from scratch or refreshing what you already know - for everyone from beginners to professionals.
We organize schooling, seminars, and workshops on our customer's premises (on site) or, when requested, in our own seminar center in Gauting, Germany (near Munich).
Why Learn and Train Further at idv?
- idv has over 40 years of experience organizing continuing education for those interested in clinical research: 40 years of continuity and quality.
- idv has over 45 years of practical experience in the planning and evaluation of clinical studies: we have evaluated more than 800 national and international studies.
- idv has had its own research team continually for more than 45 years. The team is composed of mathematician, statisticians, and various professional scientists. Here new biometrical procedures are developed, discussed, implemented, and publications are prepared for professional journals.
- idv is present and future oriented: because of our methodological work we have often been able to implement requirements of various guidelines into our practical research and teaching years before their being published as official (de jure) standards.
- idv is almost always aware of the evolution of unwritten (de facto) standards through contact with officials and from attending current professional symposiums as well as from processing lists of defects within the framework of our consulting activities.
- All idv seminars are assessed for the DGPharMed (Deutsche Gesellschaft für Pharmazeutische Medizin e.V.) and serve as well for the further education that is prescribed by GCP (Good Clinical Practice).
The Concept
- Not an academic theory course, but rather practical training for non-statisticians by experienced biometricians based on current ICH biostatistical guidelines.
- First hand experience: Specialists for clinical research relate knowledge to the current requirements of ICH, FDA, EU, and BfArM.
- Understanding instead of collecting facts: The overriding objective of our seminars is impart an understanding of important relationships and the ability to implement this understanding in one's own practical work.
In the navigation menu on the left, choose a page with further information or click one of the following links.
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- Basis biometry of clinical trials: Introduction and refresher
- The clinical trial: Design und study report
- Blind review in accordance ICH guideline E9
- Rational compiling of the clinical study report in agreement with guidelines ICH E3 and E9
- Workshop CHMP guidelines
- User-Workshop: GCP conform evaluation in accordance with GCP and FDA 21 CFR Part 11, with idv programs
- Query form for anyone interested
