Market Access / Drug Development
Optimize product value and patient access.
Your Challenge
The key challenge of the benefit assessment of pharmaceuticals, both for innovation and for existing market products, is to produce a high quality and compelling user dossier which can face the high hurdles made by the requirements of the GBA and the methodology of the IQWiG
Our Solution
Creative Clinical Research (CCR) GmbH already has in-depth experience in strategy and the creation of benefit dossiers and other Health Technology Assessment (HTA) Value Dossiers. We are familiar with the specific challenges and have developed creative strategies to generate user dossiers efficiently and with high quality.
In the CCR benefit dossier, the sponsor has the advantage that the delegated parts of the dossier come "from a single source", allowing fast and straightforward communication with the sponsor's internal departments, a consistent style of the benefit dossier, and quick and flexible response to additional requirements.
CCR Solutions
✓ Support for the planning and coordination of the clinical development program and the requirements of a (future) benefit dossier
✓ Cross-studydata mining based on dossier data to identify additional benefit aspects, including multivariate analyzes
✓ Carrying out the additional subgroup analyzes (with descriptive and confirmatory statistics)
✓ Data extraction from statistical analyzes according to defined dossier formats
✓ Preparation
of medical and epidemiological modules of a user dossier
✓ Assistance in preparation and conduct of GBA counseling sessions
✓ Professional quality control and project management
✓ Thorough Literature
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