pharmtrace experts have extensive experience in the strategic management and direction of major clinical development programmes as well as in the use of imaging and biomarkers in clinical strategies. pharmtrace is closely linked to the Berlin-based "Competence Network Lifescience" (CONELIS) and provides comprehensive support to select, implement, manage and report solutions for all developmental phases from a regulatory, market and operational perspective.

Due diligence / medical need assessment. Determination of novelty and real world clinical utility. Qualitative and quantitative assessment of therapeutic effectiveness and market potential in target indications coupled with identification of key strategic market positioning arguments.

Optimisation of clinical development plan. Comprehensive support, based on a unique combination of expertise in imaging, diagnostics and drug development, to optimally incorporate medical imaging and biomarkers into drug development and life-cycle management programmes.

Regulatory. Support constructing regulatory strategy for development programmes and in drafting summary evidence, including the collation and review of clinical data, to support regulatory submissions and responding to regulatory queries.

Life-cycle management & scientific publication support. Encouragement, management and coordination of investigator-initiated studies including the compilation and evaluation of clinical data and the drafting and organization of scientific papers for publication.