Dr. Martin Burschka

Clinical development scientist with many hats.

I am open for projects in Medical Affairs, and Regulatory Medical Writing incl. Data Analysis for due diligence and literature surveys., pharma as well as medical devices.

Evaluate new technologies in aesthetic medicine as candidates for startup financing or acqusition from a medical perspective.

Freelance clinical expert for various CROs,:eg: Johner Institute for QM in the health sector (Konstanz) CRI-Clinical Research International Ltd. (Cologne) • Write clinical evaluation reports. • SOP makeover and revision.

Regulatory advice on strategies for clinical drug dev. in all phases Clinical advice, author and support IB, IMPD, IND, Briefing document for Scientific Advice, Clinical parts of MAA, SPC, and post-marketing commitments, line extensions, variations and renewals Participate in client project teams Presentations Manage and mentor Medical Writers Therapeutic area advice Client and opinion leader relationships Peer review clinical documentation Training of staff

Assistenzarzt im Stationsdienst

Data management for the Population- Pharmakokinetics group at sanofi / Frankfurt a. M. --- Medical plausibility checks, compilation, documentation and validation of NONMEM-datasets. --- Automatized Reporting. --- Development of a NONMEM-based prediction-corrected posthoc Visual Predictive Check (pcVPC) of mixed-effect models.

Coordinating the compilation, drafting, and reviewing of clinical documents for submission to the health authorities in the EU and the US (Clinical summaries for CTD, Investigator brochure, IND, IMPD. Clinical study reports) Project lead MW.

Organizing clinical trials in Eastern Europe Providing expertise documents for clients

Writing Integrated (statistical and medical) Study Reports and publication drafts

Dissertation on "Fluctuations in Reaction-Diffusion Systems" (Promotor N.G. van Kampen)