This is a summary of the services that I can provide.
Medical Writing
Medical Writing
- Preparation of protocols and clinical trial reports and informed consent forms for Phase I-IV clinical studies
- Production of Investigator Brochures
- Preparation of Clinical Pharmacology expert reports for inclusion in INDs, BLA, NDA and MAAs
- Preparation of agendas and minutes for internal and external scientific meetings
- Proof reading and editorial reviews of a wide variety of clinical documents
Presentations/Publications
- Creation of presentation material for Investigator meetings, scientific symposia, Health Authority Meetings
- Preparation of abstracts and manuscripts for publication in peer reviewed journals
Early Clinical Development Strategy
- Strategic input to the design and implementation of clinical development plans for the purpose of IND, NDA/MAA submissions
- Design of studies and interpretation of data for clinical pharmacology programs
Training Documentation
- Creation of training manuals for internal processes
- Creation of training material for clinical trial sites
- Production of patient education material
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