Assistance to existing Medical Affairs personnel; project creative consulting, publication and study plans, KOL engagement. Interim Medical Affairs staffing. Assistance with the design and operation of new Medical Affairs departments.
In depth analysis of clinical and/or bench data, including discussion of the strategic implications of findings. Statistical comparisons of subsets of data.
Preparation of proposals for investigator initiated studies. Preparation of protocols, data collection forms, budgets and submissions for Phase IV studies (e.g. IRB submission). Management of data collection, data analysis and manuscript draft preparation. Management of publication submission and revisions.
Review of protocols and analytical strategies for the collection and analysis of clinical and/or bench data. Discussion and preparation of methodologies for data analysis, including database design and statistical testing procedures. Third-party concept/project evaluations of technical feasibility, scientific and clinical merit.
Analysis of existing data to determine if publication is viable. Preparation of manuscripts on the basis of available data. Assistance to company R&D staff in designing and preparing data for publication.
Preparation and delivery of presentations on a wide variety of clinical and scientific topics (e.g., astigmatism and cataract surgery). Talks may be designed for product promotion or continuing education purposes.