The core activity of Stern Consult is the provision of consulting services to the pharmaceutical industry, particularly in the area of clinical research and development. This includes, among other things, the conduct of clinical trials, project management, clinical due diligence, clinical development strategy, clinical development plans, clinical governance, and the creation of clinical documentation.
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Clinical development consulting
Strategy, initiation, auditing and reporting for international Phase I–IV clinical studies; support for innovative life-science companies in the clinical development of drug candidates.
Project management for clinical development projects
Project planning, tracking and reporting, team leadership and training, budgeting and preparation of project documentation for clinical development projects.
Clinical trials management
Liaison with preclinical scientists, optimization of laboratory processes, selection and management of CMOs and CROs, as well as regulatory affairs management.
Clinical and product-related due diligence
Assessment of the clinical development strategy, development plans and governance, as well as analysis of the standard of care and the competitive landscape.
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