BioStrategics Consulting Ltd provides a range of management-level clinical development consulting services to the pharmaceutical and biotechnology industries, including:
Clinical development strategy and management, especially for development-stage companies
Conceptualization, implementation, and management of Phase 1, Phase 2, first-in-man, and proof-of principle clinical trials
IND planning and preparation
FDA and other regulatory authority submissions, meetings, and related interactions
Clinical strategic planning for small molecules, biotechnology products, immunotherapeutic agents, novel drug delivery technologies, and medical devices in virtually all therapeutic areas
New technology assessment, due diligence, and program planning
Clinical development advisory services to senior-level management (CEO, COO, CSO, BOD).
Since its founding in 1999, BioStrategics Consulting Ltd has provided clinical research leadership for:
More than 20 Investigational New Drug applications, Clinical Trial Applications, or similar regulatory submissions
Numerous first-in-man clinical trials, both in healthy volunteer and in target patient populations
Proof-of-principle clinical trials in a variety of therapeutic areas, including oncology, rheumatology, dermatology, ophthalmology, autoimmune disease, infectious disease, immunotherapy, endocrinology/metabolic disease, and hematology
Clinical trial operational teams on 4 continents
Multiple pre-IND and milestone meetings with FDA reviewing divisions
Due diligence, business development, partnership, and corporate strategic analysis projects of preclinical-, clinical, and commercial-stage projects.
