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
- IND planning and preparation
- Conceptualization, implementation, and management of Phase 1, Phase 2, first-in-man, and proof-of principle clinical trials
- FDA and other regulatory authority submissions and meetings
- 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 clinical 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 25 Investigational New Drug applications, Clinical Trial Applications, or similar regulatory submissions
- Multiple pre-IND and milestone meetings with FDA
- Numerous first-in-man clinical trials, both in healthy volunteer and in target patient populations
- Proof-of-principle clinical trials in oncology, rheumatology, dermatology, ophthalmology, autoimmune disease, infectious disease, immunotherapy, endocrinology/metabolic disease, and hematology
- Clinical trials programs that align with business success, efficiently achieve value inflection points, and have (in some cases) enabled advantageous exit events
- Clinical trial operational teams on 4 continents
- Due diligence, business development, partnership, and corporate strategic analysis projects of preclinical-, clinical-, and commercial-stage projects.