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.
About Dr. Silverman
Dr Silverman’s views on clinical trial success have evolved from his many years of experience in a wide variety of drug development environments.
BioStrategics Consulting Ltd offers the following clinical development consulting services to pharmaceutical, biotechnology, and medical device companies:
A large part of the value that we add emerges from our ability to understand and integrate the 3 critical dimensions of clinical trial success:
A large Scandinavian healthcare company elected to explore diversification into the ethical pharmaceutical business.