Regulating progress through expertise - A focused team for a diversified field
Our experienced team of specialists allows us to effectively design, manage and analyze your development programs and clinical trials in the highly diversified field of endocrine and metabolic diseases.
Our clinical trial experience spans:
- Design, management and monitoring of complex trials
- Close working relationship with investigators
- Experience in difficult to recruit populations
- Addressing of specific issues associated with e.g. diabetes and obesity trial management
- Successful navigation through the complexities and regulatory scrutiny of endocrine/metabolic development programs
- Regulatory handling in different countries
- Documentation
We have performed international first-in-man and first-in-patient studies up to post marketing studies and we have extensive experience in certain therapeutic approaches:
- Diabetes mellitus
- Osteoporosis
- Rare metabolic diseases
- Inborn or acquired liver-based metabolic disorders autoimmune diseases
- Lupus erythematosus
- Idiopathic urticaria
- Hypertension
- Hormone replacement therapy
- Erectile dysfunction
- Hyperlipidemia
David A. Katz, Sparrow Pharmaceuticals
Founder & CSO
A great partnership between Sponsor and CRO is the foundation of a highly effective drug development team. FGK impressed us with their open communication, professionalism, and commitment to the project from the start. The FGK team’s expertise across multiple functions has contributed substantially to our success. We look forward to continuing our strong collaboration.
Complex disorders require tailored solutions. Let’s discuss your next study.