Our Experience
Our team, collectively, has been responsible for the design, protocol development, initiation, monitoring, data management, statistical analyses, and medical writing of hundreds of Phase I to IV clinical trials. These studies ranged from small pharmacokinetic crossover trials to long-term global multi-center studies.
As former pharmaceutical company professionals and at PROMETRIKA, we have developed and compiled NDAs and CTDs, including integrated summaries of safety and efficacy.
We have experience in a variety of therapeutic areas, including:- Allergy/Respiratory
- Cardiovascular Disease
- Central Nervous System
- Dermatology
- Endocrine/Metabolic
- Gastroenterology
- Infectious Disease
- Inflammatory Disease
- Medical Devices
- Oncology
- Ophthalmology
- Orphan Drugs
- Pediatrics
- Phase I: PK/PD, First-in-Man
- Urology
- Women’s Health