Our experience & therapeutic areas
Whether you are experiencing a challenging pharmaceutical trial, a project that is slow to progress, or your trial has come to a standstill, we can get it back on track with our deep knowledge and experience of site, vendor and trial management, operations, and regulatory affairs.
Some of our references in pharma and biotech
With 20+ years of experience and nearly 100 clinical trials, these are some of the companies we have worked with:
Clinical trials therapeutic areas
We have experience in over 20 therapeutic areas:
- Allergology
- Cardiology
- Dermatology
- Diabetes
- Gastroenterology
- Gynecology
- Immunology
- Infectious diseases
- Metabolic disorders
- Neonatology
- Nephrology
- Neurology
- Oncology
- Ophthalmology
- Pediatric studies
- Pulmonology
- Rare disease
- Respiratory diseases
- Surgery
- Urology
Orphan drugs
Orphan drugs are medicinal products intended to diagnose, prevent or treat rare diseases, which are diseases affecting less than 1 in 2,000 persons or a maximum of 250,000 citizens in the European Union.
The Orphan Drug Designation is a legal process that enables the designation of a medicinal substance with therapeutic potential for a rare disease, either prior to its initial use in humans or during its clinical development.
ATMPs
Advanced therapy medicinal products (ATMPs) are cutting-edge biologics pioneering a relatively new field of precision medicine. The ATMP-specific Good Manufacturing Practice (GMP) guideline focuses on a risk-based approach, and this way of thinking is crucial in this novel and complex field where there is a perpetual interplay between known and unknown risk factors.