SGS offers a complete early phase development package moving products through the pipeline safely and quickly.
Exploratory clinical trials
Including microdosing trials, early Proof of Concept, and biomarker studies.
First-in-human clinical trials
SGS conducts simple and complex FIH studies such as:
- Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD)
- Combined protocols: SAD/MAD + food + Proof of Concept (POC)
Regulatory Phase I trials
SGS provides not only safety assessments to comply with EMEA and FDA requirements, but a variety of additional information to facilitate your “GO – NO GO” decisions.
- QT/QTc Trials
- Drug-drug interaction studies including the bioanalysis of the markers of main cytochrome activities involved in metabolic interaction
- Pharmacokinetic studies in special populations (elderly, race, gender, renal insufficiency including CAPD, liver disease)
- ADME and Clinical Pharmacokinetics and Pharmacodynamics
- Bioavailability and bioequivalence (average and individual) studies including transdermal systems