Clinical Pharmacology

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