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Clinical Pharmacology

PRA Health Sciences

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
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