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
SGS, as one of the leading early clinical development CRO’s with partners specialized in cardiac data reading (ECG/Holter), has developed a strong expertise providing high-quality ECG reading and analysis in QT Prolongation & Safety Pharmacology studies to the Pharmaceutical and Biotech Industries.

SGS performs 4-5 QT/QTc studies per year with an average of 24,000 ECG / trial

• Compliance with the latest regulatory guidelines (FDA, ICH), 21 CFR part 11 compliance
• Unmatched reading accuracy : allowing reduction of sample size
• High reading accuracy
• 100% digital workflow
• Strong reproducibility: Intra < 1 ms, Inter < 2 ms

Pivotal Pharmacokinetic Study

• 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 - Clinical Pharmacokinetics & Pharmacodynamics
• Bioavailability and bioequivalence (average and individual) studies including transdermal systems