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.
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 5-6 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