Regulatory Phase I Clinical Trials
SGS is one of the world’s leading early clinical development contract research organizations.
Our clinical Phase I Unit provides clients with a full range of clinical research services compliant with EMEA and FDA requirements to facilitate your “go/no go” decisions during clinical development. We offer a large range of Phase I studies including drug interaction (DDI), TQT/QTc, as well as BA/BE and ADME/pharmacokinetic studies.
SGS performs five to six TQT/QTc studies per year with an average of 24,000 ECGs per trial. We offer:
- Compliance with the latest regulatory guidelines (FDA, ICH), 21 CFR part 11 compliance
- Unmatched reading accuracy and low variability (intraSD < 1 ms, interSD < 2 ms) allowing reduction of sample size
- 100% digital workflow
With partners specializing in cardiac data reading (ECG/Holter), we have developed a strong expertise in providing high-quality ECG reading and analysis in QT prolongation and safety pharmacology studies to the pharmaceutical and biotech industries.
Drug-Drug Interaction (DDI), Bioavailability/Bioequivalence (BA/BE), ADME/Pharmacokinetic Services:
- Drug-drug interaction studies including assay of the interacting drug (many validated methods available)
- Pharmacokinetic studies in special populations, including:
- Renal impairment, including dialysis
- Liver impairment
- Absorption, distribution, metabolism and excretion (ADME) –C14 labeled trials, including full GMP manufacturing of the medications
- Clinical pharmacokinetics and pharmacodynamics
- Bioavailability and bioequivalence studies including transdermal systems
Contact SGS today to learn how we can help with your early Phase I clinical trials.Email us
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