Email this pageEmail this pagePrint this pagePrint this page
Share on LinkedInShare on LinkedInShare on FacebookShare on FacebookTweet thisTweet this

Life Sciences

Categories

Minimize menuMaximize menu

Minimize menuMaximize menuHomeLife SciencesBiopharmaceutical ServicesClinical Research ServicesClinical PharmacologyRegulatory Phase I Clinical Trials

Related Services & Resources

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.

TQT/QTc trials

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:
    • Elderly
    • Race
    • Gender
    • 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
Exploratory DevelopmentExploratory Development to Proof of Concept Integrated services reduce time to market (PDF 876KB) ...
Metabolic SyndromeMetabolic Syndrome: Trial Design Key PointsConducting a clinical trial in Metabolic Syndrome (PDF 98KB) ...
Interactive Pocket MapLife Science Services & Sites Pocket MapA quick reference to our global sites and services. ...

Contact

SGS Headquarters

  • 1 Place des Alpes
  • P.O. Box 2152
  • Geneva, 1211
  • Switzerland
  • t   +41 22 739 91 11
  • f   +41 22 739 98 86
  • e   Email Us

E-SUBSCRIPTIONS

Sign up to SGS publications and newsletters from your region and around the world
STAY UP TO DATE.SUBSCRIBE NOW

Office Directory

Find SGS offices and labs around the world.World map
Office Locator

News

events