Clinical Pharmacology, Clinical Trial Design, Clinical Trial Monitoring, Data Management, Inpatient/Outpatient Facilities, Mass Spectrometry, Pharmacokinetic/Pharmacodynamic Modeling, Project Management, Statistical Services/Meta Analysis, Trial Management
SGS’ Life Science Services has 30 years of experience as a global contract service organization providing integrated solutions from preclinical activities to Phase I-IV trials, Bioanalytical and Quality Control testing. SGS’ state of the art facilities include: 2 Phase I units with a total of 172 beds, 2 bioanalytical labs, and Phase II-IV clinical trial management offices across Europe and North America.
Clinical Pharmacology: SGS’s clinical units in Antwerp, Belgium, and Paris, France, have a wealth of experience in First in Man, PK/PD, BE/BA, interaction, C14 ADME and Proof of Concept trials. Clients benefit from favorable regulatory environments in with very short phase I trial approval times of two and four weeks, respectively.
Bioanalysis: A GLP certified and FDA inspected laboratory network, SGS has an international reputation for assay of drugs in biological fluids and complex method development & validation. Services include: Drug sample bioanalysis (26 LC-MS/MS), Animal metabolite profiling and balance studies (14C-labelled drug), Toxicicokinetic analyses and In-vitro cell-assays, Immune function testing: immunogenicity, flow cytometry, cytokine multiplexed ELISA.
Phase II-IV Management: SGS has conducted over 800 Phase II-IV trials with patients in Western, Eastern and Central Europe, Russia, and North America. Monitoring and management offices are located in the USA, France, Spain, Czech Republic and Poland.
Biometrics: As one of the largest independent data management teams in Europe, SGS supports all in-house and external project needs for clients’ clinical trials, powered with Clinitrial®, Oracle Clinical® and SAS®. SGS is fully CDISC compliant and successfully experienced in full electronic FDA submissions.
SGS Regulatory Affairs offers consulting in both European and U.S. registration of Biotech and, Prescription drugs, veterinary products and medical devices with comprehensive EMEA and FDA authorities’ expertise.
Pharmacovigilance services such as SAE and ADR reporting, medical writing of PSURs, safety reports and expert reports are also available.
Outsourcing of skilled staff to adjust the size of your project team to the current workload
Europe North America
Contact: Cedric Volanti Contact: Ronald Baker
+41 22 739 94 11 +1 877 677 2667
When you need to be sure about your CRO