sgs
Core business
SGS is a leading Life Science contract service organization providing clinical research, analytical development, biologics characterization, biosafety and quality control testing.
Delivering solutions for bio-pharmaceutical companies, SGS provides:
Clinical trial management and monitoring (Phase I to IV) services
Biometrics services: data management, biostatistics, PK/PD Modeling & simulation, medical writing
Regulatory and Medical Affairs consultancy.
Legal Representative
Johan Pype
Specific areas of activity
What do we do?
Early phase clinical trials
SGS’ clinical unit located in Antwerp - Belgium, with a total of 88 hospitalization beds and also two phase I patients units based in Belgium and Hungary, has successfully passed several US FDA inspections during recent years. For optimized early phase clinical trials, SGS features sample tracking for safety lab data interfaced with Oracle for PK samples, Full eSource clinic automation (EDC), GMP pharmacy for on-site formulation and a Biosafety Level 2 quarantine facility.
SGS has a wealth of expertise in:
First-In-Human studies
QT/QTc prolongation
Radio-labeled 14C ADME & PET scan trials
Viral challenge testing
Biosimilars and complex PK/PD studies
Late phase clinical trials
For a qualitative and faster patient recruitment across Americas and Europe, clients can also count on SGS’ hospital partners network, large data base of investigators and key opinion leaders with a high therapeutic expertise in:
Infectious Disease & HIV/HCV
Vaccines
Oncology
Respiratory
Clients benefit also from the favorable regulatory environment in Belgium with very short phase I trial approval.
SGS also offers GMP/GLP contract laboratory services that include analytical chemistry, microbiology, stability studies, bioanalysis, virology and protein analysis.
Auditing BioEquivalence Data Management Early Clinical Phases eCRF Investigator Network Laboratory Late phase IV Marketing / Sales Medical Advising Medical Writing Pharmacovigilance & Drug Preclinical Project Management Regulatory Safety Statistics Training & coaching Translation