AMR Stakeholder Profile
SGS Belgium NV
Focus area/active in: Therapeutics, Diagnostics, Human Health, One Health
Company/Organisation type: CRO | CMO
SGS – LIFE SCIENCES, CLINICAL RESEARCH SGS has over 35 years of experience as a life science, global contract service organization, providing integrated services organization providing integrated solutions from preclinical activities to Phase I-IV trials, Bioanalytical and Quality Control testing. With over 1,600 employees and 2,000 trials performed, SGS serves the pharmaceutical, biotechnology and medical device industries. SGS’ state-of-the-art facilities include a clinical pharmacology task force of three hospital embedded units, three bioanalytical labs and clinical trial management offices across Europe (incl. CEE) and North America for global Phase I-IV trial coordination. With broad clinical pharmacology experience, innovative study designs, top quality facilities, tailored biometrics services and strong regulatory intelligence, SGS can significantly improve clients’ drug development timelines and decision-making processes.
As one of the largest European early development CROs, SGS offers a complete range of services encompassing: Clinical Pharmacology Through years of executing complex trials in healthy volunteers and patients, SGS has a wealth of expertise in:
- First In Human trials: Single Ascending, Dose (SAD) & Multiple Ascending, Dose (MAD), combined protocols: SAD/MAD + food + POC
- Regulatory Phase I trials: Drug-drug interactions, Pivotal TQTc prolongation trials, PK and PD studies, BA/BE studies
- Exploratory Early phase trials: Early POC studies in patients, 14 C radiolabelled ADME studies, Biomarkers for clinical trials, Viral Challenge testing
- A large scope of biomarkers and clinical pharmacodynamic models With 88 hospitalization beds, including 20 unique quarantine beds (Biosafety Level 2Q), the SGS clinical unit in Antwerp, Belgium has successfully passed several US FDA inspections during recent years.
Clients benefit from the favorable regulatory environment with very short phase I trial approval times of two weeks, as well as a large database of over 10,000 volunteers and special population subjects. For complex early phase patient clinical trials, SGS has set up a network of hospital embedded in-patient clinical pharmacology units in Belgium and Hungary. Pre-clinical and bioanalytical With its GLP certified and FDA inspected bioanalytical laboratory network, SGS has an international reputation for assay of drugs in biological fl uids as well as for complex method development and validation.
SGS is organized as a full CRO to deliver on Time and on Budget Phase II-IV research services with a high-quality network of experts and sites, ensuring fast recruitment and sites activation. Whether you request a one-stop-shop service package or are interested in individual selected services, SGS is set up to accommodate your needs. Phase II-IV trial management Employing a team of over 100 individuals, highly trained in the latest International guidelines and company SOPs, SGS has conducted over 800 projects including trials with patients in Western, Eastern and Central Europe, Russia, and North America.
For high quality clinical trial execution, clients can count on SGS:
- Proven therapeutic expertise with a focus in Infectious, Cardiac and Neurological diseases
- Centralized Project Management with multilingual senior Project Managers
- Efficient Project Management tools such as CTMS, IVRS, central ECG reading, EDC
- Large database of investigators and key opinion leaders
- Site Management Organization (SMO) managing a network of clinical sites and hospitals for many disease areas
CLINICAL SUPPORT SERVICES
Drug Development Consultancy & Services As a standalone service SGS can assist in the development of molecules in early clinical phases Bringing impartial advice and solutions on development plans. We establish a dedicated multi-disciplinary team of qualified regulatory, toxicology, pharmacology, therapeutic area and biometric experts, who can assess projects and provide guidance to clients on how to reach a go/no go decision safer and faster. Data management/statistics and medical writing.
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 Oracle Inform ® , Merge sClinicalOS ® and Medidata Rave ® . Clients benefit from a knowledgeable, proactive staff with broad experience working with various EDC systems and e-CRF templates. SGS is fully CDISC compliant and successfully experienced in full electronic FDA submissions.
REGULATORY & MEDICAL AFFAIRS
- Regulatory Affairs department 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.
- Medical Affairs department provides full Phase I-IV pharmacovigilance services including Serious Adverse Event (SAE) handling, set-up and management of in-house safety database (Oracle Argus Safety), ADR reports, medical review and narrative medical writing, electronic reporting in Europe to Eudravigilance and Health Authorities.
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Business Development Manager
SGS Belgium NV
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