SGS Life Science Services

SGS Company Overview

SGS’s Life Science Services is a leading contract service organization providing clinical research services, analytical development, biologics characterization, and quality control testing. We serve a variety of Life Science companies including pharmaceutical, biopharmaceutical, biotechnology and medical device manufacturers. SGS provides clinical trial management (Phase I to IV) and services encompassing data management, statistics, regulatory consultancy and pharmacovigilance. Our laboratory services complete our portfolio by offering bioanalytical and immunogenicity testing, analytical chemistry, microbiology, stability studies, method development and validation, and extractables and leachables. With the acquisition of M-Scan, SGS extends it service expertise in protein/glycoprotein biopharmaceutical characterization using high-end mass spectrometry.

SGS Life Science Services is a truly global organization with approximately 1300 employees, located in 25 facilities, in 14 countries.

SGS’s state of the art facilities include two Phase I units with a total of 172 beds, three bioanalytical labs, and seven Phase II-IV clinical trial management offices across Europe and North America. SGS has a recognized clinical research expertise in the following therapeutic areas and diseases: Infectious diseases including HIV and vaccines, Respiratory (asthma, COPD), Cardiac diseases and coagulation, Inflammation, and CNS diseases.

Contact Information

Global Headquarters:
SGS Life Science Services
1 place des Alpes
Geneva 1211
Switzerland
+ 41 22 739 91 11
lss.info@sgs.com
www.sgs.com/CRO
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Early Phase Development

Clinical Pharmacology

Through years of executing complex trials SGS has a wealth of expertise in:

  • First In Human trials
    • Single Ascending Dose (SAD)
    • Multiple Ascending Dose (MAD)
    • Combeined protocols: SAD/MAD + food + Proof-of-Concept
  • Regulatory Phase I trials
    • Drug-drug interactions
    • Pivotal TQT/QTc prolongation trials
    • PK and PD studies
    • BA/BE studies
  • Exploratory Early phase trials
    • Early Proof-of-Concept studies in patients
    • C14-radiolabelled ADME studies
    • Biomarkers for clinical trials
    • Microdosing trials: AMS & PET
    • CSF Sampling

SGS’s clinical units in Antwerp, Belgium, and Paris, France, have successfully passed several US FDA inspections in recent years. Clients benefit from the favorable regulatory environment in the two countries with very short phase I trial approval times of two and four weeks, respectively.

Thanks to the central locations of the clinical pharmacology units, SGS has built a large database of 16,500 Volunteers and special population subjects including healthy subjects, renal & hepatic impaired, postmenopausal and sterilized women, elderly, slow metabolizer, obese, diabetic and asthmatic subjects.

Pre-Clinical & Bioanalytical Services

With its GLP certified and FDA inspected bioanalytical laboratory network, SGS has an international reputation for assay of drugs in biological fluids as well as for complex method development and validation. SGS offers:

  • Drug sample bioanalysis (31 LC-MS/MS)
  • Animal metabolite profiling and balance studies (14C-labelled drug)
  • Toxicokinetic analyses and In-vitro cell-assays
  • Immune function testing: immunogenicity, flow cytometry, cytokine multiplexed ELISA

For continuous increases in efficiency, benefiting clients, SGS consistently adopts the latest technologies in all critical aspects of laboratory science including: latest generation of LC-MS/MS, Turboflow, Qtrap, multiplexing, Watson LIMS.

Late Phase Development

Phase II – IV Trial Management

SGS is organized as a full CRO provider to deliver on Time and on Budget Phase II-IV clinical research services. Whether you request a one-stop-shop service package or are interested in individual selected services, SGS is set up to accommodate your needs.

Our team of experts is 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. SGS’s monitoring and management offices are located in the UK, Belgium, France, Spain, Czech Republic, Poland and USA.

For a qualitative and faster patient recruitment, clients can count on:

  • Large data base of investigators and key opinion leaders
  • Site Management Organization (SMO) managing a network of clinical sites and hospitals for many disease areas, eg. Alzheimer, diabetes, HIV, nephrology, neurology, oncology, respiratory diseases (COPD), psychiatry, rheumatoid arthritis, urology and paediatrics.

For optimized and customized Project Management, SGS’s organization includes:

  • Centralized Project Management with multilingual senior Project Managers
  • Efficient Project Management tools such as CTMS, IVRS, central ECG reading, EDC
  • Experience in E-Filing to FDA, CDISC
  • Regulatory Intelligence coverage for 76 countries
  • Medical Affairs Department with developed relationships with appropriate Health Authorities

Data Management, Statistics & 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 Clinitrial®, Oracle Clinical® and SAS®. Clients benefit from a knowledgeable, proactive staff with broad experience working with various EDC systems and e-CRFs templates. SGS is fully CDISC compliant and successfully experienced in full electronic FDA submissions.

Clinical Support Services

Regulatory & Drug Safety

  • Regulatory Affairs department offers consulting in both European and U.S. registration of Biotech and, Prescription drugs, and medical devices with comprehensive EMEA and FDA authorities expertise. SGS has established strategic submission plans using extensive country specific regulatory intelligence covering 76 countries.
  • Medical Affairs department provides full Phase I-IV pharmacovigilance services including Serious Adverse Event (SAE) handling, ADR reports, medical review and narrative medical writing, electronic reporting in Europe to Eudravigilance and Health Authorities.

Analytical Laboratory Testing

With an harmonized network of 17 laboratories in USA, Canada, Germany, France, Belgium, India, Thailand, Singapore, Taiwan, China, the R&D / QC Services Team provides regulatory compliant (GMP and/or ISO) analytical services to the clients. All laboratories have been inspected by local regulatory authorities and where applicable, the US-FDA. One global Quality Manual, harmonized SOP’s and process flow, global QA, and a standardized LIMS system ensure consistent high quality services across all laboratories.

Services

  • Biopharmaceutical Testing
  • Analytical Chemistry
  • Microbiology
  • Method Development & Validation
  • Stability Studies
  • Safety Testing
  • Extractables and Leachables
  • Medical Device Testing

Team up with SGS for your R&D and Quality Control Testing

  • Global harmonized network of analytical labs and consultancy in major markets
  • An organization with quality control testing as its core competence
  • Analyses performed under cGMP, GLP, ISO 17025, and ISO 9001
  • Comprehensive breadth and depth of tests performed in one source
  • Industry leading turn-around times

The SGS Group is the global leader and innovator in inspection, verification, testing and certification services. Founded in 1878, SGS is recognized as the global benchmark in quality and integrity. With more than 64,000 employees, SGS operates a network of over 1,250 offices and laboratories around the world.

North America Office

SGS Life Science Services
820 West Diamond Ave
Gaithersburg, MD 20878
USA
Tel: 1-877-677-2667
Email: lss.info@sgs.com

Contact Information

Global Headquarters:
SGS Life Science Services
1 place des Alpes
Geneva 1211
Switzerland
+ 41 22 739 91 11
lss.info@sgs.com
www.sgs.com/CRO
View Map

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