Industry Provider Profiles
SGS Life Science Services
Company Type Services
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.
Through years of executing complex trials SGS has a wealth of
- 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
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
- 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.
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
- 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
For optimized and customized Project Management, SGS’s
- Centralized Project Management with multilingual senior Project
- 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
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.
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
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.
- Biopharmaceutical Testing
- Analytical Chemistry
- 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.
SGS Life Science Services
820 West Diamond Ave
Gaithersburg, MD 20878
SGS Life Science Services
1 place des Alpes
+ 41 22 739 91 11
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