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. With over 1,300 employees and 2,000 trials performed, SGS serves the pharmaceutical, biotechnology and medical device industries.

SGS’ state of the art facilities include two Phase I units with a total of 162 beds, three bioanalytical labs, and Phase II-IV clinical trial management offices across Europe, North America & Asia. 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 Neurological diseases.

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.

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)
  • Integrated 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
  • C14-radiolabelled ADME studies
  • Biomarkers for clinical trials
  • Microdosing trials: AMS & PET

SGS’ clinical units in Antwerp, Belgium, and Paris, France, have successfully passed several US FDA inspections during 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 15 000 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 (24 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.

Phase II – IV Trial Management

SGS’ Life Science Services 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.

Employing a team of 150 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. SGS’ monitoring and management offices are located in France, Spain, UK, Netherlands, Czech Republic, Poland, USA and Singapore.

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

• 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’ 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.

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. 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.

Outsourcing

SGS’ Outsourcing department can provide clients with skilled staff to temporarily increase the size of a project team in order to meet current workload needs and give clients the flexibility to execute projects effectively.

Pharmacoeconomic & Health Outcome Research

SGS works with clients to design, conduct, and analyze pharmacoeconomic and post-marketing studies through a dedicated team of statisticians and medical writers with extensive experience in these fields.

To complete its global portfolio, SGS operates the largest international network of quality control testing laboratories with 16 facilities in 12 countries. These services include analytical chemistry, microbiology, stability studies, method development, toxicology, and protein analysis.

With over 48,000 employees, 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.

Contact Information

SGS Life Science Services
Headquarters:
1 place des Alpes
Geneva 1211 Switzerland
Phone: + 41 22 739 91 11
Fax: + 41 22 739 98 86
E-mail:

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