SGS, LIFE SCIENCES – CLINICAL RESEARCH
SGS is a leading life science CRO providing clinical research and bioanalytical testing with a specific focus on early-stage development and biometrics.
Delivering solutions in Europe and in the Americas, SGS offers clinical trial (Phase I to IV) services encompassing full early phase drug development consultancy, clinical project management and monitoring, medical writing, data management, secure data office, biostatistics, PK/PD modelling & simulation and pharmacovigilance & regulatory services.
Early Phase Development
Drug Development Consultancy
SGS proposes its extensive knowledge, gained from our work with regulatory agencies worldwide, and unique early phase clinical trials background with big pharma and small biotechs. Our experts are trained to meet the requirements of international guidelines, such as GCP, ICH, EMEA/CPMP, the FDA and other important regulatory bodies. SGS also offers development coaching, focusing on a high-level overview of your file to guide you to the required development steps for optimizing your compound.
SGS comprehensive range of services includes:
- Early phase development strategy and tactics:
- Validation of strategy with regulators:
- Development and redaction of official health authorities’ trial documents
- Scientific and medical input
SGS has a wealth of expertise in: First-In-Human studies, QT/QTc prolongation, radio-labeled 14C, Human Challenge Testing, ADME & PET scan trials. Clients benefit also from the favorable regulatory environment in Belgium with very short phase I trial approval times of two weeks.
Thanks to the central locations of the clinical pharmacology units, SGS has built large databases of Healthy Volunteers, special population subjects and patients including renal & hepatic impaired, postmenopausal and sterilized women, elderly, slow metabolizer, obese, diabetic and asthmatic subjects. Rapid access to volunteers and special patient populations provides clients with the recruitment edge to execute time-critical trials.
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
- 14C-radiolabelled ADME studies
- CSF sampling
- Human Challenge Testing
For optimized early phase clinical trials, SGS features:
- 3 clinical pharmacology units (Belgium and Hungary)
- Sample tracking for safety lab data interfaced with Oracle for PK samples
- Full eSource clinic automation (EDC)
- GMP pharmacy for on-site formulation
- Biosafety Level 2 quarantine facility for Human Challenge testing
Global Clinical Trial Management
Phase I – IV Trial Management
SGS is organized as a full CRO provider to deliver on Time and on Budget Phase I-IV clinical research services.
Employing a highly trained team in the latest International guidelines and company SOPs, SGS has conducted over 850 projects including trials with patients in Western, Eastern and Central Europe, Russia, and North America. SGS’ monitoring and management offices are located in Belgium, France, the UK, the Czech Republic, Poland and USA.
SGS Clinical Trial Management services include:
- Protocol/study design
- Project Plan
- Monitoring guidelines
- Site evaluation
- Site qualification
- Interim management
- Investigator screening
- IEC/IRB submission
For qualitative and faster patient recruitment, clients can count on SGS’:
- Large database of investigators and key opinion leaders
- High therapeutic expertise in :
- Infectious Disease & HIV/HCV
- Site Management Organization (SMO) manages a network of clinical sites and hospitals for many disease areas, eg. Alzheimer’s, diabetes, HIV, nephrology, neurology, oncology, respiratory diseases (COPD), psychiatry, rheumatoid arthritis, urology and paediatrics
Biometrics – Data Management, Statistics and Medical Writing services
SGS biometric group of 290 people is organized for flexible allocation and easy scale-up of resources to meet small, medium and large pharma companies’ needs. Early adopters of integrated IT solutions such as E-source or Argus safety database and pioneers in full EDC application with multi EDC systems from phase I to post-marketing, SGS is a CDISC registered solution provider and has successfully experienced full electronic FDA submissions for several candidate drugs.
Our comprehensive services include:
- Electronic solutions: develop, test and release Electronic Data Capture (EDC), electronic Clinical Outcome Assessment (eCOA), Interactive Voice/Web Response System (IVRS/IWRS) and integration of external data loads into the eCRF
- Data management: SDTM compliant, clean clinical database, ready for submission
- Secure data office: handle all data of potentially unblinding nature (PK/PD, lab, randomization)
- PK/PD data analysis: CDISC compliant PK/PD datasets, PK/PD data analysis and reporting
- Biostatistics: advice on protocol design, SAP development and delivery of ADaM compliant datasets and statistical analysis
- Medical writing: a wide range of clear, cohesive and rigorous study documents, fully compliant with ICH-E3, regulatory and your own requirements
- Project Management Biometrics: oversight of all biometrics, drug safety and pharmacovigilance key deadlines and deliverables
Medical and Regulatory Affairs
SGS Medical and Regulatory Affairs group offers consulting in both European and U.S. pharmacovigilance and registration of Biotech and, Prescription drugs, veterinary products and medical devices, with comprehensive EMEA and FDA authorities’ expertise.
Whether you are an EU-based or non-EU company, SGS Medical and Regulatory Affairs provides full regulatory and safety services from pre-clinical to post-marketing, including
- Pre-registration consultancy, to scientific advice requests, regulatory submission and pharmacovigilance strategies
- Preparation and review of IMPD / IB
- Fast and tailor-made safety solution to help you meet your safety requirements (Trace®)
EUROPE – Tel: +32 15 27 32 45
NORTH AMERICA – Tel: + 1 877 677 2667
Follow us on LinkedIn: www.linkedin.com/company/sgs-life-sciences