Biotech Development Hub

Experts for Time & Cost Savings Biotech Drug developments
Demonstrating the Proof Concept of a biopharmaceutical drug candidate as early in the clinical program as possible is a prime objective of any drug development program. It is the most important step for:

• Proving future value and either moving the investigational medicinal product (IMP) into late phase trials or
• Successfully negotiating an out-licensing agreement with a pharmaceutical partner.

SGS Life Science Services offers one on one consulting and a tailored package of services, stand alone or full program, enabling Biotech companies to efficiently and successfully achieve the objectives of their Clinical Research Program.

SGS LIFE SCIENCE SERVICES ADVANTAGES
Choosing SGS Life Science Services Early Clinical Research Package provides the following operational efficiencies to Biotech companies:

• Fast Regulatory approvals (EC/CA) in Belgium & France (2-3 weeks)
• Experienced staff who have lead a large number of clinical projects on a wide variety of candidate drugs
  • large experience in pharmacodynamic techniques
• Fast track development:
  • combined SAD/MAD
  • intricate study design
  • online PKPD modelling: rapid access to critical data on dose/response relationship
• Access to therapeutic opinion leaders (internal and external)
• Early implementation of standard data management and pharmacovigilance systems for use in future late phase clinical trials
• Scientific expertise to help oversee critical aspects of IMP development program
• Full regulatory support services from pre-clinical to post-marketing
• Successfully FDA inspected: 5 times

SERVICES & TECHNOLOGY

• First in human: large capacities - 74 intensive care hospitalization beds
• Bioanalytics: GLP compliant labs for LCMS and immuno-analyses for TK and clinical PK
• Biomarkers: comprehensive capabilities for immuno-analyses of biomarkers (ELISA, multiplex), and FACS analysis   
• Data management/biostatistics: global services with large EDC and IVRS experience
• Efficacy clinical trials in patients: extended capabilities for clinical trials in Western EU, Eastern EU, and Russia
• Pharmacovigilance: global handling including electronic reporting to EU Eudravigilance
• Regulatory affairs support for global trials: CTA, Ethics Committees
• Scientific consulting to support CTA and clinical programs