Early Phase I - IIa Services

The point at which a drug moves from preclinical testing to Phase I clinical research marks an important milestone for a pharmaceutical or biotechnology company, being the point at which in-human testing begins.

Safety is, of course, the number one priority, but SGS Early Phase I–IIa Services also place importance on getting products through trials and to the market as quickly as possible to give your business a competitive advantage. As the leading Phase I contract research organization (CRO), SGS has an international reputation for complex study design for clinical pharmacology trials that give clients an insight into a drug candidate’s:

• Safety
• Tolerability
• Pharmacokinetics
• Pharmacodynamics

Our aim is to give you the opportunity as early as possible to make a ‘go / no go’ decision’ while meeting regulatory standards.

Our highly skilled and trained experts will work with you to determine your early phase clinical strategy, designing trials that are based on your particular circumstances and the demands of international and local regulations. Through them, you will have access to the most recent pharmacodynamics models, biomarker targets and data management techniques that work together to form a cohesive clinical trial program.

Our services are provided at a Phase I Unit – located in Antwerp, Belgium – with 92 beds in total. Our facility employs the latest technologies and has successfully met the standards of the US FDA, GCP, ICH, ISO guidelines and directives and local regulatory bodies. Through SGS you will have access to a database of 10,000 potential trial participants, including special populations.

With over 35 years’ experience in Phase one trial design and implementation, SGS Life Science Services are particularly well placed to meet your clinical trial needs. We offer a trusted and experienced pair of hands to guide you through early phase trials quickly and safely.