Early Phase Consultancy

Phase I studies enable the building of efficiencies into drug development plans while maintaining focus on safety, pharmakinetics and efficacy. Well structured, expert-led trials optimize the outcomes from the earliest phases of a clinical development strategy.

As a leading phase I-II contract research organization (CRO), we offer a comprehensive range of consultancy solutions to help you optimize your early phase clinical development strategy.

Our Experts Support:

• Clinical Development Plan (CDP)
• Study design
• Scientific advice preparation
• Protocol writing
• Development of supporting documents – e.g., Investigator Brochure (IB), briefing book and scientific articles 

Using innovative study design, including biomarker assessments, we ensure your study is regulatorily compliant while meeting your needs. Our teams will ensure your study is conducted in accordance with good clinical practices (GCPs) and conforms to a wide range of applicable standards, including those defined by the US Food and Drug Administration (FDA), European Medical Agency (EMA), International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), ISO and local regulatory bodies.

SGS is recognized as the benchmark for quality and integrity in early phase consultancy solutions. Whatever your objectives, our experts will help you ensure your trial reduces risks while optimizing outcomes.