Our clinical team have almost 20 years’ experience working on 500+ early phase studies, making us an exceptionally experienced local provider within the America market and a partner of choice for many international biotech companies.

OUR EARLY PHASE SERVICES INCLUDE:

• Full study project management – regional and international
• Protocol development & Investigator Brochure (IB) writing
• Site identification and selection (including phase 1 units for healthy volunteer studies)
• Study implementation including ethics and regulatory coordination
• eCRF design and implementation
• Full data management
• Biostatistics (including PK/PD analysis and modelling)
• Site management/monitoring
• Third party Pathology/Bioanalytical laboratory analysis & reporting
• Serious Adverse Event (SAE) reporting and Local Medical Monitoring (LMM)
• Clinical Study Report (CSR) writing