EARLY PHASE TRIALS IN AMERICA

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

@ Copyright 2021, Ladiom