Early Phase Trials
Early Phase Clinical Research
Wakefield Early Phase Services include:
– Study Design and Protocol Writing
– Study project management
– Protocol development, Investigator Brochure (IB) and ICF writing
– Site identification and selection (including phase 1 units for healthy volunteer studies)
– Study implementation including ethics and regulatory coordination
– eCRF design and implementation
– Data management
– Biostatistics (including PK/PD analysis and modelling)
– Site management and monitoring
– Third party vendor management
– US entity & sponsorship
– Serious Adverse Event (SAE) reporting and Medical Monitoring
– Clinical Study Report (CSR) writing