Early-Phase & PK Study Expertise

Wakefield Clinical Research has specialized capabilities supporting: 

– Phase I–II clinical studies (healthy volunteers and patients)
– Drug-drug interaction studies
– Intensive PK sampling
– PK/PD analysis support
– Clinical pharmacology studies

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