For certain Phase I-IIa study designs where enrollment of special populations or patients will be the limiting factor, WCCT has collaborated with other North American Clinical Pharmacology Units to provide a complete study solution. The cornerstone of this highly successful model is the overall agreement between the sponsor and WCCT and the management of the collaborative sites by WCCT.
In this setting, through a combination of WCCT employees and trusted research partners, enrollment rates are greatly accelerated while decreasing the additional financial burden of contracting with a large, traditional CRO which would manage CPU.
WCCT provides the following services:
- Protocol design and writing
- CPU site selection and qualification
- Clinical conduct of a portion of the study at WCCTs two clinics
- Site Monitoring
- Medical Monitoring and Pharmacovigilence
- Data Management
- Biostatistics
- Pharmacokinetics
- Medical Writing