Clinical Operations

We provide comprehensive clinical support for global Phase I-IV studies from start‑up to close‑out. Our cross-functional team of scientific and clinical operations experts will work with you and your strategic partners to anticipate and meet any challenges of complex program design, clinical trial conduct, and regulatory approval.

Support services are customizable and can include:

Project management
Project feasibility/clinical trial design
Clinical site selection
Study start-up (including ethics submissions oversight, SIV, IM, contract negotiations)
Subject recruitment
Continuous clinical site training, management, and monitoring
Database set-up and maintenance
Medical monitoring
Risk management
Medical writing
Local & global safety reporting
Management of third party vendors
Clinical site/trial closeout
TMF management and transfer