Clinical Operation Services

Wakefield Clinical Research provides flexible clinical operations support for biotechnology, pharmaceutical, and medical device sponsors conducting clinical trials in the United States.

Study Startup
Site identification and feasibility • IRB/regulatory coordination • Site activation and initiation • Startup timeline management

Project & Site Management
Project oversight • Site management • Enrollment and milestone tracking • Risk management and issue resolution

Clinical Monitoring
Qualification, initiation, monitoring, and closeout visits • On-site and remote monitoring • Source data and regulatory review • Protocol deviation and safety oversight

Vendor Oversight
Laboratory, EDC, IRB, and specialty vendor coordination • Deliverable tracking • Issue escalation and resolution

Enrollment Support
Screening and enrollment tracking • Recruitment strategy • Site performance support • Additional site identification

Data Review & Study Oversight
EDC and query follow-up • Protocol deviation and safety review • Data cleaning • Database lock readiness

Study Closeout
Site and vendor closeout • TMF reconciliation • Outstanding data resolution • Records and archiving coordination

Wakefield provides hands-on senior oversight and direct access to experienced clinical operations professionals. We can provide comprehensive clinical operations support or complement a sponsor's existing team with selected services. As both a CRO and clinical research site, Wakefield brings practical insight into study execution from both the sponsor and site perspectives.

Planning a U.S. clinical trial? Contact Wakefield Clinical Research to discuss your program.