Selected Experience

NMIBC Bladder Cancer Study — Ongoing

Phase I | Oncology | Non-Muscle-Invasive Bladder Cancer | Dose Escalation

Ongoing U.S. multicenter Phase I clinical trial evaluating an investigational intravesical oncolytic therapy in patients with non-muscle-invasive bladder cancer. The study includes dose escalation, safety and tolerability assessments, and Safety Review Committee oversight.

Wakefield Role: U.S. CRO

Wakefield Services: U.S. Study Startup • Site Identification & Qualification • Project & Site Management • Regulatory & IRB Coordination • Clinical Monitoring • Enrollment Oversight • Vendor Coordination • Data Review Support • Protocol Deviation & Safety Oversight • Study Closeout

Gout Drug–Drug Interaction Study —Completed

Phase 1b | Gout | Pharmacokinetics / Drug–Drug Interaction

U.S. Phase 1b clinical study evaluating the pharmacokinetic interaction between an investigational URAT1 inhibitor and allopurinol in patients with gout. The study also evaluated pharmacodynamic effects on serum uric acid and the safety and tolerability of the treatments.

Wakefield Role: CRO & Investigative Site

Wakefield Services: Protocol Development • Study Design & Startup • Investigative Site Services & Patient Enrollment • Project & Site Management • Regulatory & IRB Coordination • Clinical Monitoring • PK/PD & Laboratory Coordination • Vendor Oversight • Data Review & Database Lock Support • Statistical Analysis & TFL Oversight • Clinical Study Report (CSR) Development • Study Closeout

Diode Laser Hair Removal Human Factors Validation —Completed

Medical Device | Human Factors / Usability | OTC

U.S. human factors validation study of an over-the-counter diode laser hair-removal device. The study evaluated user self-selection, product labeling, critical tasks, and simulated device use in an intended home-use environment. The protocol confirms that the study was designed as a U.S. simulated-use human factors validation study consistent with FDA human factors guidance.

Wakefield Role: Regulatory, CRO & Investigative Site Support

Wakefield Services: U.S. Regulatory Strategy & FDA Submission Support • FDA Meeting Preparation & Interaction • Protocol Development • Human Factors Study Design • IRB & Study Startup • Participant Recruitment • Study Conduct • Data Collection & Analysis • Risk Assessment • Final Study Report Development • Regulatory Submission Support

Additional Quality & Consulting Experience

GCP Site Audit

Clinical Quality Assurance | Investigator Site Audits

Conducted independent GCP audits of investigator sites across three clinical studies, evaluating study conduct, source documentation, regulatory compliance, protocol adherence, and inspection readiness.

Vendor Audit

Quality Assurance | Vendor Qualification & Compliance

Conducted two independent vendor audits to assess quality systems, procedures, documentation, and compliance with applicable clinical research requirements.

Clinical Development Consulting

Strategic & Operational Consulting

Provided clinical development consulting to ten biotechnology sponsors, supporting clinical strategy, study planning, operational considerations, and U.S. clinical development activities.