Selected Clinical Research Experience

Phase II | Oncology | Non-Muscle-Invasive Bladder Cancer | Multicenter 

Ongoing U.S. component of an international, multicenter Phase II clinical trial evaluating an investigational intravesical oncolytic therapy in patients with non-muscle-invasive bladder cancer. The study includes an initial safety run-in with DLT assessment followed by dose expansion and evaluation of efficacy and safety.  

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 Collection & Review • Statistical Analysis & TFL Oversight • Protocol Deviation & Safety Oversight  

Phase 2a | Oncology | Advanced/Metastatic Solid Tumors | Oncolytic Immunotherapy 

U.S. Phase 2a clinical trial evaluating intratumoral administration of an investigational oncolytic therapy as monotherapy and in combination with pembrolizumab in patients with advanced or metastatic solid tumors. The study includes dose-expansion cohorts evaluating safety, tolerability, and preliminary clinical activity.

Wakefield Role: U.S. CRO & Clinical Research Site

Wakefield Services:  Study Startup • Project & Site Management • Investigative Site Services • Patient Recruitment & Enrollment • Regulatory & IRB Coordination • Clinical Monitoring • Data Collection & Review • Safety Oversight • Data Analysis Support 

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 & Clinical Research 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

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.

Wakefield Role:  Regulatory Partner, CRO & Clinical Research Site  

Wakefield Services: U.S. Regulatory Strategy & FDA Submission Support • FDA Meeting Preparation & Support • 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