Just In Time (JIT) Team Approach

Kenneth Wu and Associates, LLC, are independent consultants in clinical operations and quality, dedicated to serving small to mid-size device and biopharmaceutical companies.  Small innovative companies now have access to highly experienced clinical professionals, who work within budgets and time constraints. 

Clients call for 

• clinical operations expertise on device and biopharrmaceutical trials
• experience with FDA and ISO compliance
• a flexible expert team to deliver trials on time   

Clients call when

• the immediate crisis requires an expedited successful outcome
• developing best practices is critical for speed and a successful submission
• funding is finite- but new problems seem endless

Unlike hiring other consultants and contract research organizations (CROs), an expert team will manage the entire clinical trial from protocol development to clinical study report.  Our consultants can be much more affordable and cost efficient than CROs. A seasoned clinical leader will manage project resources, timeline and budget to optimize efficiencies.  

Small companies benefit directly from significant cost savings and expertise of highly competent professionals.