Serving Medical Device Clients

TKL provides comprehensive services for the clinical development of medical devices. TKL meets the challenges faced by medical device clients by:

• Understanding of device regulations and submission requirements
• Taking responsibility for enrollment
• Understanding therapeutic indications in depth
• Utilizing optimum sites
• Meeting aggressive trial timelines
• Ensuring appropriate resource assignment
• Developing of an appropriate budget with the right cost per task
• Handling investigative products: importation licensing, US custom clearance, interim storage, labeling, kitting, distribution and destruction
• Managing global trials

TKL solutions include:

• Statistical analysis consultation for proper protocol subject-enrollment projections and overall study design
• Internal staff who develop a comprehensive trial design
• Realistic budget expectations and minimal change orders
• Monitors experienced with device trials
• Clinical experience and expertise in multiple medical-device therapies

For more about our CRO services

For more about our Research Clinics

For more about our Phase 1 Unit