How we can help

Assess the clinical landscape the technology is aiming to address

Evaluate strengths & weaknesses of current technologies

Define the unmet need and value proposition

Provide feedback on potential improvements that can be made to the technology

Assess potential clinical
risks associated with the technology

Guide clinical trial design

Assist with site selection

Support core lab selection

Participate in meeting with regulatory bodies

Management of regulatory process

Compliance with applicable laws

Adherence to regulatory requirements

Study protocol

All other essential study documents

Sponsor specific Standard Operating Procedures

Safety Plan, including Safety Committee Charters

Monitoring Plan

Study budget

Ongoing Study Management

Independent Study Monitoring

Case Support