Protocol design – Collaborate with Sponsor, while following international guidelines

IRB Management – Submission and communication with Institutional Review Boards

Regulatory Documentation – Preparation and maintenance of compliant regulatory files

CRFs, ICFs, & Health Forms – Tailored to study. Experienced with multiple EDC platforms

Data Collection – Accurate, complete, and timely

Data Analysis – Interim and final data analysis for regulatory submission

Dedicated Monitoring Services – Risk-based monitoring