Study Start Up

Our staff have extensive experience in study start up activities and are committed to achieving site initiation in the shortest possible timeframe.  We will ensure that start up for your study is optimized, building in efficiencies and economies of scale at every opportunity without compromising on quality.  Importantly, we make certain that the appropriate CRA resource levels are allocated to this critical period of study.

Our Start-up services offered include:

• Study Feasibility
• Site Identification / Selection
• IEC Submission
• Regulatory Document Preparation and Submission
• Import Permit Preparation and Submission
• Clinical Trial Research Agreement Preparation
• Essential Document Preparation, Dissemination and Collection
• Site Activation and Authorisation for Initiation
• Coordination of Initial IP/Device Shipment
• Trial Master File Set-Up
• Investigator Meeting Organisation