Datapharm Australia monitoring services have always been fundamental to our operations. Our extensive national and international experience over a wide range of therapeutic areas has brought Datapharm well deserved respect and admiration for the standard of monitoring services offered. Highly trained and experienced monitors have overseen studies from Phase 0 (exploratory, first in humans) to Phase IV (post-marketing surveillance) according to ICH GCP principles and local regulatory requirements. With major city presence across Australia, Datapharm is able to provide monitoring services where and when your company has a need, often without the burden of expensive travel costs.

Our clinical trial monitoring services include:

• Assistance with Investigator selection and site feasibility
• Assistance with subject recruitment strategies
• Development of monitoring plans, source data verification checklists and subject status tracking systems
• Investigator meetings
• Site Initiation Visits
• Clinical trial protocol training for site staff
• GCP training for site staff
• Routine monitoring visits with source data verification
• Pharmacy visits with product accountability review
• Monitoring Visit Reports to Sponsor and letter to Investigator after each visit to site
• Review of Investigator Site Files
• Creation and maintenance of a Trial Master File (TMF) both electronically and in hard copy
• Site close out visits
• Regular newsletters to sites
• Tracking of CRF review and collection