Clinical Trial Management

Datapharm Australia has been involved in several hundred projects since 1987, and is well known and respected for providing expertise in clinical trial management for the pharmaceutical and biotechnology industries.

We are highly experienced in running both national and international drug and device trials, across many therapeutic areas, and in all developmental phases from Phase 0 (exploratory, first in humans) to Phase IV (post-marketing surveillance).

All clinical trials are managed and monitored according to ICH GCP principles and local regulatory requirements. We are happy to help with the services you require, and our nation-wide team of well-trained and experienced CRAs reduces the burden of expensive travel costs which can be associated with the monitoring and management of trial sites.

Our clinical trial management services include:

• Clinical trial design
• Protocol preparation/review
• Investigator selection and site feasibility
• Ethics submissions and informed consent document preparation (by our specialised team of medical writers)
• Regulatory submissions
• Investigator meetings
• Clinical trial site monitoring services including site initiation, protocol and GCP training, routine monitoring and source data verification, close out visits
• Development of monitoring plans, source data verification checklists and subject status tracking
• Assistance with subject recruitment strategies
• Creation and maintenance of a Trial Master File (TMF) both electronically and in hard copy
• Medical monitoring and pharmacovigilance assistance, and reporting of AEs to ethics and regulatory bodies
• Reports to Sponsor, newsletters to sites
• Organisation, tracking and ongoing oversight of trial budgets