Clinical Trial Management

Whether you need local or international project management of clinical trials Datapharm Australia can provide expertise in many therapeutic areas at all developmental phases of research in both drugs and devices.

Since 1987 Datapharm Australia’s experienced team has been involved in several hundred projects and is well known and respected for the excellence of clinical trial management for the pharmaceutical and biotechnology industries. We manage, monitor and present all clinical trials according to ICH GCP principles and regulatory requirements.

Our clients’ budgets are managed using Project Advantage and Project Status Invoicing which presents project phase by work category against estimated and actual time. As part of our service to you our project managers will work with timelines for data analysis to meet prearranged presentations to client boards or funding agencies.

Our clinical trial management services include:

  • Clinical trial design and preparation of clinical trial documents (protocol and investigator brochure)
  • Site feasibility, investigator selection, preparation of ethics submission documents and regulatory submissions and assistance with recruitment strategies
  • Investigator meetings, site monitoring services (initiation and close-out, site staff training, source data verification, essential documents), site newsletters
  • Development of tracking systems (ethics approvals, subject recruitment), monitoring checklists, site and pharmacy logs, Trial Master File (TMF)
  • Medical monitoring and pharmacovigilance services
  • Client meetings and regular reports, organisation, tracking and ongoing oversight of trial budgets (clients and sites)
  • Clinical data management with database setup, CRF design, data cleaning and coding
  • Full statistical analysis services and clinical study report writing