"DocBanq streamlines the management of regional and local monitoring services and makes it a lot easier and more efficient for multiple users to access documents securely."
Dr Lyn Tozer, Medical Director
 

Summary

Datapharm Australia Pty Ltd is a Contract Research Organisation (CRO), providing a one-stop-shop for clinical trials services to the pharmaceutical and biotech industries.  Established in 1987, Datapharm Australia has been regularly selected as the CRO of choice for the conduct of clinical trials in Australia by big pharma and small start-up biotechnology companies, and for data management and statistical analysis for overseas companies.  Datapharm Australia has a large client base and has provided services for research in Australia, New Zealand, China, United States and Europe.

The Challenge

The introduction of any new pharmaceutical product involves many years of closely monitored clinical research and trials that often occur simultaneously around Australia and in many other parts of the world.Accurate and comprehensive documentation and record-keeping is crucial to ensure that clinical trials meet their aims and are conducted safely.  The ultimate intention is to exceed the burden of proof required for achieving regulatory approval.

The speed at which regulatory approval can be achieved can have a large impact on the profitability of a new pharmaceutical product or medical device due to a fixed horizon for the intellectual property rights.  Therefore increasing the efficiency, speed and lowering the costs of conducting clinical trials is a constant goal of CROs.

Because the sponsor, the CRO and the trial sites are often globally distributed, managing trial documentation such as standard operating procedures, protocols, forms, visit reports and HREC documents effectively and securely can be time-consuming and relatively slow, given modern-day expectation of instantaneous communication of ideas.

The Solution

By using DocBanq, Datapharm Australia is able to offer its clients a secure clinical trial documentation environment that allows collaboration between the sponsors, the CRO and the trial sites.

In addition, Datapharm Australia is able to pre-populate trial-specific DocBanq environments with documentation modules (standard documents, templates and procedures) that encapsulate Datapharm Australia's know-how in this field.

Using DocBanq allows Datapharm Australia to reduce the risk of storing sensitive data on outlying computers and offers the possibility to tailor access to the documentation by participants.  The whole process is tracked via an audit trail.  "DocBanq streamlines the management of regional and local monitoring services and makes it a lot easier and more efficient for multiple users to access documents securely," said Dr Lyn Tozer, Medical Director, Datapharm Australia.

The Results

Docbanq allows Datapharm Australia to offer a distinct competitive advantage to clients that require clinical trial services by providing access to a powerful collaborative document management environment securely accessible from anywhere in the world - Datapharm Australia calls this application 'effice'.