Datapharm Australia Pty. Ltd.

Datapharm Australia Pty Ltd is a CRO (Contract Research Organisation) and DMO (Data Management Organisation) that was established in Australia in 1987.

Our clients include local and overseas pharmaceutical and biotechnology companies conducting clinical research. Our professional and experienced team of over 30, includes statisticians, programmers, pharmacy, medical, nursing, engineering and science graduates as well as data managers, psychologist and project managers.

With regional capacity in each state of Australia we are also proactive in establishing associations with overseas CROs. This has increased our access to global projects and allowed local biotechnology companies to sponsor projects overseas using our services. Current working associations allow us to monitor studies in United States (ongoing study) and Canada, Europe (as part of the AXIS network of 20 CROs), China, Singapore and New Zealand. We have also successfully provided training in Japanese for clinical research coordinators from Japan.

Our niche expertise is clinical data management including development of applications for remote data capture and use of systems for entry and statistical analysis compliant with FDA standards.

Datapharm has a flexible but professional team approach to each project with an emphasis on understanding the science, maintaining friendly communications, and providing quality services with an overlay of efficient project management skills.

Mission Statement

Datapharm Australia Pty Ltd is to maintain a culture and expertise to provide quality contract research services to the pharmaceutical and biotechnology industries in an efficient and timely manner.

Datapharm Australia Pty Ltd culture is sponsored by a passion for working intelligently, efficiently and flexibly with and in support of clients for ultimate project success.

Datapharm Australia Pty Ltd expertise relies on well trained, qualified and experienced staff with strong communication skills, a high level of accuracy and an interest in clinical research methods and therapeutics.

Personnel Mission Statement

• To have a passion for working intelligently, efficiently and flexibly together.
• To support clients as if Datapharm Australia Pty Ltd is an extension of the client's organisation.
• To actively inform the client of all project matters to minimise the client's project management time input.
• To be vigilant in maintaining client confidentiality agreements and security.

• Clinical research services including
  • Clinical Trial Design
  • Investigator Selection and Start-up meetings
  • Protocol Development
  • Ethics submissions
  • Case Report Form Design
  • Monitoring - Regional around Australia and overseas (China, US, Europe - AXIS network)
  • Tracking
  • Pharmacovigilance
• Data management
  • Database set-up
  • Data capture
    • double data entry
    • scan/fax
    • remote data entry (web-based and offline)
    • Japanese/Chinese
  • Data validation
  • Coding (MedDRA, WHO, Costart)
• Statistical services
  • Sample size calculations
  • Randomisation
  • Statistical analysis plan
  • Statistical analysis
• Report writing
  • Full study report
  • Publications
• Project management
  • Project Advantage™
• Training
  • Study Co-ordinator Courses
  • Australia/Chinese/Japanese courses
• Audits
• Contract Staff Available
  • CRAs
  • Data managers
  • Encoders
• Health economics
  • Literature searches (PBAC, MSAC)
  • QOL data capture and analysis
• Software applications
  • E-Archive
  • Hypernet
  • E-CRF
  • SMART (Smooth Monitoring A Resource Tool)
  • RSR (Remote Safety Monitoring)
  • Company specific tracking systems

Datapharm Australia has pleasant offices in Drummoyne, a suburb of Sydney which is centrally located 15 minutes from the CBD and from northern and western pharmaceutical and technical hubs. Staff can enjoy the relaxed environment of a leafy courtyard for lunches and training sessions and meetings are held in an adjacent meeting room. The offices are protected by security systems and have underfloor wiring for safe and secure transmission of data.

In each state Datapharm has regional monitors who are based in home offices and provide local services for monitoring studies in each state, saving clients the cost of interstate travel. Our Sydney based monitors also travel interstate regularly and are available for monitoring New Zealand and Singapore.

Datapharm is able to select investigators around Australia and in addition has an association with a clinical trials centre based in Sydney. This unit has the capacity to run studies in all phases including Phase 1 studies and pharmacokinetic studies involving overnight stays.

Datapharm also manages projects overseas and provides country-based CRAs to monitor projects in overseas countries eg United States, Canada, China, Singapore, Europe, New Zealand.

The advantages of choosing Datapharm Australia to contract your clinical research and data management are:

• Our team has 15 years of experience and management in clinical research with very low staff turnover.
• A flexible friendly approach allows for CRO and sponsor to work as a team combining experience and management skills ensuring ultimate project success.
• Site and sponsor experience is high - Datapharm has worked with over 50 pharmaceutical companies on over 250 projects.
• Team has worked successfully in over 35 therapeutic areas.
• All phases (I to IV) and types of studies are performed.
• Our productivity is high %A1V 20 to 40 studies ongoing each month.
• We have access to an Australia-wide base of qualified investigators - feasibility for new studies done on a regular basis.
• There is access to an Australian trials centre with capability for Phase 1 and bioavailability studies with subjects having overnight stay with full access to hospital facilities.
• Ethics submissions are prepared regularly (eg 40 in 2 month period) with high success rate. Clinical Trials Notification (CTN) in Australia means that there is no long wait for regulatory approval once EC approval is gained.
• Our comprehensive service allows for smooth drug development from protocol development, trial set up and monitoring through the data management phase to the final study report and publication.
• Efficient systems (Project Advantage™ ) are set up for each project allowing ongoing status of actual work done vs budgeted and actual expenditure. This project management facility is possible with collection of excellent project metrics over the years.
• Our SMART (Smooth Monitoring A Resource Tool) application allows for prediction and tracking of monitoring resources.
• Clinical site budgets can be organised, monitored, paid and tracked.
• Datapharm works to international (ICH, FDA) and local country-specific standards allowing data sets and reports suitable for submission around the world.
• We enjoy keeping up with technology - remote data capture, tracking systems, audit trail, electronic signatures, and firewalls are an integral part of our business.
• Datapharm Australia's SOPs have been audited on many occasions - last data systems auditor noted "Congratulations! no action required!"
• Cost-efficient - no on costs entailed in business development and marketing of large global CROs.
• Australian dollar should be considered as a cost effective currency for international research projects.
• High quality trainers and auditors are available.
• Time-zone compatibility with other Asian countries is an advantage for studies run in this region.
• Established global links with Asia, US, Europe allow for seamless monitoring and data collection for overseas study sites.

Contact Information

Datapharm Australia Pty. Ltd.
Helen Allars, Managing Director
56/56A Thompson St
Drummoyne, New South Wales 2046 Australia
Phone: 612-9719-2800
Fax: 612-9719-2811
E-mail:

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