Industry Provider Profiles Company Type Services
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
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.
Helen Allarswww.datapharm.com.au/ View Map Contact Company
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