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Datapharm Australia

June 24, 2013

Local CROs Unite for International Clinical Trials

Global CROs are no longer the obvious choice for companies looking to run international clinical trials. The motion is towards...
pharmacuetical business review


Datapharm Australia

Datapharm Australia is an AusIndustry Research Service Provider (RSP), who has for 25 years has provided full in-house CRO services. Our experienced, high-quality personnel have long experience in observation and involvement in clinical study processes.

Delivery of services to the standard required by the industry and its regulators

datapharmDatapharm Australia’s clients include big pharma, biotechnology, and device companies and these extend internationally. We have audited CROs in Philippines, Korea, and India with collaborations in North & South America which enable us to manage trials with sites outside Australia at very competitive costs.

datapharmDatapharm Australia’s quality in clinical studies ensures the delivery of services to the standard required by the Industry and its Regulators. Quality risk identification and management is crucial in the planning stage of any study. All parties in a project team need to be involved in that analysis. Monitoring then, of all operations, becomes more focused and effective to meet the quality objectives.

Hundreds of clinical studies in over 35 therapeutic areas

datapharmDatapharm Australia is a full service in-house CRO with many of the original personnel now supported by highly qualified and respected scientists and technicians. The range of scientific and medical backgrounds of the Datapharm team coupled with the network of specialist colleagues offers strong foundations to any project. Datapharm has carried out hundreds of clinical studies in over 35 therapeutic areas during the last 25 years.

Project AdvantageTM management processes

datapharmDatapharm Australia is the leading Contract Research Organization (CRO) team providing experienced, high-quality clinical support services Australia wide. Client partnerships and relationships are important to us and are achieved by active rather than passive feedback and communications, as promoted in our Project Advantage TM management processes.


A Datapharm initiative to reduce all concerns of the client during the project by ACTIVELY COMMUNICATING all necessary information on PROJECT STATUS as determined and offered at the start of the project and found helpful during its delivery, such as:

  • PSI (PROJECT STATUS INVOICING) gives %completion vs %$spent against the budget including relevant comments
  • Other requested periodic details; patient recruitment etc
  • We have PROJECT METRICS OF MANY CTs enabling us to give ACCURATE project estimates
  • More sophisticated contracts derived from the engineering construction industry, incorporating

Seven Reasons Why Datapharm Australia

  1. 25 Years experience in all aspects of clinical trials in most therapeuticareas
  2. Engineer designed management – Active support to the client with our "PROJECT ADVANTAGE" systems
  3. Practical science focused
  4. "Project comes first" culture
  5. Know the most appropriate investigators and sites
  6. Highly qualified personnel
  7. International experience on larger trials

Latest Datapharm Videos!

Adam Rogers (Swanson Reed) & Luke Edington (Datapharm CRO) discuss the R&D Tax Incentive for the Australian Clinical Trials Series. To view the video please click the Link: Australian Clinical Trials Series: R&D Tax Incentive (Episode 1)

To view Datapharm’s latest video on EDC Software Evaluation, please click the link: EDC Software Evaluation – Clinical Trial Tech Series (Ep1) Datapharm Australia CRO


Datapharm Australia
56-56A Thompson Street
NSW 2047
Phone: + 61-2-9719 2800
Fax: + 61-2-9719 2811

Clinical Trial Design Monitoring Services

Datapharm Australia's expert data management team with experience across a wide range of therapeutic areas and high level of attention to detail will custom-design your paper-based case report form (CRF) or electronic data capture (EDC) or ePRO systems to suit your trial, protocol and budget.

Case report form designOur CRF forms or system are efficient and cost-effective to build and the use of well-established library templates which have been refined over many years to create a high quality easy-to-complete CRF. More importantly, our CRF design is compliant with ICH GCP and CDISC/CDASH standards to facilitate data capture and statistical reporting…

Clinical Trial Design

We can design clinical trials for any number of subjects. Our clinical trial management, data management, statistics and medical/pharmacovigilance teams work in close collaboration to ensure all aspects of your trial will be considered in the design phase.

We can build any trial design, including:Open labelBlinded (single or double)RandomisedParallel groupsCrossoverPlacebo-controlled and/or comparatorRetrospectiveAdaptiveWe can design the trial to evaluate any outcome you are looking for, for example:EfficacySafetyPharmacokineticPharmacodynamicHealth economic

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…

Clinical Trial Monitoring Services

Datapharm Australia's clinical trial monitoring services have always been fundamental to our operations. Our extensive national and international experience over a wide range of therapeutic areas has brought Datapharm well deserved respect and admiration for the standard of monitoring services offered.

Our Monitors undergo extensive ongoing training both internally and externally, and have a thorough knowledge of ICH GCP, local regulatory requirements and current industry best practices. We have deep experience in the full spectrum of clinical trials from Phase 1 (first in humans) to Phase IV (post-marketing surveillance) according to ICH GCP principles and local…

Data Management Services

Specialists in data management since 1987, our high level of attention to detail combined with our well developed procedures and common-sense approach across various clinical trials over multiple countries, have earned Datapharm Australia a strong reputation for providing excellence in all data management processes.

Experience, Expertise, Performance in Data Management Services in Clinical TrialsAs information management specialists, we can meet all your data management needs and are able to tailor our services to meet your budget.Our data management specialists are highly experienced in handling medical and scientific data. All data is thoroughly reviewed by appropriately trained and experienced staff…

Medical and Scientific Writing

Our experienced team of Medical Writers come from diverse backgrounds offering a wide range of expertise. All have PhD's or MBBS and are experienced in preparing manuscripts for scientific, medical, regulatory and lay audiences.

A team of specialist medical and scientific writers meeting appropriate regulations and guidelines in:Clinical study protocols (including study design) Investigator Brochures Clinical Study Reports Ethics documents, Patient Information formsProduct Information documentsMarketing presentationsSafety reports and event narrativesScientific documents to journal specifications and guidelinesCopy for general health publications (books, magazines)Medical and scientific editing (including proof reading) 

Medical Monitoring and Pharmacovigilance

Our medically qualified personnel are able to offer a wide range of medical monitoring and pharmacovigilance services to support your product development.

Respond to trial site queries about eligibility issues or other medical or safety issues arising at the outset and during clinical trialsLiaise with and report to DSMB Receive and process SAE forms for clinical trialsReport to regulatory authorities as required (TGA, FDA and EMA)Prepare adverse event and serious adverse event narratives, with follow-up until resolutionClinical…

Quality Control Processes and Auditing

Internal quality management (QM) consists of:Regular internal GCP audits of clinical trials and processes Staff training in all aspects of GCP Writing and reviewing SOPs and work manuals Tracking staff training in all internal procedures Providing advice to staff in quality aspects of clinical trials Reviewing reports, plans, protocols and other documents written by staff…

Statistics Services for Clinical Trials

Datapharm Australia's highly trained statisticians are experts in producing high quality data analyses and reporting for clinical trials. With 25 years of applied clinical trials experience, no statistical problem is too complex for our team.

As part of a full service contract research organization, our statisticians work seamlessly with Datapharm trial monitors, data managers and medical writers to produce high quality statistical analyses and reporting.Our statistics services include:Clinical Trial DesignDatapharm statisticians have designed many clinical trials. From small early phase studies to multicentre late phase trials, our statisticians are experts…
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