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TALK TO AN EXPERT
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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 or electronic case report form (CRF), or electronic data capture (EDC) to suit your trial, protocol and budget. Our CRF forms or systems 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 so that your trial data can be submitted to any regulatory agency. Datapharm Australia offers single, double data entry or scannable forms processing. Our data entry operators are fast, accurate, consistently achieving 99.98% accuracy. Our data capture prices are highly competitive. |
Take on a Few Leading Industry’s Electronic Data Captures
Electronic data capture system (EDC), via eCRF, can appreciably enhance data quality, facilitate data review, and ultimately, shorten the duration of the trial. Utilising CDISC , FDA 21 CFR part 11 recommended standards and following ICH GCP guidelines, Datapharm Australia can build a user friendly EDC database tailored to capture the data that your trial requires.
Datapharm Australia’s data management team has had years of experience and deployed multiple EDC platforms from various EDC providers. Depending on your study designs and budgets, an EDC platform that is catered to your trials’ needs will be proposed to you.
Among these EDC platforms, IBM Clinical Development (ICD) system has been widely used for most of our studies. Datapharm Australia has been in partnership with Merge Healthcare and later changed ownership to IBM since 2010. Our data management team is certified to set up, deploy and manage EDC studies in the ICD platform. ICD system can offer a wide range of tools such as interactive web response (IWR) or randomisation, trial supply management, data integration and migrator, access to electronic patient reported outcomes (ePRO) or electronic clinical outcome assessment (eCOA), medical coding, images upload, etc. to help manage different aspects of the trial.