“The ever increasing computerisation of the worldwide healthcare system will mean a practically paperless environment when study protocols will specify what data points at which intervals need to be transmitted from the clinic to the company headquarters via electronic means.” Richard K. Rondel, Sheila A. Varley, Colin F. Webb: Clinical Data Management, 2nd Edition, 2000.
To achieve same level of competitiveness and attractiveness as offered by other data management centres Accelsiors has successfully implemented a technology leader Remote Data Capture (RDC) system, the Oracle’s RDC 4.6.
This is a robust, highly validated, well-known and one of the most reliable systems in pharmaceutical industry.
RDC eliminates the need for data transcription from paper CRFs since information is entered on-site and transferred to a central database via internet. The system facilitates accurate data capture by applying edit checks immediately at data entry, and therefore decreases query rates, reduces timelines and supports expeditious data lock and analysis.
The screens in RDC appear exactly as electronic versions of paper CRFs, which makes them very easy for use by Investigators and site personnel used to work with paper CRFs.
RDC not only gives us real time data entry and cleaning but also the ability to view accruing data on a real-time basis, affecting many aspects of the clinical trial process. The most significant enhancements give Project Management the ability to browse current data and generate ad hoc tabulations and data summaries, providing a faster, more nimble approach to managing many operational aspects of a clinical trial on a more real-time basis. The reality RDC brings is constant data access and real-time metrics that not only reduce the probability of surprises at the end of the trial but allows for more informed decisions to be made sooner.
Oracle RDC is integrated with Oracle Clinical and is therefore capable of providing hybrid system design, that is, allowing usage of both paper CRFs and RDC within one single study.
Additionally, Oracle RDC can generate submission-ready patient CRFs directly from the system with its Patient Data Report tool. This simplifies electronic submissions to regulatory agencies and also allows reviewing patient data by inspectors or auditors without granting them direct access to the live system.
Oracle’s RDC 4.6 is the best choice for good study set-up, efficient data capture and quick data reporting.
