The application of Oracle Health Sciences InForm enables Siro to automate and streamline solutions for the global biopharma and medical devices companies in their clinical development process across therapeutic areas and phases. The project is an integrated life sciences solution that consists of all the tools required to efficiently conduct and manage electronic data capture (EDC)-based clinical trials. All said and done, one can conclude that EDC in Clinical Trials is an integral part of modern clinical trials and one can really hope for a brighter future for EDC systems.Singapore: Siro Clinpharm, a leading full service clinical research organization, has deployed one-of-the-biggest IT advancement projects in the Asia Pacific region, Oracle Health Sciences InForm. Similarly, we need more professionals in the field of Clinical Data Management and Clinical Trial Management Systems to manage EDCs. For example, we need more software developers and vendors to come up with innovative ideas for making EDC systems more user friendly and accurate. There are number of people required in specific fields to develop an EDC system as well as maintain it. Other advantages of EDC include saving up a huge space and unnecessary use of paper work, thus one can say that EDC systems are environmental friendly too!!Įlectronic Data Capture in Clinical Trials has opened up a number of employment opportunities for potential candidates as well. The trial sponsor thus monitors the progress of the trial in a smooth way and can make sure that there were no deviations from the protocol during the conduct of the study. The EDC also immediately prompts for existing errors which can be rectified immediately. The data, when entered in the EDC can be checked prior to saving it, finally thus minimizing errors right away. EDC systems, through their user friendly and systematic approach tend to minimize these errors to a minimum, thus ensuring a faster mode of submission to the regulatory authorities. All this could lead to a major delay in getting approval for marketing of the drug and to reach the much needy patient. Now imagine the Paper Based Method of capturing this data and the number of errors which may occur during the process, infinite right? And to top this, these errors which are generated takes ages to be detected in the paper based system. Additionally, this data needs to copied multiple times too. We all know that a bulk of data needs to be submitted to federal agencies for drug approval. ![]() The first and foremost being error minimization. This makes us think, why use Electronic Data Capture in clinical trials at all? Well, this system has a number of advantages. Most companies these days are spending significant amount of cost and man power to manage clinical trial activities as database building, monitoring and management of data using a variety of EDC systems as Inform, Rave, Oracle Clinical Remote Data Capture, Veracity etc. Next comes the Validation component to check the user data for any obvious errors, and finally comes the reporting tool for data analysis. This is the screen that the end user sees on his/her computer. This Interface is mainly used for data entry. The first being the Graphical User Interface. ![]() ![]() So how does an Electronic Data Capture work in human trials? Well, we need to know of the basic three components on an EDC. This system replaces the traditionally used paper based system. ![]() So what basically is an EDC? It is a computerized system which is specifically designed to collect data during clinical trials in an electronic format. Ever wondered how the data that is generated during a clinical trial is captured? The system used by most pharmaceuticals and CROs these days is called as an Electronic Data Capture or EDC as we know it.
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