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Products : HPR : CDS : Electronic Data Capture
Electronic Data Capture
As the costs of clinical studies rise, and the demand to quickly deliver therapies to market intensifies, renewed emphasis is placed on technology solutions such as Electronic Data Capture (EDC) to control operational costs and expedite time-to-market. By capturing data electronically, and storing the data in advanced databases, key clinical constituents — investigators, sponsors, research organizations and regulatory agencies — can gain access and visibility into study data sooner for earlier insight into the conduct of studies. In turn, earlier insights enable study decisions to be made in a timely manner during the clinical development cycle.
Advanced EDC technology incorporates streamlined study design, workflow, discrepancy management, coding, integration standards, regulatory compliance, and extensive reporting and analysis into the overall solution. MedChannels' OrderPro™ Integrated Trial Management (ITM) system delivers all of this functionality in an award-winning EDC solution that has already been used successfully in over 40 trials*.
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EDC Solution: OrderPro™
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Advanced Electronic Data Capture (EDC) technology incorporates streamlined study design, workflow, discrepancy management, coding, integration standards, regulatory compliance, and extensive reporting and analysis into the overall solutionUsing the OrderPro ITM product’s intuitive interface, clinical research coordinators, trial monitors, clinical data managers and project managers can work more efficiently and with greater accuracy. The OrderPro ITM advanced reporting and analysis tools are designed to enable sponsors to view and act on data earlier in the trial development cycle and manage study procedures and expenditures more effectively. Leveraging the OrderPro ITM product’s proven track record for scalability and ease-of-use, organizations can rest assured that when conducting trials of any type or size this flexible EDC solution will accommodate their global requirements.
· Streamlined trial design and set up
· Intuitive, workflow-based Graphical User Interface
· Extensive query management processing features
· Full support to enable compliance with GCP, 21 CFR Part 11 and other regulatory guidance
· Support for CDISC integration standards
· Fully integrated, real-time trial management reporting and analysis
· Extensive library of configurable standard reports and ad hoc reporting
· Extended modules for clinical coding, offline capture and management, and PDF archive and submission
· Scalable Internet-based architecture is designed to support trials of all types and sizes, and accommodates regional as well as global populations
· Integrated with MedChannels' Central Coding for OrderPro™ product, market-leading SafetyNET™ safety solution, and TrialPro™ clinical data management system
· Available as a hosted solution for rapid deployment or enterprise adoption option for in-house operation
· Global 24x7 multilingual support.
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