One “WebSite” for Entire Study™:
Comprehensive, real-time, multi site and study level management through one centralized website.
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Enhances productivity and management study oversight while reducing study time and costs.
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Extensible System:
A CTMS designed and developed with flexibility and scalability allowing quick customization.
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A tailored solution that fully meets clients study management needs without having to pay for building it from scratch.
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Stable, Leading-edge Software Technologies:
Such as Microsoft .net technologies, SQL Server 2005, Service-Oriented Architecture (SOA) etc.
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Transfers up-to-date software benefits in performance, security, and stabilization, as well as lowers client’s cost of ownership.
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Easy-to-Use:
A simple, user-friendly interface designed for users with basic web experiences such as Yahoo Email.
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Reduces staff “down-time” by enabling new users to quickly go through training to use the system.
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Regulatory Compliance:
Compliant with HIPAA and 21CFR Part 11.
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Software enhanced compliance to meet sponsor’s regulatory requirements.
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Built-in Scheduling and Randomization:
One-time setup of protocol automatically randomizes patients and planned patient visits according to protocol at time of study enrollment.
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Reduces time and resources consumed in patient enrollment.
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Protocol and Resource Tracking:
Automatically validate protocol compliance and resource availability during scheduling study visits.
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Reduces time consumed in the scheduling process while increasing accuracy.
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Color-coded Visit Status and Tickler:
Track status of study visits in calendar; views in study, patient, or site level; generates alerts to relative users before and after the scheduled visits.
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Improves productivity by providing unique tools for different users (CRC, CRA, nurses, etc.) to track the visit status for different objectives.
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Configurable Study Site Milestones:
Track study progress and site productivity in real time.
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Improves productivity and management oversight functions while reducing study time and costs.
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Role-based Security:
Grant users’ access rights in both system and study level through system and study role.
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Enhances security by allowing different users to work on different tasks in different studies.
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Recruitment Tracking:
Track recruitment progress, results, and efficiency based on milestone.
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Improves recruitment efficiency through enhanced recruitment data analysis.
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Candidate Tracking:
Track candidate status history from recruitment and enrollment to completing or droping study.
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Increases accuracy and value of your candidate database.
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Outreach Activity Management:
Manage recruitment outreach activities and events with color-coded calendar and ticklers.
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Improved productivity and results in recruitment.
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Study Budgeting and Financial Tracking:
Set up study budget by visit and procedure level then track actual study costs and revenues along with study progress.
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Enhances management financial oversight.
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Incoming and Outgoing Checks Reconciliation:
Track study payables and receivables along with study progress.
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Improved productivity in billing and payment. Enhances collections capabilities.
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Securely-Managed Regulatory Documents:
Upload and download regulatory documents in a centralized location; manage and audit users’ access to documents based on study security setup.
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Improves security and centralized version control for regulatory documents.
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Regulatory Package Interaction:
Enter and track interactions to the regulatory document package.
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Improved productivity in IRB and submission.
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Real-time Data Reporting:
Query tools for users to view and print study management data in real-time.
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Enhances management study oversight and improves data value.
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Extensible Reporting:
Built on Microsoft SQL Server Reporting Services which support users to build, deploy and manage custom reports with easy-to-use and low-cost tools.
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Enhances management study oversight and reduces custom reporting costs.
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Report Exporting:
Built-in functions to export report data to Word, Excel, PDF, XML, or HTML format.
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Improves productivity and reduces redundancy by integrating data with 3rd part systems.
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