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SmartStudy™ Overview
Site CTMS
CRO/Sponsor - Site Integration
Features and Benefits
Technologies



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Find out how SmartStudy™ can be quickly implemented to fit your unique environment and address your most immediate clinical trials challenges.

SmartStudy™ Features and Benefits

Features Benefits
One “WebSite” for Entire Study™:
Comprehensive, integrated, and real-time study management through one true web system.
Enhances productivity and management study oversight while connecting and centralizing management of the distributed studies.
Extensible System:
A CTMS designed and developed with flexibility and scalability allowing quick customization.
A tailored solution that fully meets clients study management needs without having to pay for building it from scratch.
Stable, Leading-edge Software Technologies:
Such as Microsoft .net technologies, SQL Server 2005, Service-Oriented Architecture (SOA) etc.
Transfers up-to-date software benefits in performance, security, and stabilization, as well as lowers client’s cost of ownership.
Easy-to-Use:
A simple, user-friendly interface designed for users with basic web experiences such as Yahoo Email.
Reduces staff “down-time” by enabling new users to quickly go through training to use the system.
Role-based Security:
Grant users’ access rights in both system and study level through system and study role.
Enhances regulatory compliance include HIPAA and 21CFR Part 11.
System Setup Module:
Configures the system Application and Administration functions. One unique application feature that assists users in setting up studies is Procedure Lists &Templates that enables users to quickly add standard procedures to a visit as well as pricing to budgets.
Improves staff productivity and accuracy in both study and budget setups.
Study (Management) Module:
One-time setup of study protocol automatically randomizes patients and planned patient visits at time of enrollment; Provides unique views and tools for different users (CRC, CRA, nurses, etc.) to track the status of study patients, visits, and sit progress in real time.
Improves productivity and management oversight functions while enhancing study protocol compliance.
Recruitment Module:
Manage recruitment outreach activities and track recruitment progress, results, and efficiency based on milestone; Track candidate status history from recruitment and enrollment to completing or dropping study.
Improves recruitment efficiency through enhanced recruitment data analysis; Increases accuracy and value of your candidate database.
Finance Module:
Set up study budget by visit and procedure level then track actual study costs and revenues along with study progress; reconciles incoming and outgoing checks.
Enhances management financial oversight; enhances collections capabilities.
Document (Management) Module:
Upload and download regulatory documents in a centralized location; manage and audit users’ access to documents based on study security setup; Enter and track interactions to the regulatory document package.
Improves security and centralized version control for regulatory documents; Improves productivity in IRB and submission.
Reports Module:
Built-in reports and query tools allow users to view and print study management data in real-time and export report data to Word, Excel, PDF, XML, or HTML format.
Enhances management study oversight and improves data value; Reduces costs in custom reporting and data interchange with 3rd part systems.
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