Prospective Research / Patient Surveys

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Patient/Family and Clinical Treatment Survey System (PACTS) provides an easy-to-setup and manage and easy-to-use web-based survey tool designed to capture patient/caregiver self-rated surveys/scales as well as clinician rated surveys/scales.

The PACTS system consists of three main modules. The survey system a user friendly web based application with branching, and validation logic. The administrative module used to enter new clients, initiate visits, view historical clinical data and reports. The third module is the management software application called clinical coordinator. The clinical coordinator includes tools for end user to create/modify surveys, with branching logic and validation rules. In addition the clinical coordinator manages all study setup including, visit schedules and security.


Clinical Features
  • Web-enabled universal access system
  • Easy-to-use point-and-click model of entering survey data.
  • Supports clinician workflows, interview style CRFs, and patient/family administered measures.
  • User friendly graphical user interface (GUI)
  • Configurable with XML style sheet - fonts, colors, and formatting
  • Sophisticated Branching/Skip Logic – navigation of surveys based on client response
  • Response Checking/Validation – configurable validation checks (i.e., dates, range checks, etc.)
  • Embedded Web Links - allows users to access select internet sites
  • Data Protection Save-as-you-go ensures data is never lost even in network failures
  • Easy to administer: Patient self-administered passwords reduces administrative costs
  • Email reminders with embedded passwords for end user
  • Provides Support Audio files: questions can be “read” to users
Regulatory Compliance
  • Enables customers to deploy PACTS as part of a validated system compliant with GCP predicate rule requirements, laws and regulations applicable to the conduct of clinical trials, and FDA 21 CFR 11 pertaining to the use of electronic records.
  • Complete audit trails with delta change history on each and every data element entered
  • Online and offline data entry
Study Management
  • Dynamic Surveys – clients can create, update, modify without programming
  • Preconfigured library of CRF’s available for use
  • Facilitates quick response to protocol amendments and redeploys revised study protocol
  • Accelerates interim analyses through a simple transfer of data into SAS
  • Enforces protocol design at the visit level to ensure all data is captured
  • Multi-Site Support – Survey system supports multiple sites keeping each site’s data separate
  • Provides real time data access reports with the capability of configuring custom reports.
Technical Features
  • Scalable 3-tier architecture with web/business/data layers that can reside on the same computer or on independent servers for increased scalability
  • Import function simultaneously creates survey questions and data base schema
  • Easy-to-deploy open architecture allows standard low cost technical setup
  • Creates ability for on-going data monitoring and clean-up throughout the study
  • Provides ability to transfer data at any time and lock the database
Benefits
  • Rapid Study set-up and start-up
  • Low cost for deployment and maintenance
  • Enables customer to be regulatory compliant
  • Flexible system easily accommodates protocol revisions
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