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Clinical Trial Data Management

Managing clinical trial data or even the change management process associated with large clinical trials can be managed with this ExtraView solution. In a validated environment, your process may be followed precisely, with a full audit trail and with complete security. Full notification to all interested parties of all key events ensures quick follow up. Search for anomalies and patterns in your data and use triggers to provide the automatic escalation of events out-of-specification.

ExtraView has been implemented successfully by the following types of research organizations

  • Biotechnology
  • Medical Device
  • Pharmaceutical
  • Contract Research Organizations (CRO's)
  • Academic Institutions

Key Features

  • Web-based - Standard web browser access with no client software to install. Unlimited number of role-based layouts, views, queries and options
  • Point-and-click Configuration - Multiple forms or departmental business areas within a single database. Add an unlimited number of custom fields and an unlimited number of user roles
  • Workflow Management - Allows subject enrollment, data submission and validation for use by clinicians and research associates as well as Query Management and Bulk Data Import. Workflow may be defined for each role, form and project. Rule workflow administration allow for validation of data and processes
  • Reporting – Create and save public or personal reports. Report types include: Column reports, Summary reports, Matrix reports, Dashboard reports, Aging reports, Container reports, Planning reports and Custom reports. Reports may also be converted into Microsoft Word, Microsoft Excel or PDF formats
  • Audit Trails – Changes to any field on a form are part of a full, visible audit trail. Each change is time stamped and annotated with the name of the person. All changes to the underlying system metadata as well as all user access are also recorded in an audit trail
  • Electronic Signatures - Configure electronic signatures on any criteria, to provide reauthentication at the time of update, conforming with regulations such as 21 CFR Part 11 and 21 CFR Part 820
  • Notifications - Automatic and rule based notifications upon record updates. Alerts and update can be sent and received through email. Reports can be scheduled and sent by email on a periodic basis
  • Security - All fields are controlled with field-level security permissions for each role: read/write access, read-only access, no access. All key data collection functions are protected by a role-based security key. Definable password policies and expiration procedures. Electronic signatures may be defined for any step in the workflow. There is extensive control over all the application to prevent unauthorized usage
  • Extract Data - Enables data extraction and filtering of datasets for use by investigators and principal investigators
  • Study Build - Facilitates creation and management of studies (protocols), sites, CRF's, users and study event definitions by principal investigators and coordinators

Key Benefits

  • Consolidate clinical trial activities and information in a secure, closed-loop system via web access
  • Cut operational costs and improve resource workflow with automated procedures and rules
  • Monitor activities through online audits, inspections, checklists and questionnaires
  • Fast action for any violations or discrepancies through resolution
  • ExtraView is "validation-ready", so all you need to do is prove that it functions correctly in your environment. To assist with validation tasks, we provide full test scripts
  • Training - We provide complete "train-the-trainer" end-user training, designed to prepare your core users to train the rest of your users, and ExtraView administration training, designed to empower you to manage the administrative tasks that can be done through the user interface