Web-based Centralized site recruiting and monitoring solution: The Web Tracking System

The Web Tracking System (WTS) coordinates the activities of all site support staff from one or many monitoring organizations. The backbone of multi-discipline clinical trial communications, WTS helps build a database of qualified sites, manages regulatory document workflow and the performance of sites, records investigator meeting attendance, generates investigator payments based on achieved milestones and helps monitor. In addition, the WTS can allow monitors worldwide to access and submit site and subject specific data directly into a central database.

The Perceptive Solution

The WTS complements much of the functionality of a Clinical Trials Management System such as IMPACT™ by adding operational, transaction-based functionality, supporting a call center environment.
The WTS provides functionality to assist with:

Site Recruitment and Qualification
Manage recruitment and qualification communication with thousands of sites at a time. Produce regulatory package mailings, and trigger and tracking clinical supplies processing.

Regulatory Document Collection and Tracking
Once sites are qualified, a workflow can be set up allowing detailed tracking of regulatory documents and site packages through the regulatory process.

Meeting Management
Track site enrollment and attendance at investigator meetings.

Site Management
Facilitate and track routine monitoring calls, providing monitors/CRAs with critical site data (CRFs, queries, patients, payments, etc.), as well as tracking and facilitating the site closeout process.

Exhibit 1
WTS workflow enables seamless management of study activities.

Features

Call-Center Workflow Tool

• WTS helps track telephone and fax communications to hundreds, up to tens of thousands, of potential sites. The workflow engine distributes tasks to call center, Regulatory and CRAs that enable a supervisor to assign and track the flow of work within the operation.
• Search criteria covering site, center, investigator, location and status.
• WTS helps the call center expedite the production of regulatory package mailings, study-in-the-box mailings (site acceptance kits), and clinical supplies processing.

Secure, Web-based User Access With Role-based Views and Capabilities

System functions can be grouped into roles as needed for each trial.
Role based security, user's role determines functional access and information displayed.

Configurable Interface to Reflect Sponsor Name, Logo, and Hyperlinks to Trial Documentation
WTS uses HTML cascading style sheets which enables the color scheme to be configured for trial specific needs.

Wide Range of Regulatory Documents Recorded and Controlled Against the Regulatory Process
Regulatory document tracking and approval workflow are 100% configurable to meet trial specific needs.

Communications with External Sources
Inbound interfaces include:

• Patient data from external IVRS system
• Clinical data (CRFs and queries) from external data management system

Outbound communication includes:

• Perceptive Portal™ displays key metrics and configurable reports
  
  Audit Trail of changes of data
  Every addition, update, or deletion is tracked in the WTS audit trail, for every field in every table.

Benefits

• Rapid study start-up – even when dealing with thousands of investigative sites.
• A single consistent easy to use interface for all users can improve the quality and timeliness of the data entered.
• Workflow engine facilitates central monitoring by a call center and CRAs and can speed timely, correct completion of study activities.
• Short learning curve for field staff can reduce costs of start up – both in time and travel.
• Workflow automation of Regulatory, investigator payments and site communications can shorten study cycle time.