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Interactive Voice/Web Response System

By providing automated logistics management, drug supply savings and real-time project information, Interactive Voice/Web Response systems provide a sophisticated method of optimizing and managing the clinical drug supply chain.

Bilcare GCS' Interactive Voice/Web Response system is fully customizable and flexible to ensure that all your clinical trial needs are met without interruptions. Bilcare GCS' Interactive Voice/Web Response system is 21 CFR Part 11 compliant and ensures data integrity, acceleration of clinical site initiations and provision of real-time patient, site and study metrics via an interactive website.

Services

  • Customized Interactive Voice and Web Response System programming.
  • Patient enrolment and randomization.
  • Patient diaries.
  • Site administration and tracking.
  • Secure web-enabled reports.
  • Clinical supply management including automated supply and re-supply, site and depot inventories, individual kit status and activation notification, and expiry management.
  • Real-time reporting and tracking via web.
  • Outbound fax and emails.
  • Technical support and training for staff and investigators.
  • Adaptive trials.
  • Predictive inventory.
  • Supports multilingual voice recordings in an unlimited number of languages.
  • Can be integrated with any of customized program.

21 CFR Part 11 Compliance

Our Interactive Voice/Web Response applications and systems operate in compliance with 21 CFR Part 11 and FDA requirements, especially pertaining to systems validation, systems security, data integrity, audit trails and encryption.

Reporting Application

A web-accessible reporting application offers authorized users timely access to the latest and most accurate study information. The system provides a standard reporting package. Authorized users can also create and prepare custom reports that can be delivered via web, fax, email or telephone.

Primary & Secondary
Packaging

Testing, Validation and Training

Each study-specific Interactive Voice/ Web Response implementation is tested and validated to meet compliance requirements for FDA regulations. Documentation for each study is maintained on-site in the documentation library for review and audit. A test system is available for user and site investigator training throughout the life of the study.