Interactive Voice/Web
Response System

Overview Formulation Development Analytical & Research Services Clinical Manufacturing, Packaging and Labeling Interactive Voice/Web Response System Global Logistics and Supply Chain Management Depot Management QP Services Comparator Sourcing In-sourcing CTM Services

Case Study

Brochures & Publications

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

Bilcare GCS’ IVR/IWR system is fully customizable and flexible to ensure that all your clinical trial needs are met without interruptions. Bilcare GCS’ IVR/IWR 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 IVR/IWR 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

21 CFR Part 11 Compliance

Our IVR/IWR 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.

Testing, Validation and Training

Each study-specific IVRS/IWRS 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.