Technology-leading Voice Based System for Data Collection

Sophisticated voice systems are being used to collect data, randomize patients and manage study drug inventory. Today, approximately 30% of trials employ Interactive Voice Response Systems (IVRS) to manage these key functions. This percentage is projected to increase as voice systems continue to prove themselves by streamlining trial processes. Additionally, it is accepted that IVRS can help reduce wastage of clinical supplies by at least 5-20%. These percentages can be increased with the appropriate application of complex and predictive inventory management functionality.

The Perceptive Solution

Perceptive Voice™ comprises an overall service which uses a technology leading software product ALADDIN™ for patient randomization, study drug management and voice based systems for data collection. The service was set up in 1995.

Perceptive Voice has a comprehensive project and validation lifecycle that includes the management of all aspects of projects.
It includes:

• Project initiation, covering proposal and setup phases
• Design, covering requirements definition, technical meetings and sponsor approval
• Validation planning
• Development, to build and unit test the application
• Controlled testing, to incorporate execution of test scripts and user acceptance testing in a qualified test environment
• Implementation in the real environment
• Operations and ongoing support, including periodic assessments and reviews
• Retirement, whereby production is closed down, data is transferred to the sponsor and the study archived

An appointed Project Manager will work with the sponsor on all of the above stages. In particular they will help identify appropriate system requirements and study considerations. They will also identify key data and records at the beginning of the study and assist with proper archiving at system retirement. Operations support includes all aspects of IVRS management, site support, distributor management and ongoing system monitoring to ensure the system is functioning optimally through the entire life of the project.

The functionality covered by the service incorporates:

• Patient randomization
• Inventory management (for clinical supplies and medical devices)
• Clinical supplies forecasting
• Medication assignment
• Central code break
• Follow up visits
• Patient diary collection
• Automated call-out reminder system
• Site and patient shut-off
• Healthcare resource utilization
• Real-time reporting
  

Features

• Use of robust but flexible and scalable technology (ALADDIN ) allows for timely development of even highly complex protocols, sometimes in as little as 2 weeks
• Supply via application service provision (ASP) model, for trial by trial projects
• Supply alternatively, via technology transfer (license) model. ALADDIN is available for in-house usage and is currently being implemented or investigated at a number of top Pharma companies
• Project management team with extensive and relevant experience
• 24 x 7 x 365 multilingual support
• Investigator access can be via the web, fax, email or a traditional touch tone telephone
• Adaptive randomization
• Just-in-time and inventory projection tools, which tightly monitor project drug supply at the distributor and site by using predictive algorithms. These are based on actual study data (e.g. enrollment rates, withdrawal rates, visit schedules, etc.)
• Drug supply forecasting
• Integration (via standard interchange mechanisms) with other Perceptive and 3rd party products (including IMPACT™, drug supply management systems and clinical data management systems)
• Comprehensive disaster recovery infrastructure allows for immediate access in the event of an unplanned shutdown
• The Perceptive Voice application is always available and with no hardware/software demands of the site
• New and complicated protocols can be authored completely independently of any of those that currently exist

Benefits

• Cost control (less drug wastage with just in time inventory management and other features).
• Close management by sponsor of patient enrollment at sites, to prevent over-enrollment in trials.
• Efficient central randomization (including use of highly complex adaptive algorithms).
• Improved data accuracy and availability.
• Experienced project management teams promote successful IVRS from design through retirement.

Confidence when dealing with regulatory authorities. Our company focus on quality and regulatory compliance leads to a fully validated system with special attention to applicable regulations and guidelines.