Interactive Voice Response Systems (IVRS)

As a leader in IVRS technology, PPD has custom-designed, coded and individually validated more than 300 IVRS solutions worldwide, supporting 40,000 total sites with more than 250,000 subjects.

Our dedicated team of experienced professionals delivers the following suite of IVRS services to our clients:

• Patient screening
• Enrollment tracking
• Centralized randomization
• Study drug management
• Dosage titration monitoring
• Patient discontinuation/withdrawal tracking
• Emergency code break
• SAE coordination
• Patient diary data collection

Experience

Using IVRS, we have managed studies with as few as 20 investigator sites to as many as 5,000. In terms of patients, we have randomized as few as 80 patients to as many as 25,000.

Our largest multinational system comprised 12 countries in nine languages and six drug warehouses supported more than 4,000 sites to randomize over 25,000 subjects in a four-month time frame. We also took more than 200,000 calls and placed more than 32,000 drug orders to manage run-in, randomization and titrated visit re-supply drug. This was all done within a six-month treatment period.

Benefits

As a leader in the industry, PPD has the experience and technology to offer the following benefits to our clients:

• Reporting capabilities that can be incorporated with other PPD service reports along with outside vendors to provide a one-stop shop for key study information
• Immediate follow-up by one or more confirmations dispatched via fax or e-mail on all completed IVRS transactions
• Compliance reporting for subject visits, drug order confirmation and diary data collection
• A dedicated staff for IVRS development projects in the United States and Europe that provides design, development, user-support systems, database support and validation
• A proprietary automated validation system to place a high volume of simulated calls to a given system and report IVRS performance results analysts produce the expected results and capture the actual results electronically to confirm all IVRS components are working together as intended
• IVR systems are designed, developed, validated and maintained according to the standards set forth in 21 CFR 11; PPD continually monitors the opinions of the FDA and other regulatory agencies to ensure continued compliance
• Standard IVRS modules are available for a more “off-the-shelf” approach saving both time and money for the more straightforward studies