Clinical Research Organizations

Clinical Research Organizations

IVR systems (IVRS) and other Interactive Response Technologies (IRT) are increasingly used in clinical trials to enhance process efficiency, consistency, and patient safety.  The benefits range from reducing manual procedures whereby risk is reduced to lowering the material and labor cost of conducting a trial.  Sponsors and CROs have turned to IVRS to perform or enable functions such as:

  • Randomization in blind studies
  • Patient Reported Outcomes (ePRO)
  • Electronic Data Capture (EDC)
  • Distribution/Inventory Management/Drug Pooling
  • Dispense to participants

Implementing an IVRS or IWRS for these purposes requires adherence to GxP guidelines for documentation, development, qualification and validation.  This rigorous approach is intended to ensure the integrity of study data and therefore of the trial itself.

A VoiceVision® Evaluation will give you a clear understanding of how well your systems have been engineered and maintained in light of GxP regulations.  Our 14 Point Diagnostic will look at areas important to you such as:

  • Design (protocol, user requirements, randomization specifications, functional and configuration)
  • Validation (traceability matrix, functional test documentation, OQ, PQ)
  • Change Control and Risk Assessment process
  • Scalability of IVRS application and infrastructure

Whether you are a sponsor or a CRO, we can help you gain piece of mind or identify areas of improvement so you can manage your trials efficiently and effectively while lowering risk.  The use of IVRS technology is steadily gaining widespread acceptance in clinical research.  Smart investment in your IVRS and telco infrastructure will prepare you to scale for future studies and protocols.

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