“Configurable” and “modular” are claims made by many companies providing clinical IRT (IWR/IVR) services today. Configurable means that system changes can be made to meet the specific needs of a clinical trial without requiring days of coding by a vendor’s development and technical support team. Modular means clients only pay for the functionality they need. Veracity Logic’s VLIRT® solution is built on a configurable, modular foundation that is technology agnostic for integration with other eClinical systems.
Regulatory requirements and plain old common sense make the documented testing and validation of the electronic systems used in clinical trials of critical importance to the success of any clinical study. To put it bluntly, approval authorities around the world will reject clinical data collected by what regulators deem to be substandard means (see, e.g., 21CFRPart11, EU Annex 11, etc)
Veracity Logic is an exclusive IRT (IWR/IVR) vendor, so let’s get into the nitty-gritty of what this means for IRT systems.