The collaboration will combine Medidata’s cloud-based technology with Icon’s ready-to-use, pre-validated surveys, which provides sponsors with an ePRO solution that could reduce costs, save time and enhance patient engagement.
Anne Zielinski, global lead for Medidata’s cloud, told Outsourcing-Pharma.com that the collaboration builds on a 10-year relationship between the two companies. “The partnership announced today was directly related to Icon’s acquisition of Oxford Outcomes, which is a leader in providing guidance around and testing for validated psychometric instruments that can collect data from patients in clinical trials.”
Medidata introduced a mobile app that allows patients to input data onto smartphones and tablets, and from which patients will be able to complete the validated questionnaires.
“What we’re doing now with Icon is building these questionnaires into a library and pre-validating them to make the process more efficient,” Zielinski said.
Available on any iOS device and automatically unified with Medidata’s platform, Patient Cloud provides electronic patient questionnaire and diary functionality to simplify the setup process for research organizations, which may have been previously burdened by customized software and proprietary devices.
In addition to general questionnaires, “there are also probably about 15-20% of these types of questionnaires that are specific to a therapeutic area – haemophilia or Crohn’s disease, for example – and they’re used across a broad range of therapeutic areas,” Zielinski said. “What we’re seeing is tremendous growth in these types of questionnaires…we’re continuing to build a library based on sponsor requests.”
As far as savings is considered, Zielinski couldn’t put an estimate on the amount of time a sponsor may save, but she said “the quality of data collected is tremendously higher” because the data can be deployed on smartphones and tablets, which means the source data doesn’t need to be verified or transcribed – “it’s available immediately for review and in many cases can have an impact on the safety of subjects…we anticipate that the safety of patients will be increased.”
And in simplifying the data capture and patient participation processes, Medidata claims its ePRO solution is transforming the clinical trial experience for study participants at a time when capturing the patient voice is becoming increasingly important.
“We’re thrilled to be expanding this partnership and share ICON’s commitment to bringing the voice of the patient to clinical research,” said Glen de Vries, Medidata’s president. “Together, we’re changing how the industry conducts clinical trials by making ePROs applicable to a wider array of studies, reducing the work required to use them and eliminating pain points such as equivalencies and other complicated processes.”