CRF Health, a specialist provider of patient centred eSource technology and service solutions for the life sciences industry, has been selected by a specialist pharmaceutical company for its latest paediatric rare disease Phase II study.
The trial will utilise CRF Health’s TrialStudio, TrialMax and TrialManager eCOA solutions to collect quality of life readings and capture compliance data for caregivers (predominantly parents) throughout the study.
Specifically, the TrialMax Touch handheld mobile devices will be used as a practical solution. This will alleviate the burden of data entry, easily integrating into the lives of the caregivers who will be administering twice weekly injections.
For this study multi-users will have access to the platform for one subject, enabling two caregivers to enter data. Expected to start screening patients before the end of 2017, this pioneering clinical trial will cover 50 sites and include 150 patients in 15 countries for a period of two and a half years.
Common challenges in rare disease trials include patient recruitment, capturing meaningful, comparative data, patient engagement and retention, and logistics and scale.
Due to the small number of patients enrolled in this rare disease study, ensuring enough data is collected to make actionable decisions is more challenging and significant effort is needed to make every data point count.
Mobile, intuitive and easy-to-use, TrialMax Touch fits into the subjects’ real lives to fuel high compliance and complete data.
Rachel Wyllie, CEO at CRF Health, said: “We are proud to support this company’s commitment to offering physicians and patients new treatment alternatives in areas of unmet medical need. CRF Health is providing a unique solution for this study in addition to our traditional eCOA offering with our class 1 medical device utilised as a medication reminder and log, which is something not all eCOA providers can deliver.”
“Our design process, powered by TrialStudio, was pivotal in securing this contract. It provides a collaborative, interactive and agile approach to the entire process and we are delighted to be involved in a trial that will offer a significant amount of value to a rare disease that has very limited treatment options.”