You can gather your Patient Reported Outcome (PRO) data in a few ways.
1. Traditional paper diaries – Universally recognised as having inherent problems in terms of data accuracy, integrity and patient compliance
2. IVR ePRO – A better solution, but often not easy or convenient to use for the subject
3. PDA ePRO – Improves compliance and data quality but the cost, time to implement , unsupported devices and significant logistical issues have often created unforeseen problems for sponsors
There is now a more efficient way to gather data from subjects, care givers and sites that is simple and quick to set up and easy to use by all trial participants.
Exco InTouch has spent six years innovating, securing patents and implementing a smarter, easier way to gather crucial PRO data on behalf of its clients. We have created three solutions spanning simple diaries to the most complex clinical assessments.
Over five billion mobile / cell phones are used globally and 70% of the world’s population now own a cell phone. Exco InTouch has harnessed this ubiquitous communication technology for use in clinical trials and healthcare programs with outstanding success and adoption.
Nobody goes anywhere without their wallet, car keys and cell phone which ensures that this technology solution enjoys unrivalled adoption:
• No hardware costs
• No complex devices to manage, buy, ship, import/export then repatriate and store
• Cell phones are always on, charged, available and ready to go, reduces site preparation and training burden
• Patients already know how to use their own mobile phone. Using ePRO CELL is as easy as reading a text message
• Fast to deploy, requires minimal sponsor involvement/time
With over 5 billion mobile phones in the world coupled with the popularity and convenience of the cell phone, what better device to use in clinical studies? Exco InTouch will guide and take you through the validation process to ensure that the PRO data collected, is never lost and is compliant with FDA final guidance.
ePRO validation encompasses two distinctly different aspects:
• System validation – will the system perform as specified and deliver the PRO data for review
• Patient Reported Outcome scale or instrument measurement/validation – for example migrating a paper scale for satisfactory use on a mobile phone
This is a critical part of any Exco InTouch ePRO solution and as such is embedded into our Quality Management system.
Regardless of ePRO platform selected, all solutions are validated according to the Program Specifications developed by the Exco InTouch project management team and agreed with the sponsor.
• We vigorously test the solution and the data collected for:
• Diary usability by the stakeholders – is it easy to use?
• Intelligent branching, logic etc – do the diary pages load correctly
• Data transmission – stress and load testing
• Data review, back-up and retrieval – can we quickly and easily review the data, double checking back-ups work
We work in partnership with the sponsor and instrument owner ensuring reproducibility, accuracy and responsiveness is accurately mapped following the FDA final guidance.
We have most recently validated the WOMAC Osteoarthritis index from paper to mobile phone (m-WOMAC). Other validation studies are under-way. If you are a scale owner and are interested in moving your scales to cell phones, we would be delighted to hear from you.
We are compliant with all industry regulations that affect the collection of self-report data including FDA 21 CFR Part 11, HIPAA and worldwide data privacy regulations. We have been successfully audited many times and invite your regulatory teams to assess our products and overall business.