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 5 years innovating, securing patents and implementing  a smarter, easier way to gather crucial PRO data on behalf of its clients.  We have created 3 solutions spanning simple diaries to the most complex clinical assessments.

Over 4 billion mobile / cell phones are used globally and 60% 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 REACT CELL is as easy as reading a text message
• Fast to deploy, requires minimal sponsor involvement/time

By September 2009, we had supported over 400,000 subjects, in over 50 studies and 60+ countries, delivering over 2 Million text messages. Our clients include 16 of the top 20 Pharma sponsors, as well as a many other biopharma and CRO organisations.

Regular customer surveys conducted at study start-up and study closure have resulted in complete satisfaction with this exciting ePRO technology. This has been achieved by our attention to detail, careful deployment and controlled growth.

We have been profitable since day one and take pride in having a financially sound business that is sustainable through steady organic growth and not dependent on the demands of venture capital bodies.

With over 4 billion mobile phones in the world, 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 the validation process to ensure that the PRO data collected, never lost and is compliant with latest FDA 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

System Validation

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

Medical Scale Validation

We work in partnership with the sponsor and instrument owner.
We ensure reproducibility, accuracy and responsiveness is accurately mapped following the FDA latest industry guidance.

We have most recently validated the WOMAC Osteoarthritis index from paper to mobile phone. This is now called m-WOMAC and is available for use in your studies.

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. Contact us

Note: In December 2009 the FDA updated it's guidance for industry document on ePRO measures. We would be delighted to discuss this with 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.

How can we help your study to succeed?

Please select one of our ePRO solutions above to see which best suits your needs.

When you feel you have all the information you need then let us review your draft protocol and/or provide a quote and a proposal. We can even show you a live demo so you can witness first hand the benefits of Exco InTouch's solutions.

To book a demo, request a quote or speak to an Exco InTouch expert, please use the "I like what I see" form at the top of this page and we will contact you shortly.