Electronic Patient Reported Outcomes

Regulators, Sponsors and CROs are focussing more on the role of the patient in Clinical Trials than ever before. Exco InTouch simplifies the ePRO process for Patients, Sites and Sponsors, providing greater access to better quality data - more cost effectively.

Since 2004, Exco InTouch has been building a smarter, more user friendly and patent pending mobile platform to gather crucial PRO data on behalf of its clients.  We have created 3 solutions spanning simple symptom diaries to the most complex clinical assessments.

Over 5 billion mobile / cell phones are used globally and over 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.

Since nobody goes anywhere without their wallet, car keys and cell phone this proven technology solution enjoys unrivalled adoption amongst patients, sites and sponsors who have been introduced to it. Use of this service enjoys the following benefits:

• Greatly reduced hardware costs
• No complex PDA devices to manage, buy, ship, import / export then repatriate and store
• Cell phones are always on, charged, available and ready to go which significantly reduces site preparation and training burden for all involved
• Patients already know how to use their own mobile phone. Using mobile ePRO is simple and easy to use as easy as reading a text message
• Rapid build time requires minimal sponsor involvement / time to specify and deploy the study specific solution

By June 2010, we had supported over 500,000 patients, in 60+ countries, delivering over 3 Million text messages. Our clients include 16 of the top 20 Pharma sponsors, as well as a many other CRO and Biopharma organisations.

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

Customer Support

Exco InTouch prides itself in providing the right solution for your study and patient population. This extends to the provision of support to all stakeholders in the study and we will ensure that all users receive the optimal level of support throughout the trial. Exco InTouch solutions are based upon the automated interaction between sites, patients and the study protocol so support queries are minimal. However, all requests that require personal contact are handled by subject matter experts according to agreed service levels and resolution urgency. Exco InTouch support is provided no matter what the geographic location of stakeholders involved in the study.

Validation

With over 5 billion mobile phones in the world being used every day what better device to use in support of clinical studies for patient and site communication and engagement? 

Exco InTouch will guide you through the validation process to ensure that all patient and PRO data collected is always available and compliant with all FDA requirements and guidance and worldwide data privacy mandates.

ePRO validation encompasses two distinctly different aspects:

• System validation – will the system perform as specified and deliver accurate PRO data for review
• Patient Reported Outcome scale or instrument measurement/validation – for example migrating a paper scale for use on a cell 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 the mobile 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 and intuitive to use?
• Intelligent branching, logic - do the diary pages load correctly and in the sequence expected?
• Data transmission - stress and load testing  for maximum load volumes
• Data review, back-up and retrieval - can we quickly and easily review the data and archive a full audit trail of all system interactions

Medical Scale Validation

We work in partnership with the sponsor and instrument owner to ensure that reproducibility, equivalence, accuracy and responsiveness is accurately mapped to conform to the FDA's Final industry guidance on ePRO collection.

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, please Contact us as we would be delighted to hear from you.

Note: In December 2009 the FDA updated it's guidance for industry document on ePRO measures. We would be delighted to discuss the implications of the guidance for our cell phone solution with you.

Compliance

Our solutions are designed to be 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.

What Next?

How can we help your study to succeed?

Please review our ePRO solutions (eprosms, eprocell or eproapp) to see which best suits your needs.

When you feel you have all the information you need then we are always happy to discuss your draft protocol and provide our recommendations. We can even show you a live demonstration so you can witness firsthand the benefits of the Exco InTouch ePRO solutions.

To book a demonstration, request a proposal or to speak to an Exco InTouch expert, please use the "I like what I see" form on the right of this page and we will contact you shortly.