CHAPEL HILL, NC, UNITED STATES - Feb 17, 2015 - Rho, a contract research organization (CRO) focused on bringing new products to market through a full range of product development services, offers tips and considerations for implementing electronic patient reported outcomes (ePRO) on tablet devices, based on a recent application in a large phase 3 pain study.

“ePRO can be a challenge to implement, but often provides higher quality data,” said Emily Cantrell, senior director of operations for Rho.  “Our study was a pivotal study, and we used an ePRO system to collect our primary endpoint - with devices kept at sites and data entered only during study visits - which provided many learning opportunities for our implementation team.”

Key considerations for implementing ePRO and smart devices from Rho include:

• Validation:
  1. Depending on the stage of development your study is in, and if ePRO will be used to record the primary endpoint, validation may be required.  
  2. In the Rho example, data was collected to measure pain on a visual analog scale (VAS), and the scale was validated by recording results on tablets, on paper and via an interview, with results compared to determine the validity of the tablet questions.
  3. If validation is required, a third-party vendor is often used, which can increase costs significantly, so be sure to budget accordingly.

• Study Start-up and Site Issues:  

1. Before beginning the trial, technology at each site must be evaluated - from available and reliable WiFi connections to firewall considerations.
2. Confirm storage at each site and set up charging stations to maintain battery life of each device, preventing loss of data in the event of battery failure prior to sending data.
3. Train the study team, site staff and investigators to ensure comfort with the tablet, accessories and software, as well as username and password rules - for audit and trial compliance purposes, it is important that each team member has and uses their own password.
4. Determine a back-up system in case something goes wrong - a paper system must be identical to the ePRO system, including language options.

• ePRO Vendors

1. Review bids carefully to ensure all study needs are covered - validation, support time, extra devices to serve as backups, etc.
2. Ask for specification of devices and accessories, including plans to change or upgrade devices during the course of the study.
3. Be involved in user acceptance testing (UAT) for the device, and don’t be afraid to test other scenarios to confirm the device is working appropriately.
4. Choose a method for handling support - technical support through the vendor or frontline support through your own client support call center.
5. Ask for vendor recommendations from trusted site staff who may have previous experience with various systems.

“This process provided a unique learning opportunity for our team,” added Cantrell. “The quality of the data, and duration and scope of the study made ePRO a good choice for our study, and we look forward to applying the lessons learned for future customer studies.”

To learn more about Rho, please visit www.rhoworld.com.

About Rho

Rho, a privately-held, contract research organization (CRO) located in Chapel Hill, NC, provides a full range of clinical research services across the entire drug development process. For more than 25 years, Rho has been a trusted partner to some of the industry’s leading pharmaceutical, biotechnology, and medical device companies as well as academic and government organizations. Our commitment to excellence, our innovative technologies, and our therapeutic expertise accelerate time to market, maximize returns on investment, and lead to an exceptional customer experience. Please follow us on Twitter.

###