Making Your ePRO Decision

The evaluation of ePRO (electronic patient reported outcome) providers has matured as the market has evolved, and remembering every factor among providers can be challenging. For your convenience, PHT has assembled check-lists of proposal and corporate evaluation criteria, based on what we hear from current and prospective clients, to help you move efficiently through the ePRO provider selection process.

Experience & Global Scale

Assures you that the provider has encountered unique situations and will be able to use learned best practices for your study needs. Experience factors:

• Number of clinical trials conducted
• Countries and languages supported
• Therapeutic areas covered
• Scientific support to assist in diary design (ediary systems)
• NDA submissions
• Number of clients and repeat customers

Comparative Pricing

There is no standard pricing model set in the ePRO industry. Therefore, when you evaluate pricing, make sure all elements are included so you can ensure a fair comparison of prices and, most importantly, avoid change orders down the road. You will need all of the following services during your ePRO study:

• Project Management (pre- and post-deployment)
• Scientific consulting
• Specification, programming, and testing of devices, reports, user acceptance test period, data summaries and data transfers
• Hardware procurement (lease or buy) and telecom usage (analog or wireless)
• Study monitoring post implementation: status reports, issue tracking, and management of key success factors
• Global inventory management
• Telecommunication testing
• Server hosting
• Trial closeout including data clarifications, hardware returns, final data transfers
• Archive delivery (What does the archive include? Does it meet the minimum standards to recreate the trial?)

Help Desk

Not all help desks are as truly helpful as PHT's Study Support Center. Review the following criteria when making your ePRO provider decision:

• Is it outsourced or internally managed?
• How is the staff trained on client studies?
• What are the hours?
• What languages are supported?
• What is the average first-call resolution rate?
• What is the escalation process to tier-2 and tier-3 support?
• What are the contingency plans if your end users require additional hours and/or languages?

Implementation Process

Ensures consistent delivery and efficient logistics management throughout the duration the trial.

• Is it a formalized process and who is responsible for what?
• Are standard software development practices utilized?
• Are SOPs written and followed? How is this verified?
• How are issues communicated and resolved to clients?
• Is there evidence that project teams have been trained?
• Are all implementations executed in the same manner?

Data Integrity

Often overlooked, technical security measures are critical to preserving data integrity.

• What security measures are in place (software and physical security) to ensure data integrity?
• Are these systems constantly monitored?
• How does the system ensure data cannot be lost on the device and on the server?

Company Stability

Most ePRO providers do not approach the size of their pharmaceutical customers; you must be confident that you are working with a well-managed and fiscally responsible provider.

• Turnover rate at executive level and general employee base
• Financial growth and stability
• Years in business, customer references

People

Sponsors should assess the "gut feel" fit with the people you will be working closely with to implement the ePRO solution.

• Experience levels of project managers and project coordinators assigned to your trial
• Will your project team stay with the trial throughout its duration?
• Was the exchange professional and pleasant with the people you have met?
• Did the company provide the requisite information and address any issues in a timely and helpful manner?

What's NOT Included?

It's important to understand what is not included in the pricing as these fees can be a costly surprise if not considered when creating the budget. Some fees that may not be included in the price which you will incur:

• Translation fees
• Device shipping
• Telecommunication charges
• Hardware (How many devices were included? Lease vs. buy? Are there sufficient modems for the amount of analog devices used?)
• Translated training materials and reference manuals
• Power adapters for international trials
• Phone cords and chargers if necessary
• Pre-paid shipping forms for convenient returns

Learn More About Choosing an ePRO Provider

What are common change orders than can arise if the trial isn't planned and contracted properly? What other factors should I consider when evaluating providers? Contact PHT for answers to these questions or any others you may have.