Technology Helps Trim Reimbursement Times

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Eighty-five to 90% of clinical trials have a stipend or travel reimbursement to compensate subjects for their participation. While reimbursement amounts may not be large from the perspective of industry professionals, the payments can still make a difference to a volunteer. Greenphire CEO Sam Whitaker says, "Many studies typically deliver reimbursements on a monthly or even quarterly basis. And it may only be $50, but even four to six weeks can be a long time for a patient to wait to receive his payment, especially when a real cost is incurred to participate, and for these patients $50 is important."

Thus the heart of Greenphire's ClinCard System, designed to execute clinical subject payment and subject messaging to improve the patient's—and the site's—experience. "Happy patients and happy sites equate to happy studies," says Whitaker. Implementing an automatic, electronic, patient-facing tool for a clinical trial is why Greenphire was chosen for subject payments in the first ever virtual and patient-facing REMOTE clinical trial currently being conducted by Pfizer.

About four years ago, Whitaker and two other colleagues were working in product development at Citigroup to structure pre-paid debit card solutions in other industries. Whitaker, whose fiancée was working in clinical research, eventually left Citigroup and a couple months later started his own business with the ClinCard as its flagship product. He amassed a Board of Advisors, including Neil Rotherham, the founder of ClinPhone, and built Greenphire's original ClinCard solution, marrying subject payments with text messaging and other forms of electronic communication.

"When the card is loaded, the system recognizes milestones and sends text, e-mail, or voice messages to patients. These messages, in conjunction with the convenience of real-time payments, reduce the number of patients lost-to-follow-up and help increase retention and participation, which drives protocol compliance," explained Whitaker. The system is neatly packaged and uses a web-based portal that is managed by site coordinators and study teams. It can use data feeds from the IVRS, EDC, or CTMS to execute milestone-based payments, or flag items where attention needs to be paid by payment approvers using the ClinCard System's portal.

In the REMOTE trial, however, the ClinCard's functionality is limited to delivering subject payments, as the text messaging functions are handled by the eDiary cell phone-based solution provided for the trial by Exco InTouch (Applied Clinical Trials, September 2011).

Whitaker had noted that prior to the Pfizer study some clients wanted to break the messaging solution out of the original ClinCard System, so Greenphire also established a standalone Subject Messaging System. However, Whitaker believes the ClinCard System ideally incorporates both the payment and the communication features to eliminate unnecessary burdens on the site coordinator's daily routine.

For Pfizer's REMOTE trial, discussions about using the Greenphire technology began as early as spring 2010. Other vendors in the virtual trial chain include the aforementioned Exco, as well as Mytrus, which serves as the single coordinating center for patients, recruitment, the principal investigator, sub-investigator, and the coordinators; and Perceptive Informatics, which provides IVRS. Greenphire works directly with Mytrus, and the ClinCard that is distributed to participants based on subject IDs is Mytrus-branded and funded by Mytrus. "We didn't realize the impact it would have," Whitaker said. "It creates a real-time way for patients to receive the stipends and reimbursements they deserve. The funds automatically get loaded as they leave the site, providing access to funds immediately and eliminating a lengthy delay. This is one of the ways we are improving the overall patient experience in the clinical environment."

For a more visual take on how the patient ClinCard experience works, view the Mytrus video at http://bit.ly/lLTwFj.

Greenphire signed its 100th site client to the ClinCard System in mid-July, has contracts with nearly 40 sponsors and CROs, and has partnered with Mytrus to provide the ClinCard for a number of upcoming virtual studies. However, there are still challenges with the ClinCard. Whitaker said, "It is not easy to drive adoption of a new solution in our industry, which is generally slow to adopt new technology."

But if happy patients who follow through to the end of a trial and beyond isn't enough, Greenphire is addressing another clinical trial "pain point" in its next generation solution—the delay for sponsors in delivering site and investigator payments. Greenphire's eClinicalGPS is a global clinical payment system that automates payment delivery from sponsors to sites, investigators, and vendors.

Whitaker explains that traditionally CROs take on these payment tasks, a manual and expensive process. The CRO can charge anywhere from $100 to $200 per site payment. Greenphire strives to reduce these costs by 70% to 75% per payment.

eClinicalGPS' also facilitates faster site payments and centralizes invoice payments for sponsors, enabling any Sunshine Act disclosure requirements.

While both of Greenphire's existing technologies address real needs in the clinical trials industry, Whitaker believes technology will continue toward a more patient-centric model in the next five years. —Lisa Henderson

Editor's Note: CBI's Patient Centricity in Clinical Trials conference is January 2012. http://www.cbinet.com/conference/pc12013.