Update
CROs, Sponsors Look to Service Providers to Comply with US Sunshine Act
A lot of the onus of the new requirements “is being put on the CROs” because they’re the ones making the payments to the investigators and then reporting those payments to sponsors, Steve Ayala, president and CFO of Clinverse, told Outsourcing-Pharma.com. “CROs are in need of systems to track and account these payments, which are typically done manually.”
Many of the contracts between physicians and companies running clinical trials vary significantly and sponsors and CROs are "scrambling to see where to pull the data from" before the reporting requirements of the Act take effect in March 2014, he said. Companies are typically looking for a flexible software tool to track and report their payments, especially as the process of calculating payments can be onerous, he added.
The number of CROs looking for an answer is increasing as the reporting deadline draws closer because "they’re feeling the pressure from the sponsors to adhere to the new regulatory requirements," Kyle Cunningham, VP of product management at Greenphire, also told us. He added that his company offers an end-to-end solution for sponsors and CROs looking to make trial site payments and obtain data on investigator payments.
"CROs are starting to feel a sense of urgency to find a solution," Cunningham said.
Ayala added that his company’s ClinPay tool also offers an end-to-end solution that can adapt to nearly any situation or trial protocol amendment. However, he admitted that Clinverse is looking to partner with other service providers to cover all of the payment categories that are required to be reported to CMS (Centers for Medicare and Medicaid Services) under the new law.
Clinverse announced on Wednesday one such partnership with Aggregate Spend Solutions. The arrangement will allow Clinverse to integrate Aggregate’s software tool for the tracking and reporting of transferred value at investigator meetings or conferences where healthcare providers receive compensation from sponsors in exchange for their involvement.
The partnership also allows clinical trial sites to immediately notify doctors in real time on their expenses, which can then be disputed or accepted by the physicians. This expedited process could remove a possibly conflict of interest when a doctor disputes what a sponsor reports, Ayala said.
He also told us Clinverse is working to develop more “partnerships that capture other significant data and integrate with other systems” before the reporting requirements take effect. He noted that Clinverse’s software tool, which was built over more than two years, offers a complete audit trail for collecting payment data and can automatically debit a sponsor’s bank account in over 140 currencies.
The cost of the software depends on the client’s needs, though Ayala said his company has provided the software to a top five biotech company that dealt with compliance issues in the past, as well as a small sponsor with only one clinical trial.
Greenphire's Cunningham added that the US Sunshine Act is "just the tip of the iceberg" in terms of transparency efforts worldwide. More than 70 other regulations are taking shape and companies will need to have all of their data consolidated into "one core technology," he said.
