From The Editor | September 15, 2016

3 Things You're Doing That Drive Your Sites Insane!

Ed Miseta

By Ed Miseta, Chief Editor, Clinical Leader
Follow Me On Twitter @EdClinical

3 Things You’re Doing That Drive Your Sites Insane!

Many pharma companies have become focused on becoming a sponsor of choice. We believe this comes from the recognition that partnerships are a two-way street. In order for the industry to conduct trials faster, more efficiently, and at a lower cost, sites and CROs need to be better partners to pharma. At the same time, however, pharma needs to be a better partner to sites and CROs. Still, many wonder what it means exactly for a sponsor to be a better partner.

Christine Pierre, founder and president of the Society for Clinical Research Sites (SCRS), knows better than anyone what sponsors could be doing better. She also believes that as an industry, we have gotten quite good at identifying problems, though not as adapt at addressing them. Many of these issues are ones SCRS is intent on resolving with industry stakeholders as collaborators.

At a macro level, Pierre says most of sites’ complaints revolve around slow payments, payment transparency, and tracking site performance.  

“Talk to any site about what should be doing differently, and you will find slow payments at the very top of the list,” says Pierre. “We have all been hearing for a long time that payment terms are too slow and that the payment processes actually create additional burdens for sites. At SCRS, we have been trying to determine what that means and how we can create and promote solutions. Earlier this year, we initiated the Site Payments Initiative (SPI) with the involvement of pharma, CROs, and sites. The initiative is being headed up by three leaders in each of those groups: Norvartis, INC Research, and Hospital Corporation of America (HCA.) The Initiative already has over 40 members from major pharma companies and CROs, clearly pointing to everyone realizing it’s a problem and working collaboratively towards a solution.”

Pierre notes the SPI is working to identify best practices that should be used when it comes to paying sites and the proper framework in which to deploy the payment.  Although the timeliness of payments is a major issue with sites, another issue following close behind is the lack of transparency surrounding payment transactions. Transparency issues mean finally receiving a check can be just the beginning of a site’s difficulties.        

What Is This Check For?

Most businesses understand the frustration of receiving a check in the mail and having no idea what it is for. However, for sites it’s an occurrence that is more common than not for payments they do receive.  Imagine working for multiple pharma companies and having that scenario be a regular occurrence. Pierre notes a site might get a check for $17,052. However, it will come with no notes and no backup documentation. When received, site personnel will often have no idea what the check is in payment for, which then creates confusion and further delays the process of getting it posted.

“When a check is received, personnel need to know how to apply it,” says Pierre. “If there is no supporting documentation, a site will have to spend numerous hours calling the sponsor or CRO to track down information about the payment. Everyone wants and expects sites to operate as sustainable business entities – no business can be sustainable if they cannot properly reconcile and manage their cash.”

A Pain Point For Sites

Unfortunately, Pierre sees too many companies addressing these payment concerns in a one-off manner. She believes the industry needs to establish standards for all companies to adopt. She hopes this is something that will come out of the SPI. The first round of recommendations from that Initiative will be revealed at the SCRS Global Solutions Summit in November 2016. 

Pierre also notes this is an industry that has embraced outsourcing, and there are now vendors dedicated to solving the issue of site payments. If a sponsor or CRO does not want to solve the payment issues internally, they can outsource the responsibility to a willing vendor. “I don’t know all of them and SCRS does not promote any of them,” she says. “But you can spend years building this capability internally or, you can just outsource it. The choice is up to you, but the sites need to be paid timely following standard accounting practices (sending backup information with checks).”

The payment issue is not a minor one. Greenphire, a company that specializes in payments, recently conducted a survey of over 500 sites to determine the extent of the problem. The survey found 63 percent of sites were receiving quarterly payments. “It would be bad enough if sites had to wait 90 days to get paid,” says Pierre. “In reality, quarterly might actually mean 3 months plus typically another 45 days for the check to be cut.  That adds up to almost 5 months.”

Sixty percent of the sites taking part in the Greenphire survey also reported that quarterly payments will negatively impact their operations. Pierre notes she has spoken to site personnel who have said they will pay less attention to studies where they are paid on a quarterly basis, focusing instead on those with more fluid payment options. If they don’t have enough money to pay additional personnel involved in patient screening, they may have to delay screening more patients until they are paid. The reason is simple: Sites need the cash. In fact, many sites do not even have 3 months of operating cash on hand. Expecting them to float that work for five or six months before getting paid is simply not realistic. It needs to change.

Take Care Of Your Productive Sites

In addition to slow payments and the lack of payment transparency, Pierre cites sponsors/CROs not going back to sites that have performed well in the past as another issue that must be resolved. She identifies part of the issue being related to a shortfall on a lack of meaningful metrics and tools needed to track investigator performance.

“Within a pharma company, there are different therapeutic areas,” says Pierre. “Those companies often do not have one consolidated database to track investigator sites and their performance. If one therapeutic area uses a site and has stellar results, the other therapeutic areas may not even know the site exists. Sites that perform well often have skill sets that are transferrable to other therapeutic areas. The lack of a centralized database of site performance creates a huge missed opportunity for the entire industry.” 

TransCelerate is currently working on an investigator portal, and Pierre believes this provides a glimmer of hope that in the near future there will be some consolidation of the investigator databases of TransCelerate members. Unfortunately, TransCelerate only has 19 pharma members. The industry is comprised of hundreds of pharma companies. Getting the majority of companies onboard will be a greater challenge.

Creating better relationships between sponsors, CROs, and sites will not happen overnight. But the first step is acknowledging the problems and identifying possible solutions. “No one will be able to do this alone,” adds Pierre. “This effort will involve sponsors, CROs, regulators, vendors, patients and sites all working together. If we do it right, the end result will be better, faster, and more efficient trials. And that result will be well worth the effort.”