Case Study -

eSTUDY SITE                                                                                           

Challenges

  • Delays in closing monthly financials
  • Inefficiencies in determining and collecting accounts receivables
  • Difficulty identifying personnel with knowledge and experience in the clinical trials industry

Solutions

  • Outsourcing Contract Administration to PFS Clinical, the industry’s only company focused exclusively on financial management of clinical trials

Results

  • Ability to close monthly financials in days rather than weeks
  • Resources redeployed to other, more strategic activities
  • Recovery of tens of thousands of dollars in “lost” revenues

Investigative Site Improves Financial Management of Clinical Trials

eStudy Site is a San Diego-based enrollment and research organization that provides inpatient and outpatient clinical research services to pharmaceutical and contract research organizations (CROs). Since its founding in 1999, the organization has operated with a clear and compelling mission: to be the most efficient, productive, inpatient and outpatient research site in the world.

Today, eStudy Site provides a comprehensive, effective approach to the recruitment, enrollment, and retention challenges that clinical drug trial sponsors and CROs typically face. In fact, eStudy Site has refined a proprietary patient enrollment methodology for rapidly screening and enrolling large numbers of subjects into studies. This unique system significantly accelerates the approval process timeline for new drug therapies and reduces overall research costs.

Even with industry-leading systems and processes, like many clinical trial sites, eStudy Site still faced challenges in the area of financial management.

Using In-House Resources

Until 2007, eStudy Site relied on in-house resources for financial management of its clinical trials, which number around 20 at any given time. Says the Chief Financial Officer (CFO), “We had invested in study management software, which we had originally hoped would provide both clinical and financial support,” he explains. “But we were finding that there wasn’t sufficient support from the software developer to really implement the level of financial detail we needed.” Thus, even with the software, the organization was still having ongoing issues with identifying how to apply payments received to open invoices.

The CFO says there were human resource challenges as well: “Because this is such a specialized industry, it was virtually impossible to find accounting personnel with knowledge and experience with clinical trials. As we would bring people in, we would have to train them from the ground up, and there was always a long learning curve.”

After realizing that the software package alone wasn’t sufficient to meet eStudy Site’s financial management needs—and after dealing with multiple rounds of turnover in the accounts receivables staff—the CFO began exploring other options.

After hearing about PFS Clinical, the CFO met with the company to learn more about its capabilities. He then performed an analysis comparing eStudy Site’s in-house approach to PFS Clinical’s outsourced model.

In the end, the CFO won the approval of the Board of Directors, and in February 2007, eStudy Site signed on for PFS Clinical’s Contract Administration services.

Transitioning to an Outsourced Approach

The CFO says the transition to PFS Clinical was flawless, in part because he and his team worked extensively with PFS Clinical in advance. “We talked through exactly how they would go about the transition,” he says. “It was clear to me that they understood what needed to occur, and once we pulled the trigger, the transition was very quick and painless.”

PFS Clinical initiated the reconciliation process the same month the contract was signed, and started handling billing and accounts receivable in mid-March. The impact was immediate, the CFO notes.

For starters, in the reconciliation process, PFS Clinical identified$143,000 in net additional revenue that had not been recognized. That revenue consisted of patient activity, as well as passthrough costs that needed to be invoiced to the sponsors so that eStudy Site would be paid for them—all of which had a direct impact on eStudy Site’s bottom line.

Although eStudy Site’s clinical staff members continue to rely on the study management software for their day-to-day tasks, all of the organization’s billing and accounts receivable activity is handled by PFS Clinical. There have been marked improvements there, as well.

“PFS Clinical very rapidly helped reduced accounts over 90 days,” he says. “In fact, most of our accounts are now concentrated in the zero to 60-day category.” Other benefits have included greater availability on the organization’s line of credit, as well as a decrease in interest cost.

Enjoying Expert Support

For the CFO, the biggest benefit of outsourcing to PFS Clinical is simple: knowing that this aspect of eStudy Site’s accounting and finance is going to be handled in an accurate and timely manner.

“This function isn’t a core competency for our business to succeed relative to our client deliverables,” he explains. “It’s been a relief to offload it and be able to rely on the timeliness and integrity of the data.”

Prior to outsourcing, it would take the staff up to three weeks to close the books each month. Even then, he says, they would often find something missing. “Now we know our revenue numbers within three days, and we’re able to generate preliminary financials and make better decisions based on that information,” he notes.

This CFO urges other investigative sites to consider the power and simplicity of outsourcing to PFS Clinical: “Don’t waste your time trying to recreate the wheel,” he says. “It already exists. For our site, the value of these services far outweighs the costs.”

Even better, he says, “You’ll be able to sleep better at night, knowing you can rely on the data you’re given. That speaks volumes.”

Finance Director Lew Schwartz says, “We’ve been pleased with the benefits from this partnership from the beginning. It’s been a win-win.”

Get Started Today

The management of clinical trials will never be simple. By enlisting the support of PFS Clinical, you can finally implement a best-in-class solution — and start enjoying the benefits of our services to help improve and enhance your clinical trial administration. (608) 664-9000 | questions@pfsclinical.com