Case Study: Columbia discovers fiscal benefits with clinical trial oversight
Columbia University campus
At Columbia University Medical Center in New York City, prior to the overhaul of its previous Clinical Trial Management Solution (CTMS), the facility held minimal oversight over its payment cycle, and information on sponsored clinical trials was not available and unaccounted for, said Susan Adler, research applications administer of the clinical trials office (CTO) at Columbia during a webinar yesterday sponsored by StudyManager.

Prior to rolling out its new CTMS, Columbia had difficulty tracking specific budgetary items and failed to spot pertinent revenue opportunities, particularly in regards to clinical trials.

At that time, Columbia had a majorly “decentralized” system where management and budget inquiries took place independently throughout various departments. At some level the CTO would manage and maintain trial data; however, Adler said that Columbia “did not have a process of reconciling these payments back to the clinical trial.”

Columbia’s previous CTMS, said Adler, was a home-grown solution that provided the facility “a flat-file database that captured trials that were active and would indicate how much the budget was worth. We required a more effective means of managing our data." The prior CTMS system used at Columbia “did not capture patient activity and only tracked payments that we received,” she said.

Last year, Columbia decided to replace its existing CTMS system to provide better oversight, exude better financial management and track clinical trial information to gain better payment results.

Adler said, “The entire university was being challenged to become more efficient and streamlined in its use of revenue and indirect costs. Our investigators were required to find ways to cover the bottom line using the full portfolio of their funding streams, which, of course, included clinical trials revenue.”

The university first began rolling out the new solution in a six-month pilot program in three of its divisions. The pilot program worked to move budgetary information for clinical trials into one centralized database and looked at surgical, medical and device clinical trial revenues and payments that were then built into and tracked by the CTMS.

“The goal during the pilot program was really to create a champion of the system so that users of the system could speak to the successful nature of the project as we rolled it out,” said Adler.

During the selection process, Columbia worked with Huron Consulting to assess what solution would best suit its needs. With the help of Huron, Columbia evaluated various CTMS via a scorecard equipped with 133 requirements.

The score assessed four areas: financial, regulatory, clinical and administrative. The financial criteria evaluated Columbia’s need for its CTMS to perform financial tracking, budget creation and report billable hours, among other factors. 

According to Adler, the new solution provides Columbia an easy way for the CTO and departmental managers to build a study and report into the solution to track real-time revenue accruement, earned revenue, invoices and payments.

The CTMS, utilized by 150 employees in 44 departments, has already evaluated more than 400 industrial studies and has filed data for more than 2,000 patients. Since its installment, Adler reported that Columbia research coordinators have already entered $15.8 million in earned revenue and $14.7 million in received revenue or cash receipts.

The technology alleviates manual data input and tracking by means of Excel spreadsheets, and provides an opportunity for the university to gather better payment. Another feature of the system allows facilities to track and get better reimbursement for one-time fee payments that are usually put on the back burner and left unpaid such as IRB form fees and document storage fees, said Bruce Lewis, a senior project manager for StudyManager.

Compared to the prior system, the CTMS better looks for misrepresentations in payments and invoices and can even alert the CTO office of problems to help catch mistakes, Adler noted.

Additionally, Adler said that the CMTS provides a more accurate representation of patient enrollment and gives better attention to the budget.

In 2010, Columbia will begin launching its "e-repair project," aimed to ease the complicated, manual and often "cumbersome" process of billing. Adler said that often because sponsor and facility prices differ, the billing process becomes difficult. Columbia will look for ways to more accuratly report payments by building an electronic process to create reconciled billing reports. "This will change a lot of work that is manual," said Adler.

Adler concluded: “Having this information available has really shifted the way we are doing things in the clinical trials office and, of course, with the valuable data, we are finding new ways to present and evaluate.”