Clinical Trial Mgt. System Boosts Bottom Line

By Alec Fishburne and Malia McFatridge

Since 1989, the Lynn Health Science Institute (LHSI) has been conducting comprehensive medical research. Bringing new drugs to market through its clinical trials program, LHSI has extensive experience in a number of areas, including chronic digestive diseases; cardiovascular diseases and hypertension; disorders such as asthma, lung infections, and cystic fibrosis; women’s health; urology; rheumatoid and osteoarthritis; and sleep disorders.

LHSI has completed more than 300 clinical trials, working with more than 200 pharmaceutical companies and CROs.

As a busy, growing research organization with multiple site locations, LHSI needed a way to manage the dozens of clinical trials the sites could be conducting at a given time. To produce its reports, LHSI had previously relied on data collected in spreadsheets. However, this method was extremely time consuming. Employees had to manually complete a spreadsheet record of their activities, which required merging various files to complete the reports. And many times, reports contained incomplete or inaccurate data, resulting in delays in getting reports finalized. LHSI was spending at least one week per month collecting data from the spreadsheets, ensuring the data was complete and accurate, and finally generating reports. Seeking a solution, LHSI, which had previously worked with StudyManager and knew that its CTMS (clinical trial management system) product would help improve its workflow, implemented StudyManager Reveal to manage its clinical studies, and is now realizing a variety of business benefits.

Real-Time Monitoring
The ability to measure revenue in real time is critical to any business, as a current revenue position is essential in understanding progress made toward revenue targets. Previously, LHSI had only month-end revenue metrics, with no efficient method to gauge progress prior to month end. In the absence of key benchmarks, identifying efficient, data-driven course corrections to successfully impact month-end financials was a challenge.

“We couldn’t monitor benchmarks or look ahead at what we could anticipate in terms of expected patients and appointments,” says Christine Ferguson, assistant director of finance, LHSI. “For example, our coordinators have a specific number of patient visits they need to complete to help us meet our business goals. Because our coordinators reported their patient visits to us only at month’s end, we had little indication as to whether we would meet our business goals for the month until the month was already over. It would take our coordinators about a week to enter data into spreadsheets. Our department then had to review and analyze this data and recompile the data into revenue reports.”

This process is now automated by the Reveal application. Instead of a collection of workbooks and worksheets, all of the studies and data on patients are now in one central system. The company can set its users’ permissions so that only their own studies and patients are visible. There is no longer a need to merge various files together in order to create reports because the reports LHSI has built into Reveal provide the company with updated results in one central location.

Ferguson adds that operational and financial planning is also more effective with Reveal. “Throughout the month, we can assess where we are in relation to our goals. It’s a much more proactive approach that the after-the-fact, month-end reports don’t allow. If it seems we aren’t on target for the current month’s goals, we can assess upcoming visits since our coordinators also schedule their study patient appointments in Reveal.”

Faster Payment Processing
At any point in time, LHSI may be involved in dozens of clinical trials, which made generating reports a labor-intensive process. Using Reveal, LHSI has cut reporting times down from a week-long process to just a few hours.

“Our previous method was extremely cumbersome. We needed a better way to streamline data collection and reporting, as well as a more accurate method for tracking coordinator productivity and amounts we owed to our service providers,” says Ferguson. “With Reveal, we don’t have to spend as much time trying to collect the information we need. Now our coordinators can quickly record the information we require, spending less time on data entry and devoting more time towards making each study a success. As a result of this time savings, our productivity has improved dramatically.”

Reveal also has helped LHSI reduce time spent on payables, which are built into Reveal up front. “It used to be a week-long process to gather spreadsheets, approach each coordinator with reminders to submit any missing or incomplete information, and then consolidate that data in order to cut checks. Now we’ve reduced the process down to a matter of hours. Our coordinators can log in to Reveal and track their completed visits, and Reveal records the appropriate revenue and payable amounts instantly and simultaneously,” Ferguson says.

Reaping Multiple Benefits
Reveal’s document tracking feature provides central management of study files, which helps LHSI meet regulatory requirements by ensuring the most recent, approved documents are available to users. “Ensuring use of the correct study documents is much easier now, as we have the ability to upload them to a secure location, accessible from wherever the coordinator is working that day,” adds Ferguson.

Another advantage of using Reveal is enhanced business development efforts through LHSI’s use of the application’s search feature. Since all searches are saved by default, with just a few mouse clicks the company can quickly get the information it needs to fill out site questionnaires for clients, which is the information they need in order to award LHSI with its latest study. After the study is awarded, the company can use the same saved search to identify and reach out to potential participants who are already prequalified. Also, in addition to improved reporting functionality and more efficient data collection, LHSI is realizing greater productivity. One example is the at-a-glance reports, which help monitor patient enrollment to inform or refocus recruitment efforts.

Overall, Reveal has provided multiple benefits to LHSI. Users can log in to one system to schedule their appointments, record completed visits, or download and print study documents. LHSI only has to set up a study once, regardless of how many sites are participating. Reveal even allows each site on the same study to have different budgets.

About The Authors
Alec Fishburne is VP of operations at StudyManager and has worked with numerous research organizations as a business process consultant, project manager, and software developer.

Malia McFatridge is senior project manager at StudyManager. Previously she worked at a clinical research site in Honolulu for eight years, with experience working in the lab, with regulatory submissions, and as a coordinator.