By Alec Fishburne   

March 23, 2012 | Guest Commentary | It’s no secret that the clinical trial environment is changing, with the constant need to increase efficiencies and overall performance while reducing costs. However, it’s worth noting that there are sites successfully implementing strategies to meet these demands through the implementation of clinical trial management systems.  

The Lynn Health Science Institute (LHSI) is one such site. As an emerging leader bringing new drugs to market through its clinical trials program, LHSI has completed over 300 clinical trials, working with over 200 pharmaceutical companies and CROs.    

As a busy, growing research organization with multiple site locations, LHSI needed to improve how it managed the dozens of clinical trials its sites could be conducting at a given time. They previously relied on data collected in spreadsheets and a time-consuming process to produce reports from those spreadsheets. In fact, the entire process was so time-consuming, it could only be undertaken once a month. Needing a better solution, LHSI implemented a clinical trial management system (CTMS) to manage its clinical studies, and have reported a variety of business benefits, including:  

Real-time monitoring of metrics critical in achieving revenue goals   

The ability to measure revenue in real-time is critical to any business, as a current revenue position is essential in understanding progress made towards revenue targets. Previously, LHSI only had 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. Having implemented the CTMS, LHSI now can monitor benchmarks and look ahead at what they could anticipate in terms of patients and appointments. The system automates most of this process, so instead of a collection of workbooks and worksheets, all of the studies and patients are now in one central system, without the need to merge various files together in order to create reports. Operational and financial planning is much more well-informed and effective now, since LHSI can proactively assess their status as they relate to business goals.   

Faster payment processing and fewer manual steps  

At any point in time, LHSI may be involved in dozens of clinical trials, which made generating reports a labor-intensive process. Now, LHSI has cut reporting times down from a week-long process to just a few hours. They no longer spend as much time trying to collect the information, and coordinators can quickly record the required information, spending less time on data entry and devoting more time toward making each study a success. As a result of this time savings, LHSI reports that its productivity has improved dramatically.  

Using a CTMS has also helped LHSI reduce time spent on payables, taking what was previously a week-long process down to 4-6 hours.  

Ability to meet regulatory requirements  

As we are all aware, meeting regulatory requirements is an ongoing challenge. By centralizing management of study files, LHSI is meeting regulatory requirements by ensuring that the most recent, approved documents are available to users.  

Enhanced business development efforts, greater recruiting productivity  

LHSI has enhanced business development efforts by taking advantage of advanced search capabilities to better identify—and reach out to—potential participants who are already pre-qualified, ensuring that recruitment efforts are targeted and effective—a big advantage when enrollment is competitive among all of the study’s other research sites.   

Interface helps user adoption, even for multisite studies  

LHSI’s users can now log into one system to schedule their appointments, record completed visits, or download and print study documents. They only need to set up a study once, regardless of how many sites are participating. Additionally, using the system administration functionality, they can restrict user access permissions on a user-by-user basis via security settings, while at the same time expanding the CTMS system’s benefits organization-wide since there are no limits to the number of user accounts that can be added.  

Summed up, LHSI has shared that leaving behind spreadsheet-based tracking and reporting for a more centralized and efficient environment solution has provided an incredible benefit to the entire operation. They now have real-time monitoring of metrics which are critical in helping them achieve revenue goals and have faster payment processing times with more streamlined data collection and reporting. They’ve also been able to enhance business development for greater recruiting productivity and a growth in business.  

We know through our discussions with sites across the country that many still are fighting to get by while using paper-based spreadsheets to manage clinical trials. We hope that by sharing lessons learned by other organizations, sites will see the benefits of investing in technology to help improve operations and boost their bottom lines.  

Alec Fishburne is a vice president at StudyManager, Inc., a provider of EDC and CTMS solutions.