BEFORE
Coastal Pediatric Research Before RealTime
- Slow, paper-based system
- Frequent duplicate tasks
- Lacking accessibility for documents
AFTER
Coastal Pediatric Research After RealTime
- Fast, fully digital system
- No duplicate tasks
- Full accessibility anytime, anywhere
Overview
Based in Charleston, SC, Coastal Pediatric Research started in the spring of 2012 as an extension of Coastal Pediatric Associates. Their research enterprise has grown into a multi-specialty, diverse pediatric research program within the private practice setting.
Coastal Pediatric Research has been involved with over 100 clinical trials in all phases of clinical research that include vaccine, pharmacologic, device, and observational studies.
The Challenge
Coastal Pediatric Research had considered implementing an eRegulatory solution for quite some time. They seriously questioned if it would just be a shiny new IT system to show sponsors to appear progressive, or if it could be an extremely beneficial investment for their organization.
They asked their clinical research associates (CRAs) for feedback: Would they be open to using the system at their site? Would it make site visits more productive in terms of previewing the patient data versus the regulatory piece? Would it make their own work any easier?
“Our sponsor, CRO, and CRAs were more open to the possibility than we had anticipated,” said Julia Brenner, MHA, Finance and Regulatory Manager for Coastal Pediatric Research. “That was really the trigger for us to move forward with an eRegulatory solution.”
The Solution
First, Coastal Pediatric Research outlined what they wanted an eRegulatory system to provide, which included 21 CFR Part 11 compliance, a user-friendly interface, regulatory binder structure flexibility, the elimination of duplicate work, the ability to streamline signatures, and an integration with their clinical trial management system (CTMS). After seeing a demo, Coastal Pediatric Research was confident the RealTime-Complion eRegulatory solution would meet all their requirements.
During implementation, Coastal Pediatric Research had to take a good look at their current processes and determine how to make improvements. They began by setting up strategic goals for timelines and document completion. They discovered they were investing a great deal of time keeping track of when GCPs and CVs of investigators and site staff would expire. As their organization grew larger and the number of studies they were conducting increased, it was evident that someone’s CV or GCP training would expire before they had ample time to renew.
“We set up a report in Complion to help the credentialing department see the status of CVs, medical licenses, or GCP training. The department now has enough visibility to begin reminders well before expirations occurred,” explained Brenner.
Training was another early hurdle. Complion’s easy-to-use system helped, as did the ample support materials supplied. “They provided us with language for our SOPs that made the onboarding process much simpler. Further, they provided several valuable resources like a sponsor success letter, contract language, and budget negotiation tips for getting the system covered. We really didn’t think a vendor would offer these resources,” said Brenner. “It’s something Complion automatically provided. It confirmed we had chosen the right vendor for our eRegulatory system.”
As more staff were trained on Complion, the time savings and improved workflows became evident across the entire organization.
“With Complion, our coordinators achieved a 40% reduction in time spent on regulatory document management – time that can now be spent on recruitment and patient visits.”
Julia Brenner, MHA, Finance and Regulatory Manager
Coastal Pediatric Research
The Results
With Complion’s eRegulatory solution, Coastal Pediatric Research has not only increased their efficiency, but has also greatly improved their time management and eliminated duplicate work. As a large pediatric group with several research sites, it would often take as long as 5 days to gather the required signatures for a given document. They set a goal of 48 hours to collect them, and several months after implementation, they are now within that time frame.
According to Brenner, “If you ever question if you’ve made the right decision moving forward with an eRegulatory system, just take a look at the reduction in hours and how satisfied the staff is because their work is now so much easier.”
- Key Takeaways
With RealTime-Complion, Coastal Pediatric Research increased their efficiency by improving time management and eliminating duplicate work. Other benefits include:
- Accurate signoff
- Faster inspection and audit readiness
- Direct document access
- Faster study start-up
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