Investigator sites provide an essential connection between drug development sponsors and patients in clinical trials—and play a key role in producing high-quality data. To better support a site’s day-to-day study activities and make a difference for patient care, Labcorp Central Laboratory Services (CLS) is continually evaluating current practices and implementing ongoing process improvements.
We spoke with Vidya Navile, Associate Director, Head of Global Investigator Services, Investigator Training Center and Site Communications, to learn about the latest initiative to enhance the overall investigator site experience with electronic query notification and resolution, called eQuery.
Recognizing an opportunity to streamline site operations
Discrepancy management, also known as query management, is a standard part of laboratory information management to ensure that all data are correct and complete. At the investigator site, resolving missing or discrepant specimen information is necessary to generate high-quality data for clinical trials. Many test results cannot be released until queries are resolved.
“Our former process for query notification was an extensively laborious manual process,” said Navile. “It was dependent on the individual coordinator, so there were inefficiencies in the process.”
To create a faster, more convenient way to communicate and resolve queries, four teams at Labcorp CLS worked together to enhance the site experience and enable success with new automated capabilities.
Understanding sites’ needs and creating a consistent, automated process
Leveraging the technology platform of Xcellerate® Lab Investigator Portal, which provides secure and easy access to laboratory data, study documents and test results, the Labcorp CLS teams evaluated how they could deliver more efficiencies to sites and strengthen the accountability between sites and the lab.
Based on feedback from sites, Labcorp created a configurable email notification that is sent to the sites to highlight any new queries, which are now posted in Xcellerate Lab Investigator Portal. The sites can simply log into the portal to view the details. Investigator sites can now respond to queries directly within the portal.
To streamline the resolution of unanswered queries and provide clear communications, an escalation process has also been included in the eQuery design.
In the escalation process, if there has been no response to a query, an automated email is sent to the site. After each 24-hour period with no response, the escalation path continues up the chain of command—first to the clinical research associate, then the Labcorp regional study coordinator and finally the Labcorp global study manager. Each party is notified by email, instead of phone or fax, which helps standardize the way escalations are received and resolved.
“We’re trying to eliminate inefficiencies for the sites. All the queries are in Xcellerate Lab Investigator Portal,” explained Navile. “If a coordinator is out of the office, the site is no longer dependent on one person to help resolve a query. Now, the entire department can be accountable. It’s a very effective method for the site.”
eQuery: 5 Key Takeaways
- Eliminates manual processes in query management of missing or discrepant specimen information
- Integrates query notification and resolution into Xcellerate® Laboratory Investigator Portal
- Streamlines and standardizes the notification and escalation processes
- Promotes faster resolution of queries and the subsequent release of test results
- Improves study transparency for sponsors with the new eQuery Summary Report
Enhancing study transparency for sponsors
Electronic query functionality has also been added to Xcellerate Lab Sponsor Portal. Sponsors can view a summary report of queries for their study by site as well as view the age and status of each query. This eQuery summary report enhances transparency for sponsors while maintaining any necessary blinding for the study.
“Sponsors have been extremely interested in this functionality,” said Navile. “We’re giving them a standardized way of approaching the information, but from a lab results perspective.”
With a consistent process for query notification and escalation in one consolidated platform with study documents and test results, eQuery reduces manual processes, delivering more convenience to sites and enforcing more consistent processes.
We believe this initiative will ultimately promote faster resolution of queries and the subsequent release of test results. As we aim to be more than a partner to proactively meet the needs of both sites and sponsors, we will continue to identify process improvements and work with urgency to deliver answers that advance clinical trial testing and make a difference for patients.