NuVasive Streamlined Literature Reviews for More Efficient CER Submissions with DistillerSR
NuVasive, Inc. is the leader in spine technology innovation, with a mission to transform surgery, advance care, and change lives. The company’s less invasive, procedurally integrated surgical solutions are designed to deliver reproducible and clinically proven outcomes. NuVasive operates in more than 50 countries.
Consistent, Repeatable Processes
Audit-Ready CER Submissions
Always Available Data Company Wide
Process improvement is also part of her mandate. And that’s how DistillerSR came into play.
“I came across DistillerSR while I was doing research to apply for this job at NuVasive. It seemed like a platform that could truly streamline the collection and analysis of clinical data,” she noted.
That was in November 2018. She was hired in January 2019, and a few months into the job, it became clear that using Excel spreadsheets to conduct literature reviews manually was not sustainable. “The whole process was manual and inefficient,” Monique pointed out. “Relying on spreadsheets as the sole mechanism to track clinical evidence is error prone, not easily reproducible and inconsistent. In the back of my head, I knew DistillerSR would present us with scalable solution and a better path forward.”
“DistillerSR displays the pathway for the entire body of clinical evidence for each device. Everything is clearly documented for the clinical evaluation report (CER) submission,” stressed Monique. As a result of implementing DistillerSR, the team was able to successfully transition the process of collecting and analyzing clinical data from a contract research organization (CRO) to an in-house group.
All CER submissions are subject to tight deadlines, and time is critical for a team striving to get devices to the market safely for patients whose lives have been severely impacted by a spine- related disability or pathology.
“Some people would argue that using Excel spreadsheets to track the pathway for a clinical evaluation is sufficient,” Monique said “I would rather go into my DistillerSR projects to retrieve all the clinical evidence for each included study, export my data, and instantly produce a PRISMA diagram.”
Using DistillerSR’s Datarama, they are able to export data easily, build customized reports and select specific sets of references and data elements to be displayed. Reports can then be viewed in DistillerSR or downloaded as various file types.
The ability to keep stakeholders informed is also key for the NuVasive team. DistillerSR’s reporting functionality allows Monique and her team to do just that by scheduling automated email updates to ensure everyone is aware of their review projects’ progress.
The team has grown to six medical writers since implementing DistillerSR. “We have a running order that every new medical writer has to work in DistillerSR. In a way, they are born into a more efficient process.”
The whole process was manual and inefficient. Relying on spreadsheets as the sole mechanism to track clinical evidence is error prone, not easily reproducible and inconsistent. In the back of my head, I knew DistillerSR would present us with a scalable solution and a better path forward.
Distributed teams can collaborate more effectively and improve productivity using DistillerSR. Medical writers can rely on standard processes and reduce the overall administrative burden of literature reviews. Reviewers are automatically assigned
and notified of new work, regardless of the number of projects they are working on. Meanwhile, project managers can monitor progress in real-time and gain insight into the team’s workload, performance, and quality.
“With CuratorCR, I’ll know immediately if a colleague has already retrieved clinical data related to a particular device and won’t waste any time on that task. It will be a huge time saver for our team,” said Monique.
For Nuvasive, CuratorCR is expected to simplify the data collection process for monitoring similar competitive devices placed on the market, as part of the EU MDR post-market surveillance (PMS) requirements managed by the company.
Always Accessible Data
“The purpose of DistillerSR goes beyond simply conducting systematic literature reviews,” Monique noted. “I store everything in there — it’s become a living archive for my entire device portfolio. With every project, I have a snapshot in time I can refer back to. I can then look at the data and pivot as necessary for the next one.”
DistillerSR has become the fundamental first step of the process for all NuVasive’s CER submissions once establishing their search parameters.
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How to Address EU MDR Compliance Challenges With Automated Literature Reviews.
Automated literature reviews provide greater levels of auditability and program management to CER and PER submissions.
Dr. Bonnie H. Weiner describes the way DistillerSR reduced the time it took to complete CER literature reviews by approximately 30%.