Andy Murillo // SST
How Spinal Stabilization Technologies uses the UNITY platform as a clinical data management software to conduct four clinical trials across six countries
Challenge
Conducting global clinical trials while delivering sites best-in-class site clinical data management software.
Solution
SST uses the UNITY platform to give sites an intuitive way to collect PROMs, eCRFs, and imaging data.
Outcome
Using RAYLYTIC’s technologies, SST has been able to launch 4 clinical trials across 6 countries.
Excerpt
Spinal Stabilization Technologies (SST) is a fast-paced developer of spinal medical devices. Using the UNITY platform, they have been able to set up and conduct four clinical trials across six countries, provide sites with access to best-in-class site technology and gain exceptional insights into the efficacy and performance of their spinal implants.
Challenge: Clinical trials continents away
When oceans stand between sponsors, sites, and CROs, enabling stakeholders with best-in-class technology isn’t only beneficial – it’s vital.
Spinal Stabilization Technologies (SST), a developer of spinal medical devices, experienced this firsthand when they began planning clinical trials in Europe and South America for their PerQdisc Nucleus Replacement System.
“In the beginning, coordinating with clinical sites and our CROs as well as collecting the diverse data we needed had the potential to be overwhelming,” Andy Murillo, clinical specialist from SST, recounted.
Best-in-class clinical data management software for complex trial designs
Murillo and SST were indeed dealing with a lot of complexity. This included:
- Managing intricate, multi-center study designs
- Collecting patient-reported outcome measures (PROMs) and medical imaging data as endpoints
- Providing CROs and sites with technology that could slot seamlessly into established workflows and simplify gathering high-quality data.
- Partnering with an experienced imaging core lab for centralized analysis of imaging data for example for range of motion, disc height, and center of rotation.
With all this awaiting them, SST couldn’t afford to juggle multiple solutions.
“As a fast-paced developer of spinal implants, it was imperative for us to choose software vendors that match our agility.”
– Andy Murillo, Spinal Stabilization Technologies
Finding an all-in-one clinical trial management platform was therefore paramount. It had to establish remote links between all trial stakeholders: patients, medical reviewers, principal investigators, data monitors, and imaging core lab — with no sacrifices to user experience and data security.
Solution: UNITY Platform as a clinical data management software
To present sites with an attractive, easy-to-use solution and conduct their trials with efficiency and transparency, SST decided on the platform from RAYLYTIC.
Site- and CRO-friendly features
The platform met the requirements of the CROs and sites with respect to the following features:
- Options for remote monitoring
- Straightforward resolution of queries
- Automated edit checks
- ISO 27001-compliant information security processes
Since starting the trials, it has given them a centralized location for all their data, documents, and permissions; and has helped them to be prepared for upcoming deadlines. Plus, it has alleviated them from redundant and error-prone data entry tasks.
“Our CROs and principal investigators have been extremely impressed with the quality of data coming out of sites and their interactions with RAYLYTIC,” Murillo said.
The following features have also played a role in the success of SST’s clinical trials.
Self-contained image collection and analysis
Imaging endpoints are notorious for requiring separate solutions and draining back-and-forth communication with imaging core labs.
SST, however, has found it’s integrated imaging data management module to be a game changer. It provides a centralized and standardized way for storing, deidentifying, uploading, classifying, and reviewing imaging data.
This has dramatically reduced the time and resources SST expends for collecting and managing their images.
For example, sites can upload images per drag and drop. They do not have to fear uploading duplicate or erroneous DICOM files thanks to the platform’s integrated quality controls. Medical reviewers can also use the integrated DICOM viewer to review cases. RAYLYTIC’s imaging core lab then conducts centralized image analysis and provides regular reports on outcomes and data completeness to SST.
And when questions or queries do arise, SST as well as sites and CROs can rely on the attentiveness, responsiveness, and expertise in orthopedic clinical trials from RAYLYTIC.
User-friendliness
Outfitting sites and CROs with easy-to-use technology can significantly impact the success of a study. More and more, sites are wishing for solutions that enable them to retain their established workflows.
And with the UNITY platform, SST has achieved exactly that. “The sites and CROs involved in the trials are so relieved to finally have a platform that automates redundant tasks and ensures highest quality data with little extra effort,” Murillo explained.
Outcomes
4 clinical trials, 6 countries
With the support by RAYLYTIC, SST has launched four separate clinical trials with sites in six different countries.
These include their Nucleus 181 clinical trial, which took place in Europe and Canada, and concluded in mid-2022. Furthermore, SST now has three “Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nuclectomy” (LOPAIN) studies in various stages of completion.
Along the way, they have witnessed the considerable difference site-friendly technology can make on the quality of data and smoothness of their studies.