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A worldwide leading technology medical device company was expanding the use of their number one medical device to new therapeutic areas. It counts over 1,670 surgical systems installed in over 1,500 hospitals. This post-marketing study was key to show how their surgical robot could benefit other types of surgery. The sponsor was looking for a way to efficiently manage such large amounts of data while staying on time and on budget.
The FDA had mandated the sponsor to conduct studies for each surgery type assessing the safety and efficacy of the robot attachments. This included prostatectomy, hysterectomy, nephrectomy, thyroidectomy, mastectomy, pelvic reconstruction and hernia repair. As a result, the sponsor was looking for a cost-efficient EDC platform that they could leverage to host the different studies.
Clinovo provided on-time database build and edit check implementation using ClinCapture, a fully validated and customizable open source EDC system with no license fee. Our technology edge and process-oriented approach facilitated timely deliverables and significant cost savings. We built and validated the production database in just 7 weeks. We saved our client over 50% in EDC implementation costs compared to proprietary systems. Moreover, we trained the sponsor’s staff to build studies, which enabled them to customize and roll out themselves the ClinCapture platform for more than 15 additional studies. In addition, our client was able to host the system, thus avoiding vendor lock-in and keeping full control over their clinical data. This approach allowed the sponsor to significantly reduce the overall cost of this post-marketing study.
Unmatched cost-efficiency: 50% implementation cost saved and split in 10 studies
System stability to manage the 9 studies that included large amounts of patient data
An intuitive system to enable the 6 site administrators to quickly learn how to use the system and enter patient data
“Clinovo was able to leverage their know-how in open source EDC to deliver a cost-efficient solution tailored to our specific needs.”
Director of Clinical Affairs, Intuitive Surgical