Clinovo Case Study: Open Source EDC Unmatched Cost-Efficiency

BACKGROUND | 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.

CHALLENGES | 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...