A medical device study was facing significant site-level execution issues, including GCP and protocol compliance gaps, incomplete data capture, poor communication, training deficiencies, and operational challenges. With a target enrollment of 2,000 participants, the sponsor needed experienced intervention to stabilize the site and restore the study to track.
InoRx deployed experienced project management and clinical research leadership to assess the site and develop a targeted action plan. The team strengthened GCP and protocol training, improved data-entry and monitoring practices, coordinated vendors and supplies, streamlined Ethics Committee communication, and strengthened collaboration between the site, sponsor, and project team.
The intervention resolved longstanding operational issues and returned the study to on-track execution. Staff capabilities, data quality, communication, vendor support, and overall site operations improved, enabling a smooth transition to participant recruitment toward the 2,000-participant target.
A Case Study in Hands-On Site Intervention and Operational Recovery
A non-invasive medical device study using pulse CO-oximetry (Spot Check SpHb) in adult, pediatric, and pregnant participants was experiencing significant execution challenges at the site level.
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