Case Study: Leading Medical Technology Company achieves automated safety surveillance and reduced manual errors with ComplianceQuest

Raising Clinical Trial Safety Standards with Next-Gen Safety Management Solution

Leading Medical Technology Company, a 60-year-old American cardiovascular device manufacturer with more than 14,000 employees, faced constraints from conventional, manual safety-management and post‑marketing surveillance processes that increased time, cost, and error risk. ComplianceQuest (partnering with Cloudbyz) was engaged to modernize pharmacovigilance and clinical safety using CQ Clinical (powered by Cloudbyz) and the Cloudbyz Safety & Pharmacovigilance Management Solution.

ComplianceQuest deployed the Salesforce‑native CQ Clinical/Cloudbyz Safety Management Solution to automate adverse‑event tracking, notifications, patient and site management, EDC/eTMF integration, and regulatory reporting, and provided training for staff. The result was end‑to‑end automation of post‑marketing surveillance, dramatically reduced manual interventions and errors, automated consent and report generation (e.g., MDCG, DSMB), and faster, more compliant time‑to‑market.