SME_Clinical_Vendor_Oversight

SME Clinical Vendor Oversight & Compliance Toolkit

Over the past year, there have been many buzzwords thrown around the industry: ICH GCP E6 (R2) addendum, risk-based approach, vendor oversight, data anonymization, GDPR. What makes SME clinical vendor oversight a particular challenge? Recent industry changes can be summed up into one general concept: regulatory authorities and international standards are cracking down on data…