Regulatory Forces Drive The Need For Advanced Planning In Study Initiation

By Craig Morgan, Head of Marketing, Study Startup, Oracle Health Sciences

Recent regulatory changes establish the need for advanced study planning, aligned study startup management, and cross functional coordination. ICH E8 (R1) and E6 (R3) guidelines will result in a fundamental shift in how all clinical trial regulations are written. Today, regulations are prescriptive and often country-specific, which limits flexibility to implement innovative study designs (e.g., decentralized trials), and often present ambiguities for implementing global studies. Revisions for the ICH E6 (R3) revision are fast approaching, and these guidance’s reconfirm the importance of strategic alignment of eClinical technologies, which ultimately will result in more cost-effective treatment options for patients.

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