Falling Behind: The Consequences of Ignoring Innovation in Clinical Compliance In an era where technology is evolving at lightning speed, innovation in clinical compliance innovation is no longer optional — it’s essential. Tools like artificial intelligence (AI), machine learning (ML), and intelligent automation are rapidly transforming how we manage compliance activities, oversee the Trial Master […]
Month: April 2025
ICH E6(R3) Sponsor Oversight
ICH E6(R3) Sponsor Oversight: What Clinical Compliance Teams Must Know With ICH E6(R3) taking effect this July, clinical research sponsors face a new mandate: move beyond passive documentation and adopt a more proactive, risk-based approach to oversight. The latest guidance signals a shift—sponsor oversight must be continuous, data-driven, and directly linked to risk management and […]
Future-Ready Clinical Compliance
Future-Ready Clinical Compliance Start the Conversation About Innovation Now AI and other next-generation technologies are poised to reshape clinical research as we know it—especially in how we manage clinical data, operations, and compliance. What’s coming isn’t just incremental improvement—it’s transformational. From automated Trial Master File (TMF) oversight to intelligent quality monitoring, these innovations will streamline […]