
True committee independence is achieved not by promise but by process.
To be the gold standard for IDMC and IAC compliance, training, and consulting, enabling better scientific oversight.
Integrity: We maintain independence and objectivity in every audit, training, and consulting engagement.
Excellence: Decades of experience enable us to set and continually raise performance benchmarks.
Global Mindset: We understand regulatory nuance across the U.S., EU, UK, and JAPAC regions.
Innovation: We stay ahead of emerging trends, including AI, digital trials, and remote governance.
Partnership: We work with you as trusted advisors, not just vendors.
At Sapience Global Consulting, we are not only leaders in Independent Data Monitoring Committee (IDMC/DMC) and Independent Adjudication Committee (IAC/EAC) operations but also in providing expert guidance on these committees. We are recognized for our client-centric approach, developing audit-ready governance, modern oversight charters, and inspection-proof workflows that safeguard patients and mitigate risk in submissions. We follow project management standards (PMP), maintain ISO quality mindset, and utilize technology-enabled solutions (21 CFR Part 11 systems, analytics-driven KPIs) to ensure predictable timelines, transparent
decision-making, and regulator-ready documentation across complex, multi-region studies.
Sapience reviews operations, the systems, documentation, and evidence that make independence provable.
For Sponsors
Protect your study’s integrity and reputation with independent expert oversight. Our audits and training ensure your committees meet every regulatory and ethical expectation, reducing inspection risk and maintaining confidence in your data.
For CROs
Allows you to strengthen excellence and regulatory readiness for sponsors. Our audits and training programs help your teams strengthen the internal quality system and maintain full compliance across global markets.
For Auditing Companies
Expand your service offerings by partnering with the industry’s DMC/EAC experts. We provide audits, training, and SME support for your inspection preparation or client consulting projects.
Why Our Experience Matters:
With more than four decades of hands-on work in IDMC/IAC operations, we’ve seen what works and, more importantly, what fails. We bring that insight to your committees, training, vendor oversight, and strategic consulting, so you don’t just comply, you perform.
40+ years of experience equals in-depth expertise built from managing and auditing IDMCs and IACs across all major therapeutic areas and regulatory regions.
Global regulatory alignment for the U.S. FDA, EMA, MHRA, and PMDA audit readiness is built into every service.
Independent oversight for objective, third-party verification that adds credibility and transparency.
Committee member and sponsor-centric training with tailored programs created by subject matter experts who have led and managed DMCs/EACs directly.
Planning for the future, training modules that cover the latest applications of AI and data analytics in committee operations.
End-to-end quality assurance, from vendor selection to inspection preparation, with every service reinforcing data integrity and compliance.
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