Sapience Strategic Consulting

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With over 40 years of experience in managing and overseeing Independent Data Monitoring Committees (IDMCs) and Independent Adjudication Committees (IACs), Sapience Global Consulting is the industry’s authority for ensuring compliance, integrity, and operational excellence across global clinical trial review processes.

For Sponsors Running Their Own Committees

Running an IDMC or IAC internally can be effective, but only if the controls, governance, and documentation can withstand an FDA or EMA inspection.

Strategic Consulting for Vendor Selection & Oversight (We do not run your IDMC or IAC.)

Sapience helps sponsors design, validate, and operate compliant internal oversight models with full independence proof. We can ensure your vendors are doing the same.

Sapience deliverables for the sponsor internal committee setup or for vendor oversight:

• Firewall Architecture Blueprint—that defines who can access unblinded data, who cannot, and how access is logged via data transfer agreements (specifications).
• Role Mapping & RACI Matrices—establishes “Organizational Firewalls” between the sponsor's internal functional areas.
• Charter & SOP Harmonization—ensures independence is encoded in both documents.
• Charter & Protocol Harmonization—ensures the charter aligns with the study protocol.
• Charter design: Charter drafting and gap analysis. “Less is more” sections, region-specific clauses, member/chair/biostats roles and interplay, and rules for IDMC and IAC interaction.
• Set up project management: timeline, templates, RACI, data handoffs, and readiness gates.
• Performance oversight: KPI design (packet accuracy, schedule adherence, decision clarity), governance cadence, scorecards.
• Mock Readiness Audit—simulate auditing questions on IDMC/IAC operations, data separation, and independence validation.
• Outsourcing your IDMC/IAC? We can assist with vendor selection: qualification criteria, scoring rubrics, RFP questions, and reference checks specific to IDMC/IAC.

Outcomes:

• Inspection-ready evidence of functional independence.
• Reduced risk of findings or data invalidation.
• Demonstrated due diligence that satisfies both FDA and EMA scrutiny.
• Avoid time-and-materials sprawl via SLA-anchored KPIs.
• Fewer change orders through clear charter & data rules.
• Better sponsor/vendor relationship with measurable expectations.

With decades of experience and a global regulatory perspective, our services are designed to instill confidence, mitigate risk, and streamline committee governance so you can focus on the science and the data.

*Committee Performance Benchmarking & Rescue Remediation
This service includes baseline audit → KPI dashboard → benchmarking vs industry → remediation plan for underperforming committees (internal or vendor-run). 

Did You Know?

Regulators no longer accept “intent of independence”; they require proof.  If your IDMC or IAC operates under your sponsorship, you must validate and audit it or face inspection findings that could jeopardize the credibility of your submission.