Who is Sapience Global Consulting?

---

With over 40 years of experience in the administration, auditing, and training of Independent Data Monitoring Committees (IDMCs) and Independent Adjudication Committees (IACs), we are the independent experts you can trust. From audit readiness to committee training to strategic consulting, our global team ensures compliance and excellence across the U.S., EU, UK, and JAPAC regions.

Our Value:

• Independent vendor auditing of IDMC and IAC operations, ensuring complete regulatory alignment (FDA, EMA, MHRA, PMDA)
• Physician-centric development for committee members and chairs
• Training programs for sponsors, CROs, and GXP auditors
• Strategic consulting for vendor selection, setup management, and performance oversight
• Trusted partner with decades of experience 

Oversight that regulators trust to protect sponsors, CROs, and internal committees from compliance risks.

Common issues:

• Inconsistent or vague charters create ambiguity regarding independence, quorum, and rules for closed and open sessions. Leads to rework and inspection findings.
• Weak or missing documentation (minutes, decision letters, data transfer records, audit trails) undermines inspection readiness. Threatens data integrity.
• Vendor drift SOPs often diverge from charters and KPIs. Issues are visible only at audit time and may sometimes result in CAPA finding(s).
• Underprepared committee members may slow down decision-making or risk inadvertently unblinding.
• Most GxP/GCP auditors are unaware of the details of how an IDMC or IAC operates and do not examine the underlying aspects, which may raise concerns or questions later when submitting for approval.

What You Gain:

• Audit‑ready governance aligned to FDA/EMA/MHRA/PMDA expectations.
• Faster, cleaner decision cycles with repeatable meeting workflows.
• Measurable vendor performance with KPIs tied to deliverables.
• Physicians and chairs who are ‘committee‑ready’ and confident in their responsibilities.

Oversight that regulators trust to protect sponsors from compliance risk.

Running your own IDMC or IAC makes you responsible for proving independence, not merely claiming it. Sapience validates your operations, firewalls, data segregation, and evidence trail.

Many sponsors are now choosing to manage their own IDMCs and IACs to retain control, shorten timelines, and lower costs.  But with that decision comes a non-delegable regulatory burden: proving that your internal committee is functionally independent with documented firewalls between operational data, sponsor personnel, and committee members. Without validated separation, even the appearance of influence can raise severe inspection findings.

At Sapience Global Consulting, we bring over 40 years of IDMC/IAC oversight experience to help sponsors safeguard integrity through independent audits, firewall design, and verification of process controls that demonstrate compliance with the expectations of the FDA, EMA, MHRA, and PMDA.

In today’s complex regulatory environment, independent committees are under increasing scrutiny. Whether you’re a sponsor, CRO, or auditing firm, you need oversight that goes beyond the checklist. Our deep experience in IDMC/IAC operations enables us to understand the challenges and provide pragmatic, practical solutions.

Sapience’s Strategic Advantages

Sapience Global Consulting is dedicated exclusively to auditing and validating IDMC and IAC operations as regulators tighten independence requirements and sponsors seek to demonstrate due diligence. This ensures that the vendors and sponsors who manage these committees meet global regulatory standards for independence, data segregation, and documentation integrity.

• Experience: Our team has over 40 years of combined experience in successfully administering IDMCs and IACs for both sponsors and CROs. 
• Vendor oversight vs vendor management: Many competitors provide complete administration (running the IDMC/IAC). We focus on auditing and consulting to assist vendors.
• Independence: We don’t run committees; we ensure those who do meet compliance. 
• Cross-vendor visibility: We can benchmark vendors objectively with no conflict of interest.
• Regulatory readiness for internal models: Sponsors who run their own committees require documented proof of independence. Our service is the new standard for such sponsor-managed committees.
• Data Governance & Cybersecurity for Committees: With remote meetings and digital data packets on the rise, committee data flows are increasingly vulnerable. Emphasizing audit of data security, encryption, access logs, and vendor cloud systems. 
• Hybrid/Virtual Committee Operational Best Practices: As trials transition to a global and virtual landscape, committee models evolve; we audit remote/hybrid meeting governance, IDMC/IAC execution, digital packet logistics, remote vote capture, and unintended unblinding risks in virtual settings.
• Global regulatory fluency: We align our audits with the FDA's 2024, EMA's 2020, and MHRA's 2023 guidances.
• Specialized training: We offer courses for both operational teams and physicians/chairs.
• Future-proof expertise: We plan to establish training programs for committees on AI and digital oversight, focusing on learning and addressing key challenges.

Why This Gap Exists

• Perceived conflict: Vendors who run IDMC/IACs can’t credibly audit competitors or themselves.
• Specialization barrier: True IDMC/IAC auditing requires deep procedural, biostatistical, and regulatory insight; most QA auditors lack that background.
• Regulatory evolution: The FDA/EMA/MHRA have only recently emphasized the importance of independence validation and firewall evidence; however, the market has not yet caught up.

Auditing & Compliance Assurance (for Sponsor, CRO, GxP, and Other Research Service Vendors)

Role-based Training:

• Sponsor, CRO, GXP Auditors Training 
• Committee-centric development for IDMC and IAC committee members and chairs.

Strategic Consulting

• Running an IDMC or IAC internally can be effective, but only if the controls, governance, and documentation can withstand an inspection by the FDA or EMA.
• Sapience helps sponsors or their vendors to design and validate operationally compliant internal oversight models with complete proof of independence.
• Sapience can assist with vendor qualifications to ensure the correct scope and setup from the outset.
• Consult on IAC planning and project manage implementation.

Discover how we can elevate your committee governance.