Services

Advisory at the intersection of research ethics, regulation, and operations.

Available for strategic consulting, fractional advisory, and interim regulatory leadership engagements supporting sponsors, CROs, research sites, and growth-stage research organizations navigating FDA-regulated research oversight, IRB submission strategy, inspection readiness, vendor qualification, and research compliance infrastructure. Advisory capability is grounded in practice within a commercial central IRB environment and informed by more than 20 years across sponsor, CRO, site, monitoring, and IRB leadership functions.

Protocol Advisory & Pre-Submission Review

Sponsors and CROs often submit protocols with avoidable IRB concerns: incomplete consent elements, risk-benefit framing gaps, or vulnerable population issues. Glenwood reviews submissions at the chair level before they reach the committee, producing concrete revisions and remediation language. The result is a cleaner submission, fewer stipulations, and a shorter review cycle.

Outcomes

  • -Cleaner first submissions to central and local IRBs
  • -Risk-benefit and consent framing that holds up under committee review
  • -Fewer stipulations and a shorter review cycle

Key Deliverables

  • -Chair-level protocol review memo with prioritized findings and remediation language
  • -Consent and recruitment material review against 21 CFR Part 50
  • -Pre-submission risk register for vulnerable populations and equitable selection
  • -Board-presentation talking points for investigators and sponsors

Relevant Experience

  • -Executive IRB Chair at a PE-backed, AAHRPP-accredited commercial central IRB
  • -Harvard Medical School Center for Bioethics Fellowship
  • -20+ years across sponsor, CRO, site, monitoring, and IRB functions

IRB Stipulation & Deferral Response Strategy

IRB stipulations and deferrals are regulatory determinations that require substantive resolution. Glenwood works from the regulatory basis of each determination, not just its surface language, to draft responses and document revisions that close the issue at the root. This chair-level perspective reduces back-and-forth and shortens the path to approval.

Outcomes

  • -Faster path from stipulation to approval
  • -Response packages that address the underlying regulatory concern
  • -Reduced back-and-forth across review cycles

Key Deliverables

  • -Stipulation-to-response matrix mapping each finding to its regulatory basis
  • -Revised consent language and protocol amendment guidance
  • -Sponsor response letter drafted for regulatory defensibility
  • -Board presentation prep for continued review meetings

Relevant Experience

  • -Active IRB Executive Chair with current board deliberation authority
  • -Guided sponsors and research sites through complex deferral responses
  • -ACRP CPM, CMDP, and CCRA credentials grounding the clinical operations view

Fractional & Interim Regulatory Leadership

Glenwood provides embedded advisory leadership across IRB operations, human research protection programs, and regulatory functions. Engagements are scoped to the organization: interim executive chair coverage, reviewer infrastructure, board governance, or ongoing regulatory guidance. Each engagement is priced transparently and designed to transfer capability rather than create dependency.

Outcomes

  • -Coverage during leadership transitions or growth phases
  • -Governance, SOP, and reviewer-infrastructure improvements
  • -Capability transfer to the organization rather than dependency

Key Deliverables

  • -Interim executive IRB chair or regulatory officer coverage
  • -Reviewer infrastructure development and credentialing architecture
  • -Board governance and AAHRPP accreditation preparation support
  • -HRPP operating model and KPI framework

Relevant Experience

  • -Executive IRB Chair at a rapidly scaling central IRB
  • -Associate Director of Clinical Operations at AriBio USA
  • -MBA and MS in Clinical Research supporting operating-model decisions

Inspection Readiness & Regulatory Interface

FDA BIMO inspections, AAHRPP site visits, and sponsor audits test an organization's oversight infrastructure. Glenwood supports preparation across consent documentation, deviation reporting, IRB correspondence, and regulatory interface under 21 CFR Part 312 or Part 812. This work is grounded in direct experience leading organizational FDA inspection readiness activities and direct FDA regulatory interactions, including inspection closure without findings.

Outcomes

  • -Inspection readiness targeting closure without findings
  • -Deviation and reportable event reporting chains aligned with IRB records
  • -Regulatory binder and correspondence documentation aligned with committee files

Key Deliverables

  • -BIMO, AAHRPP, and sponsor audit readiness playbook
  • -Consent documentation compliance review for the enrolled population
  • -Unanticipated problem and reportable event reporting chain review
  • -Regulatory interface support under 21 CFR Part 312 or Part 812

Relevant Experience

  • -Led organizational FDA inspection readiness resulting in inspection closure without findings
  • -Represents an AAHRPP-accredited commercial IRB in FDA, AAHRPP, and sponsor audits
  • -Cross-functional background spanning sponsor, CRO, site, and IRB operations

CRO Governance & Vendor Qualification

Sponsors moving into pivotal trials need vendor infrastructure that will hold up under regulatory scrutiny. Advisory support covers CRO bid defenses, Phase 3 RFP generation, vendor negotiations across CMC, laboratory, and eCOA/ePRO functions, transfer of regulatory obligations, and clinical development operational planning. The work is informed by having led these activities independently on the sponsor side.

Outcomes

  • -Defensible CRO and vendor selection decisions
  • -Clear transfer of regulatory obligations across sponsor and vendor
  • -Operational plans that survive contact with study execution

Key Deliverables

  • -RFP generation and bid-defense preparation for CRO and specialty vendors
  • -Vendor qualification framework across CMC, laboratory, and eCOA/ePRO
  • -Transfer of regulatory obligations documentation and oversight plan
  • -Clinical development operational plan aligned to program milestones

Relevant Experience

  • -Independently led sponsor-side CRO qualification activities at AriBio USA
  • -Bid defenses, Phase 3 RFP generation, and vendor negotiations across core functions
  • -Associate Director of Clinical Operations with sponsor-side accountability

SOP, Quality Systems & IND / IDE Support

Governance quality is what an inspection reveals. Advisory support covers SOP and quality systems development, research compliance infrastructure, reviewer-facing submission quality, and regulatory strategy support for IND and IDE programs, with particular applicability to commercial, private equity-backed, and growth-stage organizations building durable operating discipline.

Outcomes

  • -Quality management infrastructure appropriate to organization scale
  • -Submission packages built for reviewer-facing clarity and defensibility
  • -Governance and KPI architecture that supports scaling operations

Key Deliverables

  • -SOP architecture and quality management system development
  • -IND and IDE submission strategy support under 21 CFR Part 312 or Part 812
  • -Reviewer-facing submission quality assessment and remediation
  • -KPI framework, board governance, and operating-model documentation

Relevant Experience

  • -Functional Owner of Board Service Delivery within a PE-backed commercial IRB
  • -Accountability across board governance, reviewer infrastructure, and KPI development
  • -MBA and MS in Clinical Research supporting operating-model and quality decisions

Discuss an engagement scoped to your protocol, program, or IRB.

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