Integrity in the governance of human research.
+Schedule a ConsultationAvailable for strategic consulting, fractional advisory, and interim regulatory leadership engagements supporting drug, biologic, and device programs navigating FDA-regulated research oversight, IRB submission strategy, inspection readiness, vendor qualification, and research compliance infrastructure. Advisory capability is grounded in direct experience across sponsor, CRO, site monitoring, and central IRB governance, informed by a clinical operations background. Providing perspective that is particularly relevant to commercial and growth-stage research organizations seeking stronger governance, operational discipline, and more effective navigation of IRB and regulatory expectations. Engagements include protocol advisory and pre-submission review, IRB stipulation and deferral response strategy, and regulatory and clinical operations strategy.
Core Disciplines
Protocol Advisory & Pre-Submission Review
IRB chair-level review of protocols, investigator brochures, and informed consent documents before submission. Identifying inclusion and exclusion criteria concerns, risk-benefit framing, procedural gaps, and consent language that would likely surface as committee stipulations or deferrals, with revisions grounded in the regulatory basis of the review.
IRB Stipulation & Deferral Response
Drafting responses and protocol or consent revisions that address the regulatory basis of the determination, not just the surface language of the stipulation. Preparing submission packages that anticipate committee concerns, reduce revision cycles, and shorten time to approval across drug, biologic, and device programs.
Fractional Regulatory Leadership
Interim and advisory leadership across IRB operations, Human Research Protection Programs, and sponsor or CRO regulatory functions. Supporting submission strategy, committee interface, reviewer governance, and SOP development without the cost of a full-time executive hire.
Inspection Readiness & Regulatory Interface
Preparation for FDA BIMO inspections, AAHRPP site visits, and sponsor audits, with focus on consent documentation, deviation reporting chains, reportable events, and the integrity of the regulatory record. Serving as the interface between sponsor, site, and committee during inspection response and corrective action planning.
Advisory shaped to the organization, not the other way around.
Sponsors & Biotech Companies
Providing chair-level perspective before submission, helping sponsors anticipate committee concerns, reduce deferrals, and resolve IRB stipulations efficiently. Advisory covers protocol review, risk-benefit framing, consent defensibility, and regulatory strategy support for IND and IDE programs across drug, biologic, and device development.
Contract Research Organizations & Site Management Organizations (SMO)
Supporting CROs and SMOs managing multi-site submissions, IRB stipulations, and regulatory strategy with response drafting, submission review, and leadership counsel. Support includes CRO governance, vendor qualification, transfer of regulatory obligations, and reviewer-facing submission quality for organizations scaling oversight infrastructure.
Research Sites & Academic Medical Centers
Assisting sites and academic centers with central IRB reliance, consent compliance, deviation reporting, and IRB stipulation responses. This includes SOP and quality systems development, research compliance infrastructure, and preparation for FDA BIMO, AAHRPP, and sponsor audits.
Investigators
Providing chair-level perspective to individual investigators, with guidance on IRB stipulations, deferral responses, and the regulatory interface between sponsor and committee requirements. Support is grounded in human subject protections, informed consent and risk-benefit review, and direct experience navigating the sponsor-site-IRB relationship.
Where advisory capability is applied.
Research Oversight
- FDA-regulated research oversight
- IRB submission strategy
- Inspection readiness
- Human subject protections
- Informed consent and risk-benefit review
Governance & Infrastructure
- SOP and quality systems development
- Research compliance infrastructure
- CRO governance and vendor qualification
- Reviewer-facing submission quality
- Board governance and reviewer infrastructure
Regulatory Strategy
- Pre-submission protocol review
- IRB stipulation and deferral response
- Regulatory strategy for IND and IDE programs
- Sponsor, CRO, and site regulatory interface
- FDA, AAHRPP, and sponsor audit representation
This perspective is particularly applicable to commercial, private equity-backed, and growth-stage research organizations seeking stronger governance, operational discipline, and more effective navigation of IRB and regulatory expectations.
Active Commercial Central IRB executive authority. Cross-functional experience across every function in the company and research enterprise.
Serving as Commercial Central IRB Chair of Univo IRB, an AAHRPP-accredited commercial central IRB, and as a Fellow of the Harvard Medical School Center for Bioethics. Glenwood Ethical Research Advisory was founded to make senior-level IRB and regulatory counsel available to sponsors, CROs, sites, and investigators who need more than a compliance checklist.
He has spent more than 20 years across sponsor, CRO, site, monitoring, and IRB executive functions, including six years as a non-affiliated scientific board member at Advarra IRB. His credentials include an MS in Clinical Research, an MBA, and ACRP certifications as a Certified Project Manager, Certified Medical Device Professional, and Certified Clinical Research Associate. He is also a registered nurse with a background in neonatal critical care and emergency medicine, grounding human subject protection review in direct clinical experience.
Engagement options that match the situation.
Project-Based Engagements
Most engagements begin with a defined scope and a clear deliverable: a pre-submission protocol review, a stipulation response package, an inspection readiness assessment, or a regulatory interface memo. Project-based work is scoped in a written engagement letter, priced on a fixed-fee or hourly basis depending on the nature of the work, and delivered within an agreed timeline. There are no retainer minimums for project work.
Fractional & Ongoing Advisory
Organizations that need sustained IRB or regulatory advisory presence without a full-time hire can engage on a fractional basis. Fractional engagements are structured with a defined scope of involvement, a regular cadence, and transparent value-based pricing. They are designed to integrate with the organization's existing operations rather than operate as a parallel structure.
Rapid-Response Support
Some situations do not fit a standard project timeline. A deferral letter arrives with a response window. An inspection notice is received. A significant protocol amendment generates unexpected IRB concern. Rapid-response engagements can be arranged at the time of inquiry.