Senior Biobanking Consulting Across Research, Clinical, and Commercial Settings
We provide end-to-end biobanking consulting for organizations navigating regulatory, ethical, informatics, and operational complexity.
Our work spans academic research, integrated clinical programs, startups, non-profit research foundations, commercial entities, and large, federally funded initiatives operating under high levels of oversight and scrutiny.
We are engaged when programs need clarity, defensibility, and long-term flexibility — not templates or generic advice.
Call Us When…
Your consent language no longer reflects how samples or data are actually being used
An IRB, compliance office, or funder raises questions late in the process
Your biobank expands in scope, collaborators, or geography
Clinical care and research activities begin to blur
Informatics systems move faster than governance frameworks
A new director or leadership team inherits an existing biobank
Accreditation, audit, or external review is approaching
Early design decisions may limit future research or commercial use
You want an independent senior review before issues escalate
Engagements are discreet, tailored, and led directly by senior consultants.
Contact
➤ LOCATION
Durham, NC
☎ CONTACT
(508) 308-3532
helena.ellis@biobankingwithoutborders.com
Areas of Excellence and Experience
Biobanking Informatics and LIMS
Providing expert guidance on biobank informatics strategy, data stewardship, system selection, implementation, and migration — with a focus on regulatory.
Regulatory, Ethical, and Operational Compliance
We provide senior-level guidance across regulatory compliance, ethical governance, and quality systems essential to sustainable biobanking programs.
Our work includes human subjects protections, governance, GxP-informed practices, quality management systems, and preparation for audits and external review. We focus on translating regulatory expectations into operationally realistic practices that remain defensible as programs evolve.
Informed Consent and eConsent
Designing or optimizing human-subjects consent and assent documents that are clear, defensible, and suited for current and future uses — including multi-site and digital environments.
Biobank Build, Expansion, and Relocation
Senior guidance for planning, building, upgrading, or relocating biobanking operations — with attention to regulatory commitments, quality systems, infrastructure, and long-term program continuity.
Governance and Policy Frameworks
Clarifying mission, access policies, data sharing, legacy planning, and oversight structures so biobanking decisions are aligned, transparent, and sustainable.
Financial Stability and Cost Recovery
Advising on budget models, cost recovery strategies, and value propositions that support long-term operations without compromising compliance or mission
Accrediation and External Review Readiness
Preparing programs for successful accreditation, audits, and external evaluations with strategic assessments, quality management alignment, and readiness reviews informed by lived experience.
Click Here for more details on the following services
Governance and Policy Frameworks
Financial Stability and Cost Recovery
Biobanking informatics, LIMS, Data Migration
Informed Consent, Assent and eConsent
Biobank Build and Relocation
Regulatory, Ethical, and Operational Compliance
Accreditation & External Review Readiness