Areas of Expertise
Biobanking LIMS and Informatics
Our work includes:
LIMS and biobank informatics strategy and selection
System implementation, migration, and remediation
Alignment of informatics workflows with biospecimen processing
Data stewardship, access controls, and audit readiness
Evaluation of informatics decisions in multi-site or federated environments
We frequently work with programs where technical systems are functioning, but governance and regulatory alignment are unclear or incomplete.
Governance Frameworks and Policy Development
We help organizations establish or refine governance structures that support sustainable and defensible biobanking operations.
Our work includes:
Governance charters and oversight structures
Access and use policies
Data and sample sharing frameworks
Legacy planning and scope evolution
Alignment of governance with institutional priorities and risk tolerance
We are often engaged when governance decisions must support growth, collaboration, or external review.
Regulatory, Ethical, and Operational Compliance
We help programs address ethical and policy questions that arise as biobanks grow, collaborate, or change scope.
Our work includes:
Analysis of ethical and legal considerations in biospecimen and data use
Governance models that respect participant expectations and institutional responsibilities
Support for community trust, transparency, and stewardship
Advisory support for programs operating across jurisdictions or sectors
This work is often undertaken in parallel with regulatory or operational reviews.
Financial Sustainability and Cost Recovery
We advise programs on financial models that support long-term operations while remaining consistent with mission, ethics, and regulatory requirements.
Our work includes:
Cost recovery models
Budget and sustainability planning
Fee structures for internal and external users
Alignment of financial practices with governance and compliance expectations
This work is typically integrated with broader program strategy and operational planning.
Informed Consent and Electronic Consent
We design, review, and revise informed consent and assent materials to ensure they are clear, accurate, and appropriate for current and future use.
Our work includes:
Drafting and revising consent and assent documents
Evaluating consent adequacy for secondary use and data sharing
Supporting transitions to electronic consent platforms
Aligning consent language with governance frameworks and informatics systems
Preparing materials for IRB review and approval
We focus on consent as a living foundation for long-term program flexibility, not a one-time requirement.
Accreditation, Audit, and External Review Readiness
Is your biobank working striving for accreditation by the College of American Pathologists? Let me serve as an external auditor to help you develop strategies in preparation for your inspection, review your Quality Management plan, SOPs, and identify areas for improvement.
Biobank Build, Expansion, and Relocation
We provide senior-level guidance for the design, build-out, expansion, and relocation of biobanking operations, with a focus on maintaining regulatory compliance, quality standards, and program continuity throughout periods of change.
Our work bridges governance and regulatory commitments with practical infrastructure decisions, ensuring that physical spaces, workflows, and systems align with approved protocols, consent frameworks, and quality management requirements.
Our experience includes:
Planning and design of new biobanking facilities
Expansion or modernization of existing biobanks
Relocation of active biobank operations
Equipment selection, qualification, and validation
Alignment of laboratory infrastructure with GxP-informed practices
Integration of quality management systems into new or changed environments
Risk assessment and mitigation during transitions
Biobank build and relocation projects are typically integrated with regulatory review, governance alignment, and quality system assessment.