Practical tissue and biospecimen management consulting for biotech, pharma, and translational research teams focused on reproducibility, assay integrity, and risk reduction.
Tissue handling failures create variability that invalidates cohorts, require expensive rework, and derail study timelines. Pre-analytical errors—from inconsistent fixation to sample misidentification—compromise data quality before assays even begin, wasting months of work and thousands in costs.
Tissue handling failures are a leading hidden cause of assay variability and failed studies. Problems like fixation inconsistency, labeling errors, storage degradation, and chain-of-custody gaps create downstream impact that invalidates cohorts, produces irreproducible results, and forces expensive rework.
These pre-analytical failures often go undetected until late-stage analysis, when sample collection is no longer possible and entire study cohorts must be excluded. The result: delayed timelines, lost investment, and compromised regulatory submissions.
This service is not intended for academic training or routine diagnostic testing.
Identifies failure points in your tissue lifecycle before they compromise assay results
Reduces pre-analytic variability and improves reproducibility across teams and sites
Accessioning, tracking, chain-of-custody, and storage procedures that prevent misidentification and degradation
Pre-analytical variables that compromise downstream assays, with prioritized mitigation steps
Visual documentation of sample lifecycle from collection through analysis, highlighting decision points
Prioritized execution plan with decision points and resource guidance
Risk mitigation through systematic identification and prevention of pre-analytical failures that compromise data integrity and regulatory readiness.
Variable fixation timing or methods create systematic differences that render group comparisons meaningless
Labeling errors or tracking failures invalidate patient samples, requiring complete cohort exclusion and re-collection
Temperature excursions or improper storage conditions degrade samples, producing false negatives or unreliable results
Missing documentation or tracking failures create regulatory risk and potential data integrity challenges during inspections
Inefficient processes create processing delays that cascade into missed deadlines and delayed submissions
Total engagement typically 4–7 weeks depending on scope and complexity. Rush delivery available for urgent needs.
Discuss a Tissue Workflow Review or Request a Project Estimate
Request a Tissue Workflow ReviewWe review your study goals, available tissues, existing protocols, and constraints. This initial assessment identifies gaps, risks, and optimization opportunities.
We evaluate your current workflows, sample handling, assay performance, or pathology data quality. This identifies failure modes and decision points.
We deliver concrete outputs—protocols, SOPs, review reports, or workflow frameworks—with implementation guidance and follow-up support as needed.
Standardized tissue-handling SOPs for a multi-site US clinical trial to eliminate pre-analytical batch effects.
Optimized fixation and cold-ischemia protocols for a Boston-based startup to protect rare tumor samples.
Conducted a biorepository audit for a mid-sized biotech, identifying and mitigating 15% loss-risk in archived cohorts.