Molecular Diagnostics Consulting Services
Laboratory Quality Systems & Inspection Readiness
Biotech Insight Solutions helps molecular diagnostic laboratories develop practical documentation, quality processes, and testing workflows for inspection readiness.
Support may include:
- Laboratory documentation gap assessment
- SOP and technical procedure development
- QC and QA planning
- Validation documentation review
- Proficiency-testing and competency planning
- Inspection-readiness checklist and corrective-action roadmap
- Mock inspection and written findings report
Work is tailored to the laboratory’s testing scope and applicable quality requirements, including CAP- and CLIA-related expectations where relevant.
Scope clarification: Biotech Insight Solutions provides advisory, documentation, and inspection-readiness support. It is not an accrediting or regulatory body and does not issue CAP accreditation, CLIA certificates, ISO accreditation, or regulatory approvals.
LDT Validation & Molecular Assay Implementation
Biotech Insight Solutions helps laboratories and biotechnology teams plan, validate, document, and implement molecular assays moving from development into routine testing.
Support may include:
- Validation master plan development
- Assay validation protocol preparation
- Performance characteristics and acceptance-criteria definition
- Analytical study design and data-review strategy
- Assay troubleshooting and optimization support
- Validation report review and implementation roadmap
Support is available for targeted NGS, PCR and qPCR assays, DNA methylation tests, bisulfite sequencing workflows, and biomarker-based assays.
NGS Workflow & Bioinformatics Assessment
Biotech Insight Solutions assesses sequencing workflows, bioinformatics pipelines, quality-control processes, and result-generation logic for molecular diagnostic assays.
Support may include:
- Sample-to-result workflow assessment
- Sequencing QC and coverage review
- Bioinformatics pipeline logic and parameter review
- Read-alignment, marker-level, and genome-browser assessment
- DNA methylation and bisulfite-sequencing workflow review
- Technical assessment and corrective-action roadmap
Broader research support is also available for RNA-seq, methylation-array analysis, gene-expression profiling, variant and CNV review, functional annotation, and GEO or SRA submissions.
Final clinical interpretation and laboratory sign-out remain the responsibility of appropriately authorized laboratory personnel.
Clinical Study Design & Validation Support
Biotech Insight Solutions supports biotechnology companies and molecular diagnostic laboratories in planning, documenting, and evaluating diagnostic and biomarker-focused clinical studies.
Support may include:
- Clinical study concept and protocol review
- Validation and evidence-development strategy
- Study objectives, endpoints, and acceptance-criteria review
- Assay-performance and clinical-data assessment
- Sample workflow and technical-risk evaluation
- Clinical study documentation and registration support
- Written study assessment and prioritized action plan
Relevant experience includes clinical study registration, validation planning, and translational biomarker development, including work associated with a ClinicalTrials.gov-listed study of hepatocellular carcinoma screening using DNA methylation changes in circulating tumor DNA.
Scientific & Technical Documentation Support
Biotech Insight Solutions develops and reviews scientific and technical documentation for molecular diagnostic laboratories, biotechnology companies, and translational research teams.
Support may include:
- Validation summaries and technical reports
- Assay descriptions and workflow documentation
- SOP and technical-procedure development
- Quality-control and quality-assurance documentation
- Clinical study and technical-file review
- Documentation gap assessment and revision roadmap
Deliverables may be prepared for internal laboratory use, collaborators, partners, investors, or regulatory-facing review, depending on the project.
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