Boudicca® DX Precision Medicine Consulting Services
Science-first, Patient-centric & Least-Burdensome
Translational Science Consulting
Biomarker Assay Development | Biomarker Clinical Operations | Companion Diagnostics | Complementary Diagnostics | Data Analysis | Drug Development Tools | Grant Support | Technical Writing
- Guide biomarker strategy benchtop-to-bedside and bedside-to-benchtop
- Manage CDx co-development from concept to commercial launch
- Write grants (SBIR, STTR, EIC & private funding)
- Fractional advisor
- Company is registered in the US federal government’s System for Award Management
- Write technical content for patent applications
- Engage KOLs to support feasibility, clinical validity & clinical utility studies
- Analyze biomarker data (GraphPad PRISM expertise)
- Manage collection of biomarker testing data
- Provide biomarker data harmonization forms for BLA, NDA & MAA submissions
- Execute TCGA & GENIE (cBioPortal) biomarker analysis to support indication selection & biomarker approach
- Manage bioinformatics strategic partners for deeper biomarker analytics
- Guide pharmacodynamic biomarker development for dose decision making
- Support Drug Development Tool (DDT) submissions
- Prepare & review biomarker content in non-clinical & clinical study documentation
- Review Informed Consent Forms for biomarker testing & companion diagnostics testing
- Prepare & submit IRB submissions to central IRBs
US Clinical Laboratory Testing Consulting
Laboratory Developed Tests (LDTs)
- US CLIA LDT development & commercialization
- CLIA, CAP & NYS-CLEP LDTs (clinical trials & commercial testing)
- Support taking CLIA LDTs through US FDA as single-site IVDs
- Reimbursement support (MolDX dossiers & Technical Assessments)
- ASCP-certified Molecular Technologist available for Support
- Fractional Laboratory Director Network
Product Development Consulting
Clinical Diagnostics | Companion Diagnostics | Complementary Diagnostics | Diagnostic Imaging | Digital Health Tools | Digital Pathology | Drug Development Tools | In Vitro Diagnostics | Medical Devices | Software as a Medical Device
- Research Use Only (RUO) product promotional labeling reviews
- Investigational Use Only (IUO) assays & Medical Devices
- In Vitro Diagnostics (IVDs) & Medical Devices
- Drug Development Tools (DDTs)
- Medical Device Development Tools (MDDTs)
- Digital health technologies (DHTs)
- Clinical decision support tools (CDSTs)
- Software as a Medical Device (SaMD)
- Guide regulated product development:
- Recommend & manage testing, CROs & IVD partners/providers
- Provide Clinical Operations services through Partner CRO
- Support analytical and clinical validation planning & execution
- Biostatistician to provide study designs & statistical analysis plans (SAPs)
- Manage intended use clinical sample sourcing strategies (biobank network)
- Commercialization & Reimbursement Strategies
- Design Control
- Design and Development Planning
- Quality Compliance
- Risk Management
- Training workshops (virtual/on-site)
- Support ISO 20387 compliance for high-quality biobanking
- Review Informed Consent Forms
- Generate & submit IRB submissions for validation studies (WCG IRB Connexus account)
- Integrated investigational device monitoring in Biopharma clinical trials
Audit Team:
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- Quality Auditors: ISO 13485:2016 (TPECS) certified with Lean Six Sigma Green & Black Belt
- Regulatory Auditors: 25+ years combined team experience
- Technical Auditors: PhD-trained scientists
- Avaliable to Audit:
- CDx manufacturers
- CROs
- IVD manufacturers
- Design History File (DHF)
- Suppliers (GMP for manufacturers, OEM audits)
- Clinical trial testing (GCP)
- GLP non-clinical studies
- Gap analysis (QMSR, ISO 9001, ISO 13485, & ISO 15189)
- Software (ISO 27001, ISO 42001, IEC 62304)
- Instrumentation (IEC 61010, IEC 61010, & IEC 61326)
- Risk Management (ISO 14971)
- FDA pre-approval inspection audits
- FDA Bioresearch Monitoring (BIMO)
US FDA Regulatory Consulting
Operations | Strategy | Submissions
- US FDA Regulatory Agent Service
- 513(g) requests for information
- Study Risk Determinations (SRDs) via Streamlined IND or Q-submission
- Investigational Device Exemptions (IDEs)
- Humanitarian Device Exemptions (HDEs)
- IND amendments for biomarker assay amendments
- IND non-clinical reports (e.g., algorithm development, cut-off determination, validation summaries, assay modifications, etc.)
- Pre-submissions
- Information Meetings
- Breakthrough Device Designation (BDD) Requests
- Safer Technologies Program (SteP) Requests
- Premarket Approval (PMA) applications
- 510(k)s
- De Novo Requests
- Regulatory insights & intelligence
- Regulatory Advisory Boards for mock regulatory authority meetings & to review regulatory submissions to prepare for questions
- Mock Bioresearch Monitoring (BIMO) & Pre-approval Inspection (PAI) audits
Global Regulatory Consulting
Operations | Strategy | Submissions
Rest of World Regulatory
Support clients with:
- Australia TGA
- Brazil ANVISA
- Swissmedic
- China NMPA
- Health Canada
- Japan PMDA
- Korea MFDS
- New Zealand MEDSAFE
- UK MHRA
Competitive Intelligence & Investment Diligence
- Unparalleled competitive intelligence from 20+ years of precision medicine product development experience
- Clinical, commercial, quality, regulatory & technical diligence to de-risk multi-million dollar investments
- Commercial insights from both precision medicine test & therapeutic vantages
- Provide competitive landscape assessments
- Boudicca® DX consultants are placed in companies by investors to support investments
