Boudicca® DX Precision Medicine Consulting Services
Operations in both Europe & the United States
Translational Science Consulting
Biomarker Assay Development | Biomarker Clinical Operations | Companion Diagnostics | Complementary Diagnostics | Data Analysis | Drug Development Tools | Grant Support | Scientific Publications | 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 advisors
- 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
- ASHI, CLIA, CAP & NYS-CLEP LDTs (clinical trials & commercial testing)
- Support bringing 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
US 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
- Good Clinical Laboratory Practice compliant biomarker assays
- Investigational Use Only (IUO) assays
- 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
- 21 CFR Part 820 (QMSR) compliance
- 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
- IVD and medical device monitoring
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 with assay development experience
- Audit:
- CDx manufacturers & laboratories
- CROs
- IVD manufacturers
- Design History File (DHF)
- Trial Master File (TMF)
- Suppliers (GMP for manufacturers, OEM audits)
- Clinical trial testing (GCP)
- GCLP laboratories
- GLP non-clinical studies
- Gap analysis (21 CFR Part 820 [QMSR], ISO 9001, ISO 13485, & ISO 15189)
- Software (ISO 27001, ISO 42001, IEC 62304)
- Instrumentation (IEC 61010 & IEC 61326)
- Risk Management (ISO 14971)
- Mock FDA pre-approval inspection audits
- Mock FDA Bioresearch Monitoring (BIMO)
US FDA Regulatory Consulting
Strategy | Operations | Submissions
- US FDA Regulatory Agent Services (Located in the United States)
- eStar submission templates always used when available for least burdensome submissions
- Prepare & Submit eCopy & eStar submissions through CDRH Collaboration Portal
- 513(g) requests for information
- Study Risk Determinations (SRDs) via Q-submissions
- Investigational Device Exemptions (IDEs)
- IDE Amendments and Supplements
- IDE Progress Reports and Annual Reports
- Humanitarian Device Exemptions (HDEs)
- Pre-submissions
- Information Meetings
- Breakthrough Device Designation (BDD) Requests
- Safer Technologies Program (SteP) Requests
- Premarket Approval (PMA) applications
- PMA supplements
- 510(k)s
- Abbreviated, Special & Traditional
- De Novo Requests
- Support clients with IND submissions relating to biomarkers, investigational IVDs & CDx
- Streamlined Study Risk Determinations (SRDs)
- Prepare biomarker content in Briefing Books
- Prepare Cut-off Determination rationale in Briefing Books
- Prepare CDx content in Briefing Books
- Prepare amendments for biomarker assays, e.g., cut-off modifications, reagent shifts, platform migrations, etc.
- Prepare nonclinical reports for Algorithms (testing, training, & validation sets)
- Prepare & review biomarker assay analytical validation reports
- Support clients with determining IDE-exempt, Non-significant Risk (NSR) or Significant Risk (SR) status for their investigational IVDs and medical devices
- Support clients with abbreviated IDE and full IDE compliance
- Support clients with compliance for testing ex-US clinical trial specimens in US-based clinical laboratories
- Submit SRDs for Human Subjects being tested in US laboratories (subject to IDE regulations)
- Support Bioresearch Monitoring (BIMO) program Inspections & Pre-Approval Inspections (PAI)
- Perform Mock Bioresearch Monitoring (BIMO) Inspections & Pre-approval Inspection (PAIs)
- Participate in client’s FDA BIMO & PAI inspections
- Provide regulatory insights & intelligence from continuous FDA submissions experience
- Hold Regulatory Advisory Boards for mock regulatory authority meetings
- Review regulatory submissions to prepare clients for FDA questions
- Provide regulatory education workshops for clients
- Support central IRB submissions for medical devices & IVDs
- Review Informed Consent Forms
Global Regulatory Consulting
Operations | Strategy | Submissions
Rest of World Regulatory
Support clients with global submissions & responding to requests for information:
- Australia TGA
- Brazil ANVISA
- Swissmedic
- China NMPA
- Health Canada
- Japan PMDA
- Korea MFDS
- New Zealand MEDSAFE
- UK MHRA
- Tabular Summaries for IVDs used in Clinical Medicines Trials
- Validation Reports for IVDs
- Checklist Completion
- Performance Evaluations
- UKCA-marking
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 & billion dollar investments
- Extensive experience in Medical device & IVD diligence supporting 20+ investors thus far
- Commercial insights from both precision medicine test & therapeutic vantages
- Provide competitive landscape assessments
- Boudicca® DX consultants can be placed in companies by investors to support investments (fractional appointments)
