Consulting & CRO
Expert consultants all with 10+ years of professional experience and customized CRO services
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01
Translational Science
End-to-end biomarker strategy from bench to bedside — CDx co-development, pharmacodynamic biomarkers, DDTs, and grant writing.
02
Clinical Laboratory Testing
Full-cycle CLIA LDT development and commercialization — CAP, ASHI, NYS-CLEP accreditation, FDA single-site IVD pathways, and reimbursement.
03
Product Development & Quality
Full-cycle IVD, medical device, SaMD, and CDx development — analytical and clinical validation, 21 CFR Part 820 compliance, and ISO-certified quality auditing.
04
US FDA Regulatory
Full submission spectrum — 510(k), PMA, De Novo, BDD, IDE, SteP, Q-Sub, HDE — plus IND biomarker content, BIMO participation, and ex-US specimen compliance.
05
EU IVDR & MDR
Ireland-based EU legal and authorized representative services — CE-marking, performance studies, Article 5(5) compliance, Notified Body submissions, and EMA CDx alignment.
06
Global Regulatory
Submissions and RFI management across nine global markets — TGA, ANVISA, Health Canada, NMPA, PMDA, MFDS, MEDSAFE, Swissmedic, and MHRA.
07
AI-Assisted Regulatory Intelligence
Claude-powered regulatory research — rapid synthesis of FDA, EMA, and MDCG guidance; EU/US requirement comparisons; SOTA literature searches. Public data only. Expert review at every step.
08
Competitive Intelligence & Investment Diligence
Actionable diligence for investors and biopharma — clinical, commercial, quality, regulatory, and technical dimensions across IVD and medical device portfolios.
Managed CRO partner
09
Clinical Trial Execution (CRO)
Full-service CRO via our managed partner — trial design, site qualification, monitoring, data management, and biospecimen logistics. Fully managed by Boudicca® DX.
All services available on-demand — ad hoc, project-based, or retained fractional. Questions about scope or fit? Talk to an expert →
Translational Science
Support clients developing biomarker strategies, clinical trial biomarker assays, and companion diagnostics from preclinical through regulatory submissions.
End-to-end biomarker strategy from bench to bedside executed by PhD scientists with Biopharma experience.
Clinical Laboratories
Support CLIA laboratories, clinical labs seeking FDA authorizations, and biopharma sponsors managing clinical trial testing.
Bench and documentation level diligence by certified laboratory professionals.
Analytical Validation Training
Product Development
Support IVD manufacturers, medical device developers, and digital health companies moving from concept through commercial launch.
Full-cycle support across IVDs, LDTs, medical devices, SaMD, DHTs, CDSTs, DDTs, and MDDTs from credentialed experts.
- Analytical & clinical validation — study design and execution; decades of hands-on experience
- Regulatory labeling reviews
- QMSR / 21 CFR Part 820 compliance — design control, process validation, risk management, V&V
- Biostatistics support — GLP and GCP-compliant study designs and statistical analysis plans (SAPs)
- Clinical sample sourcing — via ISO 20387-accredited biobanking network; ICF reviews and IRB submissions
- IVD and medical device clinical trial monitoring
- Reimbursement strategy — clinical utility studies, payer strategy, commercialization planning
- Usability engineering — human factors study design and documentation per IEC 62366
US FDA Regulatory
Support IVD developers, CDx sponsors, biopharma regulatory teams, and clinical laboratories navigating FDA submissions, IDE compliance, and inspection readiness.
US-based regulatory agent services from FDA experts covering IVD and medical device submissions prepared in the least-burdensome manner using eStar templates via the CDRH Collaboration Portal.
IVD and Medical Device Submissions
- 513(g) requests for information
- Q-submissions — Breakthrough Device Designations (BDD), Pre-submissions, Information Meetings, STeP requests, Study Risk Determinations (SRDs)
- IDEs — applications, amendments, supplements, and annual reports
- HDEs — Humanitarian Device Exemptions
- 510(k)s — abbreviated, special, and traditional
- PMAs and sPMAs — Premarket Approvals and supplemental PMAs
- De Novo requests
- Predetermined Change Control Plans (PCCPs)
IND Biomarker Support
- Interact, Pre-IND, and IND content — investigational IVDs, CDx assay amendments, cut-off determination rationale, algorithm validation reports
- Streamlined IND Study Risk Determinations (SRDs)
- Ex-US specimen testing compliance
- EOP briefing book content — biomarker & CDx content
BLA and NDA Biomarker Support
- Briefing book content — biomarker & CDx content
- CDx Postmarketing commitment (PMC) — support alignments
Inspection & Advisory
- PAI and BIMO inspection support
- Mock regulatory advisory boards
- Regulatory education workshops
- IRB submissions and ICF reviews
- FOIA requests — to reconstruct regulatory history
Quality Compliance
For CDx and IVD manufacturers, medical device companies, CROs, and clinical laboratories preparing for FDA inspections, Notified Body audits, or internal quality system improvements.
Expert quality auditors and regulatory compliance specialists including ISO 13485:2016-certified quality auditors with Lean Six Sigma credentials, PhD-trained technical auditors, and QMSR-fluent compliance experts who audit across the full precision medicine product development ecosystem.
- Audit scope — DHF/TMF reviews · supplier and OEM audits · GCP clinical trial testing · QMS (ISO 9001, ISO 13485, ISO 15189) · 21 CFR Part 820 (QMSR) · software (ISO 27001, ISO 42001, IEC 62304) · instrumentation (IEC 61010/61326) · IQ/OQ/PQ · risk management (ISO 14971)
- Client types audited — CDx manufacturers, IVD manufacturers, medical device manufacturers, CROs, GCLP laboratories, GLP non-clinical study sites
- Mock FDA PAI and BIMO inspections — front room and back room support to identify and remediate findings before agency visits
- QMSR expertise — 21 CFR Part 820 Quality Management System Regulation compliance for US-marketed devices
Global Regulatory
For clients with multi-market submissions and global clinical trials.
Decades of experience handling regulatory submissions and RFIs across nine global markets with extensive experience in global CDx submissions, clinical bridging studies, and multi-jurisdiction approvals.
Markets
- Australia — TGA
- Brazil — ANVISA
- Canada — Health Canada
- China — NMPA
- Japan — PMDA
- Korea — MFDS
- New Zealand — MEDSAFE
- Switzerland — Swissmedic
- United Kingdom — MHRA (including CTA submissions, checklist and tabular summary format)
Global CDx Strategy
- Global CDx regulatory strategy — harmonized multi-jurisdiction approach from a single clinical dataset
- CDx clinical bridging study design and execution — with biopharma and CDx manufacturer partners
- Multi-jurisdiction CDx approvals — US FDA, PMDA, NMPA, EMA; simultaneous or sequential
- EU IVDR performance study applications — per MDCG 2022-19
AI-Assisted Regulatory Intelligence
For regulatory affairs teams, biopharma sponsors, and IVD developers who need faster, more current regulatory intelligence without compromising quality or client confidentiality.
Boudicca® DX uses Claude by Anthropic to synthesize publicly available regulatory information at speed — with mandatory expert consultant review at every step. No client data. No proprietary strategies. Public regulatory information only.
- eStar template compilation and cross-referencing — FDA IDE, 510(k), De Novo, PMA submission requirements & deployable filing systems
- EU/US regulatory comparison — side-by-side analysis of IVDR and FDA analytical validation terminology, performance study expectations, and submission documentation standards
- State-of-the-art (SOTA) literature searches — AI-assisted, executed by PhD-trained scientists for EU IVDR, EU MDR, UK MHRA, US FDA, and ROW submissions
- Continuous regulatory monitoring — FDA, EMA, MDCG, Notified Bodies, UK MHRA, and ROW guidance updates tracked in real time
- Public database synthesis — 510(k) databases, De Novo summaries, PMA records, and regulatory decision summaries to inform study designs
- Expert gap review — all AI-assisted outputs reviewed by expert consultants before delivery
AI synthesizes from current regulatory guidance documents in real time. Unlike static navigators, no software license is required.
Competitive Intelligence & Investment Diligence
For investors, acquirers, and biopharma business development teams evaluating precision medicine assets, diagnostics companies, and IVD programs.
Twenty-plus years of precision medicine product development experience translated into actionable investment diligence — covering clinical, commercial, quality, regulatory, and technical dimensions to de-risk multi-million and billion-dollar decisions.
- Investment diligence — 20+ engagements supporting medical device and IVD diligence across clinical, regulatory, quality, and commercial dimensions
- Competitive landscape assessments — technology, regulatory, and commercial vantages across diagnostic and therapeutic programs
- AI-assisted public database mining — for clinical, technical, regulatory, and commercial intelligence
- FOIA requests — deeper dives into non-public regulatory history for diligence purposes
- Fractional portfolio company placement — BDX consultants available for ongoing post-investment support within portfolio companies
Strategic Partnership
Managed Full CRO Services
Precision medicine clinical trials, fully integrated with BDX regulatory strategy.
Boudicca® DX has partnered with a precision medicine-focused, full-service CRO with 20+ years of experience designing, initiating, and managing complex IVD, companion diagnostic, and medical device clinical trials. The partnership covers the full clinical research lifecycle from feasibility and protocol design through site management, monitoring, data management, biospecimen logistics, and program oversight.
BDX directs the partnership and owns the regulatory strategy in-house. Clients work with one accountable team that builds trial design, IVD submissions, and CDx development together from day one — receiving competitive costing and direct access to BDX regulatory intelligence alongside expert clinical operations execution, without managing two separate vendor relationships.
One relationship. Fully integrated execution.
Most biopharma and IVD companies manage their CRO and regulatory consultant separately, creating gaps between clinical trial design and regulatory strategy that cost time and money. BDX directs the clinical operations partnership and owns the regulatory strategy, so trial design, IVD submissions, and CDx development are built together from day one.
How the Partnership Works
Two teams, one accountable structure. BDX owns the regulatory strategy and directs the partnership. The CRO partner executes clinical operations under BDX direction.
BDX Owns
- Regulatory strategy across EU, US, and ROW
- Protocol design and endpoint alignment with submissions
- Sponsor delegation and oversight
- CDx co-development strategy and bridging
- Direct client communication and program leadership
Partner Executes (Under BDX Direction)
- Site qualification, start-up, and management
- On-site and remote monitoring (risk-based)
- Data management, EDC, and biostatistics
- Biospecimen sourcing, logistics, and biorepository
- Trial Master File and project management
CRO Partner · At a Glance
20+
Years in precision medicine trials
ICH-GCP
GCLP
GCLP
Certified across regulatory frameworks
US · EU
ROW
ROW
Active sites across three regions
IVD · CDx
MedDev
MedDev
Trial expertise across program types
The CRO partnership is exclusive to Boudicca® DX clients and is not separately marketable. Partner identity is disclosed under MSA. This structure protects the partner relationship and ensures BDX clients receive priority access without competing for capacity.
Full-Service Clinical Operations
Four integrated capability pillars covering every operational dimension of an IVD, CDx, or medical device clinical program. Click any sub-service to expand the full scope.
01 / Clinical Operations
Trial Design & Management
Clinical trial strategy and design services compliant with ICH and GCP standards, covering protocol development, site qualification, monitoring, and master file management.
Trial Design & Protocol Development ›
Trial Feasibility Assessment
- Impact of inclusion / exclusion criteria
- Availability of target subject population
- Likelihood of subject participation
- Projected enrollment rates
- Investigator interest assessment
- Compatibility with standard of care
- Site capabilities and infrastructure
- Vendor capabilities
- Study logistics
- Local and central IRB issues
- Financial considerations
- Competing trials
Trial Design (New Studies)
- Study groups and target cohort size
- Biostatistical significance planning
- Inclusion / exclusion criteria
- Logistical design
- ICH-GCP compliant study protocols
- Protocol amendments
- Model Patient Informed Consent Forms
- Case Report Forms and instructions
- Clinical Trial Management Plans
- Site development and management plans
- Data management plans
- Biospecimen management plans
- Monitoring plans
Clinical Site Qualification & Start-Up ›
Site Qualification Visits (SQVs)
- Site Recruitment Questionnaires
- Telephonic site screening interviews
- Protocol reviews with investigators
- Qualification visit travel coordination
- On-site qualification visits and audits
- Site Qualification Report documentation
Clinical Trial Agreement (CTA) Negotiation
- Study site budget development
- Contract key terms and milestones
- Risk sharing models
- Financial negotiation
- Final contract execution
IRB / EC Submissions & Approvals
- Manage protocol submissions and approvals
- Coordinate investigator approvals
- Re-submissions and re-approvals
- Protocol revisions and amendments
Clinical Site Management ›
Management of Clinical Sites
- Site operations oversight
- PI and CRC relationships
- Study-specific question handling
- Site feedback coordination
- Performance metrics reporting
- Milestone tracking (FPI, LPI, LPO)
Specialty (Central) Lab Management
- Instrument install and de-install
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
Third-Party Vendor Management
- Clinical Research Organizations
- Site Management Organizations
- Contract Diagnostics Organizations
- Clinical Data Management providers
- External biorepository facilities
- Production and manufacturing facilities
- Packaging facilities
- Supply and logistics vendors
Clinical Study Financial Management
- Real-time financial oversight
- Invoice review and reconciliation
- Milestone payment tracking
- Bonus and incentive tracking
- Compliance results tracking
On-Site & Remote Monitoring ›
Site Monitoring Services
- Monitoring visit travel coordination
- Enrollment progress review
- Regulatory document review
- Source document review
- Data verification and monitoring
- Investigational product accountability
- Equipment monitoring records
- Site deviation review
- Adverse Event report review
- Data discrepancy resolution
- Site monitoring report delivery
- Regional monitor coordination
Risk-Based Monitoring
- Study and site-specific monitoring plans
- Predicting and preventing critical issues
- Adaptive monitoring type and frequency
- Study deviation tracking and resolution
Trial Master File (TMF) Management ›
- Secure cloud-based TMF setup
- Industry-compliant TMF structure
- Custom or DIA reference model
- Routine filing and maintenance
- Completeness reviews and audits
- Investigator Site Files (ISFs)
- Regulatory binders
- Data binders as needed
Project Management ›
Project Set-Up
- Project feasibility assessments
- Scope of work development
- Critical path planning
- Resources, roles, responsibilities
- Communication plans
- Deliverables and quality standards
- Milestones and budgeting
- Training and project initiation
- Progress metrics development
- Risk Evaluation and Mitigation
Ongoing & Completion Services
- Project leadership
- Timeline management
- Regular reports and metrics
- Progress review meetings
- Problem solving
- Financial reconciliation
- Change order implementation
- Completion audit
- Final report dissemination
02 / Clinical Operations
Data Management
Comprehensive support for quality data collection, curation, and analysis from CRF design through final statistical reporting.
Case Report Forms ›
- Protocol-based data element design
- Hardcopy worksheets
- Electronic CRF development
- Data flow specifications
Cloud EDC Database Configuration ›
- Study database customization
- eCRF creation and form rules
- Consistency, error, edit checks
- User Acceptance Testing (UAT)
- Validation testing
- User training and support
Data Quality Control ›
- Real-time submission and source verification
- Data query and discrepancy resolution
- Summary data and metrics reporting
- Final data unblinding and reporting
Biostatistics ›
- Sample size analysis
- Statistical Analysis Plan (SAP)
- Analytical study design
- Clinical validation study design
- Study interim analysis
- Sample size re-estimation
- Study final data analysis
- GCP-compliant reporting
03 / Clinical Operations
Program Management & Operations
Day-to-day program management, operational efficiency, and business intelligence to align organizational resources with strategic objectives.
Project & Program Management ›
- Project feasibility assessments
- Scope of work and critical path planning
- Resources, roles, responsibilities
- Communication plans and deliverables
- Quality standards and milestones
- Project budgeting
- Training and project initiation
- Risk Evaluation and Mitigation
- Project leadership and team management
- Timeline management
- Financial management and reconciliation
- Change order implementation
Operations & Efficiency Consulting ›
Organizational Consulting
- Strategy consulting
- Organizational structure consulting
- Performance management consulting
- Business process reengineering
- Change management
- Crisis management
- Facilities planning
Technical Process Review
- Operations and efficiency consulting
- Process review and improvement
- Throughput analysis
- Gap analysis
- Performance metrics
- Workflow design
- Lean improvements
- Visual workplace improvements
Auditing Services ›
General Auditing
- Audit plan preparation
- SOP and QMS documentation review
- Staff training review
- Procedure review
- Observation documentation
- Audit report delivery
- Resolution guidance
Internal Auditing
- Trial Master File (TMF) audits
- Data and database integrity audits
- Inventory audits
- Technical process audits
- Certification audit preparedness
Clinical Site Auditing
- Sponsor protocol compliance
- Regulatory file and IRB audits
- Contractual agreement terms
- Internal site SOPs
- Sponsor requirement compliance
- Adverse Event reporting
Lab & Vendor Auditing
- Organizational structure
- Experience and resource verification
- Standard Operating Procedures
- Facilities and equipment
- Equipment monitoring and calibration
- Data collection and handling
Business & Market Intelligence ›
Market Research & Analysis
- General background research
- Market and industry research
- Product and competitor analysis
- Sponsor landscape analysis
Due Diligence Services
- M&A and alliance evaluations
- Pre-investment VC evaluations
- Negotiation support information
- Investor and VC presentations
04 / Clinical Operations
Biospecimens & Logistics
Fit-for-purpose biospecimens and processes, from sourcing through global logistics, central lab management, and full-range biostorage.
Biospecimen Sourcing ›
- Biospecimen requirement summaries
- Custom collection protocols
- Collection and preparation methods
- Stabilization and preservation methods
- Processing methods
- Iatrogenic and pre-analytical variable tracking
- Prospective material sourcing
- Retrospective material identification
- Biospecimen honest broker services
Biospecimen Collection Kit Design ›
- Sample and data labeling schemas
- De-identification schemas
- Barcode design and scan compatibility
- Collection consumable specifications
- Processing consumable specifications
- Storage consumable specifications
- Shipping consumable specifications
- Consumable distribution tracking
- Supply replenishment tracking
Central Laboratory & Biorepository Management ›
Existing Facility Assessment
- Inventory audits
- Operations review and gap analysis
- Biorepository risk analysis
- Material value assessment
- Operating cost analysis
- CAP accreditation guidance
Facility Planning, Design & Operations
- Biorepository facility design
- Good Storage Practices (GSP)
- Operations and management
- Temperature monitoring systems
- Health, safety, security
- Emergency notification systems
- Power and coolant back-up
- Biospecimen handling workflow
Supported Storage Conditions
- Liquid nitrogen (-196°C)
- LN₂ vapor phase (-130°C to -150°C)
- Ultra-low freezers (-70°C to -80°C)
- Standard freezers (-20°C)
- Refrigeration (2°C to 8°C)
- Controlled / ambient (15°C to 27°C)
Biorepository Relocation
- End-to-end planning and coordination of biorepository relocation projects
Import / Export & Shipping Logistics ›
- Express courier coordination
- Ambient and frozen deliveries
- US customs clearance
- EU customs clearance
- Shipment tracking
- Shipment troubleshooting
Biostorage Coordination ›
- Sample management plan coordination
- Biostorage service provider selection
- Inventory data management
- Sample selection workflows
Trial Types Supported
Exploratory
Feasibility, proof of concept, pilot
Pivotal
Performance, safety & efficacy, bridging, label expansion
Post-Marketing
Follow-on, human factors, registries
Non-Clinical & Analytical
Investigational plans, analytical validation
Regulatory Frameworks Covered
ICH-GCP
GCLP
ISO 20916
ISO 14155
US IRB
ROW Ethics Committees
HIPAA Compliance
Adverse Event Reporting
Why This Matters
Clinical trial execution and regulatory strategy are not separable for IVD and CDx programs. Decisions made in trial design, including endpoint selection, sample collection protocols, central lab qualification, and data management plans, directly determine whether a regulatory submission succeeds. By owning the regulatory strategy in-house and directing the clinical operations partnership, BDX ensures every clinical operations decision is made with the regulatory outcome already in view.
Ready to discuss your program?
Integrated clinical and regulatory delivery for IVD, CDx, and medical device programs.
