Best-In-Class Precision Medicine Consulting Services
Clinical Biomarkers & Companion Diagnostics
- Boudicca Dx. best-in-class team of PhD-trained scientists has 50+ years of combined clinical biomarker development experience & 15+ years of combined CDx experience to:
- Support Biopharma with clinical biomarker development for biomarker-defined diseases (non-oncology & oncology)
- Support co-development of FDA-authorized CDx products
- Prepare/review clinical study protocols & reports, non-clinical study reports & all relevant biomarker testing content in Laboratory Manuals, Investigator’s Brochure, etc.
Laboratory Developed Tests
- Support CLIA LDT and EU in-house testing audits for clinical trials (investigational assays)
- Support compliance with EU IVDR General Safety & Performance Requirements (GSPR)
- Support CLIA LDT and EU in-house validation planning & execution
- Boudicca Dx. best-in-class team has 20+ combined years of IVD & LDT development experience to support US FDA Final LDT rule compliance:
- Technical, quality, & regulatory gap analysis, test menu prioritization, & FDA reagent & instrument pivots
- Identify ways to leverage existing CLIA Quality System to reduce burden
- Intended use classification support (Class I, II, or III IVD)
- Immediate templates for Quality Systems requirements (Design Control, Purchasing Controls, etc.)
- Medical Device Reporting (MDR)
- Sample sourcing support for supplemental validation
- Small Business Designation Certification support if appropriate
- FURLS Registration & Listing
- LDT labeling review & support
- Investigational Device Exemption (IDE) requirements for investigational use (pre-FDA authorization phase)
- Pre-submissions to align on validation requirements
- Breakthrough Device Designations submissions for LDTs
- Marketing submissions for commercial use (HDE, 510k, De Novo, & PMA)
Global In Vitro Diagnostics
- Research Use Only (RUO) promotional labeling review
- US & EU Clinical Trial Assays (CTAs)
- US FDA Investigational Use Only (IUO) assays
- EU IVDR Performance Evaluation Only (PEO) Studies
- In Vitro Diagnostic (IVD) product development
- Recommend & manage IVD & biomarker testing providers
- Analytical and clinical validation study plans
- Design Control
- Quality Management System (ISO13485 expertise)
- Risk Management
- Host IVD training workshops
- Manage sample sourcing strategies (relationships with commercial biobanks)
- Support ISO 20387:2018 compliance for high-quality biobanking
- Support A2LA Accreditation for biobanking
- Best-In-Class IVD-trained Audit team in Quality (ISO 13485:2016 (TPECS) certified with Lean Six Sigma Green and Black Belt), Regulatory (25+ years of combined team experience) & Technical (PhD-trained auditors & ASCP-certified Clinical Molecular Technologist)
- Audit:
- IVD developers, including companion diagnostic vendors
- CLIA laboratories testing Biopharma clinical trial specimens
- EU In-house laboratories testing Biopharma clinical trial specimens
Global Regulatory Support
Clinical Trial Assay & IVD submissions
- Study Risk Determinations (SRDs)
- Investigational Device Exemptions (IDEs)
- Humanitarian Device Exemptions (HDEs)
- IND amendments for biomarker testing & assay validation data
- Non-clinical IVD reports for regulatory submissions (e.g., algorithm development, cut-off determination, validation summaries, etc.)
- Pre-submissions
- Breakthrough Device Designation (BDD) Requests
- Safer Technologies Program (SteP) Requests
- Pre-market Approval (PMA) applications
- 510(k)s
- De novo requests
- EU IVDR Performance Evaluation Documentation & Technical Documentation for CE-marking
- Support expert regional consultants (Australia, Canada, China, EU, Japan, China, New Zealand) with global regulatory documentation for IVDs & CDx
- US IRB/ Global EC submissions
Regulatory Advisory Panel
- Provide a panel of regulatory experts for mock regulatory authority meetings (combined 50+ years of regulatory co-development experience) & to review draft regulatory submissions to prepare for regulatory questions
- Evaluate precision medicine co-development (clinical biomarker & companion diagnostic) strategies
- Participate in deep diligence to identify product development risks, i.e., technical, quality & regulatory risks
- Deliver a detailed Diligence Risk Report
- Provide competitive landscape assessments
