Clinical software · Genomics software · Bioinformatics
Technical and clinical review of clinical software, genomics software, and bioinformatics platforms.
Pacidi helps health-tech investors and founders evaluate the scientific, technical, and regulatory soundness of clinical software, genomics software, and bioinformatics platforms. Founded by Pieter-Jan van Dam — MD, PhD in bioinformatics and molecular pathology. He serves as reporting Principal Investigator on clinical genomics trials at a global CRO, where he is also Associate Director Data Science, leading software development and bringing new data implementations into production.
Clients
Who Pacidi works with
Health-tech investors
Technical and clinical due diligence for VCs and PE firms evaluating clinical software, genomics software, bioinformatics platforms, and AI/ML tooling companies. Written reports that give your investment committee a clear picture of what they're actually buying.
Founders and operators
IVDR readiness reviews, bioinformatics pipeline audits, and clinical-methodology sanity checks for teams preparing for Notified Body review, a funding round, or a strategic partnership.
Life-science software companies
Independent review of clinical claims, validation methodology, and software quality for companies selling into regulated clinical and research markets.
Offerings
Services
Every engagement is scoped and priced upfront. Deliverables are written. Most engagements complete in one to three weeks. All prices exclude VAT.
- 01
Clinical and scientific validity review
Review of a product's clinical claims against its underlying methodology and validation data. Does the science support what's on the marketing site? Covers the performance evaluation dossier, validation studies, published comparators, and the methods documentation, delivered as a structured written assessment.
- Scope
- 8–15 hours
- Turnaround
- 1 week
- Deliverable
- Written report with findings, severity ratings, and recommendations.
Starting at€3,500 - 02
IVDR regulatory posture review
Gap assessment for clinical software, IVD software, or clinical genomics products preparing for Notified Body review, or under investor scrutiny. Covers classification logic, QMS maturity, technical documentation completeness, performance evaluation, and post-market surveillance planning.
- Scope
- 6–12 hours
- Turnaround
- 1 week
- Deliverable
- Written memo with prioritized findings and a remediation roadmap.
Starting at€3,000 - 03
Bioinformatics pipeline audit
Independent methodology and code review of a bioinformatics pipeline or tool. Appropriate for clinical NGS workflows, variant-calling pipelines, and research-grade tooling being hardened for regulated use. Scoped to specific components, with upfront clarity on what can and cannot be verified in the time available.
- Scope
- 15–30 hours
- Turnaround
- 1–2 weeks
- Deliverable
- Written report covering methodology, reference choices, statistical approach, code quality signals, and scalability assessment.
Starting at€6,000 - 04
AI/ML model audit
Independent review of an AI or machine-learning model used in a clinical or research setting. Covers training data integrity, evaluation methodology, generalizability and bias signals, clinical-claim alignment, and the documentation needed for Notified Body or investor scrutiny. Appropriate for diagnostic models, clinical decision-support tools, and research-grade ML being hardened for regulated use.
- Scope
- 15–30 hours
- Turnaround
- 1–2 weeks
- Deliverable
- Written report covering data, methodology, evaluation, claim alignment, and risk findings.
Starting at€6,000 - 05
Combined technical + clinical + regulatory due diligence
Full pre-investment or pre-acquisition review of a clinical software product. Covers the three dimensions most reviewers cannot cover alone: is the code any good, does the science hold up, and is the regulatory posture real or performative.
- Scope
- 40–80 hours over 3–4 weeks
- Turnaround
- 3–4 weeks from kickoff
- Deliverable
- Comprehensive written report, executive summary with traffic-light risk rating, and follow-up Q&A.
Starting at€12,000 - 06
Written advisory retainer
Monthly async advisory for early-stage founders who need ongoing input on clinical, regulatory, and technical decisions without hiring a full-time advisor.
- Scope
- 4 hours / month minimum
- Turnaround
- Written responses within 2 business days
- Deliverable
- Written responses plus a monthly summary memo.
Starting at€1,800/ month
Method
How engagements work
Deliverables are written. You receive a structured report you can share with your investment committee, your board, or your regulatory team — not a set of meeting notes. Written analysis forces rigor and produces an artifact with a clear audit trail.
Engagements start with a written brief or a kickoff call. You describe what you're evaluating, what you're worried about, and your timeline. Pacidi replies within two business days with a fixed-scope proposal: hours, deliverables, price, and what is explicitly in and out of scope. If you proceed, management Q&A happens via written questions and recorded walkthroughs. A short call at the end is available if your team wants to walk through findings live.
Limitations are stated explicitly. A 20-hour code review is not a 200-hour code review, and is not presented as one. You'll know exactly what was examined, what was inferred from signals, and what remains unverified. That's what separates real technical review from box-ticking.
Confidentiality and conflict clearance are handled upfront. Every engagement begins with a mutual check: I disclose active and recent clients that could constitute a conflict; you describe your product and closest competitors in enough detail for me to assess overlap. If there is a conflict, I decline — or both parties agree in writing on narrowed scope. Inquiries and engagements are covered by mutual confidentiality from first contact, whether or not we proceed.
About
Background
I trained as a medical doctor and completed a PhD in bioinformatics and molecular pathology. I currently serve as reporting Principal Investigator for clinical genomics trials at a global clinical research organization. Within the same organization, I am Associate Director Data Science, leading software development and data implementations across the business. My latest project is the design, development, and implementation of a laboratory execution system (LES) that replaces multiple spreadsheets and reduces manual intervention.
This combination — clinician, scientist, and working engineering leader across software, data, and AI — is uncommon, and it's why my reviews catch things single-discipline reviewers miss. I can read the clinical literature, read the code, and tell you whether the two actually agree.
Contact
Start an engagement
Send a short description of what you're evaluating and your timeline. Replies arrive within two business days. If it's a fit, you'll receive a fixed-scope proposal.
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