Led by Mike Hittle, PhD in epidemiology and clinical research (Stanford, 2026). Mike is a postdoc in the Ramayya Lab at Stanford Neurosurgery, building a wearable neurological exam for the ICU. He created the PHENOMS platform, co-founded and co-directs Stanford's CS342, co-instructs EPI 270, and co-architected the mHealth Platform 2.0. His published work has 1,636 citations (Google Scholar h-index 10). About Mike.
Who is a fractional CSO for?
- Startups whose product makes, or will make, a clinical or health claim but who have no scientist on the leadership team
- Health-AI teams that need to show their model works on the right population, against the right reference standard
- Founders getting ready for investor or partner diligence on their evidence
- Teams planning an FDA submission who need the evidence side organized before they engage regulatory counsel
What does a fractional CSO do?
A Chief Science Officer owns the question "what evidence do we need, and in what order?" A fractional CSO does this part-time. The work covers evidence strategy, study design and analysis, and the scientific story you tell investors, clinicians, payers and regulators. You get senior scientific judgment without a full-time executive hire.
What's included?
- Evidence strategy: a staged roadmap from your current claims to the evidence each audience needs (pilot, validation, outcomes, real-world evidence), with what each study costs in time and sample.
- Study design: protocols, endpoints, sample size, reference standards, statistical analysis plans, and the data infrastructure to capture them.
- Validation: for sensors and digital measures, planning across the V3 framework: verification, analytical validation, and clinical validation. For AI models, test-set design, reference-standard labeling, and subgroup performance.
- Regulatory evidence support: organizing the clinical and performance evidence that goes into a submission, and working alongside your regulatory counsel. PAHL is not regulatory counsel and does not act as a filer of record or submit on your behalf.
- Scientific advisory boards: defining the expertise you need, drafting the charter and questions, and running productive meetings.
- Publications: a publication plan, abstracts, and manuscripts with proper authorship and reporting standards (e.g., CONSORT, STROBE, TRIPOD+AI as applicable).
How does an engagement run?
- Scoping call30 minutes to understand your product, claims and evidence gaps.
- Initial AuditA fixed-scope audit of your claims and evidence, about 2 weeks.
- Retainer or projectA monthly fractional CSO retainer, or a defined project such as a single validation study.
Questions
Is a fractional CSO the same as an advisor?
No. An advisor gives occasional input. A fractional CSO owns deliverables (protocols, analyses, manuscripts) on a set cadence.
Are you our regulatory counsel?
No. PAHL supports the scientific and evidence side and works with your regulatory counsel. PAHL is not a filer of record.
What is the V3 framework?
A widely used framework for evaluating digital measures in three stages: verification of the sensor, analytical validation of the algorithm, and clinical validation of the measure against the clinical concept.
Do you run the studies?
We design and analyze them. Recruitment and site operations stay with you, your clinical partners or your CRO, and we coordinate with them.
Can you join our scientific advisory board instead?
Sometimes. That is a different role with different expectations, and we'll discuss which fits on the scoping call.
Will you be an author on our papers?
Only where authorship criteria (such as ICMJE) are met. Otherwise contributions are acknowledged.
Related services
Scope it in 30 minutes
Book a scoping call and we'll name the smallest engagement that moves you forward. Most teams start with the fixed-scope Initial Audit.
Book a 30-min scoping callPrefer to write? hello@paloaltohealthlabs.com