From CRO to Pharma to TechBio

Inferential Data LLC was founded on a simple belief: the best outcomes happen when deep clinical domain expertise meets modern data and AI capabilities—and when strategy doesn't stop at the whiteboard.

Our founder brings a career path that spans Contract Research Organizations, global pharmaceutical companies, and technology-enabled biotech—giving us a perspective that is both broad and deeply specialized.

We understand the pressures facing drug developers, the realities of regulatory expectations, and the promise—and limits—of emerging technology. That combination is rare, and it is the foundation of every engagement we take on.

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CRO Experience

Deep operational knowledge of CRO deliverables, oversight structures, and quality frameworks from the inside out.

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Pharma & Biotech

Sponsor-side strategy and execution across clinical data, regulatory submissions, and compliance programs.

TechBio & Innovation

Product strategy, AI workflow design, and go-to-market support for clinical technology companies.

Core Competencies

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CDISC Standards

SDTM, ADaM, CDASH—from design through submission-ready datasets and reviewer's guides.

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OMOP CDM

Source-to-OMOP ETL, vocabulary mapping, and federated analysis-ready data packages.

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AI & Automation

Practical AI adoption: roadmaps, prototypes, and prompt engineering for clinical teams.

GxP Compliance

CSA, 21 CFR Part 11, eTMF, risk-based monitoring, and audit-readiness across systems and processes.

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Strategic Leadership

Fractional CxO support, M&A data evaluation, and cross-functional alignment for data-driven organizations.

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Real World Evidence

RWD strategy, protocol intelligence, safety insights, and standards harmonization for evidence generation.

Why We Do This

Clinical data is the foundation of every drug approval, every safety decision, and every patient outcome that depends on evidence. We believe that foundation should be strong, intelligent, and ready for the future.

Our mission is to help organizations build that foundation—with expertise, integrity, and an unwavering focus on what matters most: making data work for patients.

Let's Work Together

Whether you need strategic leadership, hands-on execution, or something in between—we'd love to learn about your goals.

Get in Touch