Trusted Data Lineage. Actionable Insights.
At TraceLine Solutions, we help biotech and life sciences organizations fix the data layer behind their research. We turn fragmented, inconsistent data into structured, machine-readable assets that can actually be trusted and used for analytics, automation, and AI.
Our practice combines semantic data architecture, end-to-end lineage, and standards-driven automation to make data (re)usable at scale.
Our Services
For Pharma and Biotechs
Clinical
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Establishing your clinical metadata strategy and governance
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Architecting your Metadata and USDM-based Study Definition Repositories
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Harmonizing your standards through semantic modeling: Biomedical Concepts, controlled terminologies, ontologies, CDISC-aligned sponsor libraries
Beyond clinical
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Implementing ontologies, provenance and FAIR principles across research and enterprise data
For CROs
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Building your multi-sponsor standard libraries
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Maintaining sponsor-to-internal mappings as metadata
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Tracing specification changes to code, datasets and outputs
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Preparing your platform for USDM and Biomedical Concepts
For FSPs
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Adding specialist clinical data standards and semantics expertise to your service offering
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Supporting your teams on standards-intensive sponsor programs
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Upskilling your teams on new standards
Our Expertise
Biotech and life sciences organizations generate vast amounts of research data but it often remains fragmented, siloed, and hard to reuse.
Through our consultancy, we help organizations reuse data with confidence, structuring and harmonizing datasets with semantic modeling, provenance lineage, and standards-driven automation.
We apply the same first principles to our data platform, Genome2Protocol, leveraging semantic provenance to harvest insights from federated genomic datasets.
We deliver value through:
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Applying semantic data architecture and FAIR principles to ensure datasets are interoperable and trustworthy
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Integrating distributed datasets to provide a unified, actionable view of complex research data
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Designing practical, workflow-ready solutions that fit seamlessly into existing enterprise operations
Built on TraceLine Solutions' semantic data and provenance expertise, Genome2Protocol is an early-stage research platform that connects fragmented genomic datasets to support decisions across the full drug development pipeline, from target validation and asset prioritisation to protocol design and site feasibility.
By harmonizing federated data and applying ontology-driven mapping, it helps life sciences organisations reduce wasted effort, accelerate trial planning, and ensure underrepresented populations are visible to precision medicine programs.
Meet the team
The team brings decades of clinical data and semantic architecture practice:
Selena, PhD in semantic technologies, combines deep semantic expertise with the strategic and business leadership to turn that vision into practice.
Didier, former Principal Data Scientist at Roche, brings two decades building the standards repositories and CDISC-compliant systems that pharma and biotech depend on, and knows exactly where they break.
Anita, PhD in life sciences, pairs SDTM and CDISC depth with genomics and molecular biology. She speaks both regulatory submission and molecular science fluently.
Dr. Selena Baset
Founder & CEO
Didier Clement
Lead Consultant
Dr. Anita Umesh
Lead Consultant
Dr. Charles Malek
Biopreneur | Strategy consultant Biotech & Pharma
Prof. Dr. Kilian Stoffel
Information Management Institute
University of Neuchatel
Philipp Thomas Ernst
Biomarkers | biomedical data standards expert
Our Advisory Board
The board combines oncology and precision medicine strategy, ontology and knowledge representation, and biomedical data standards expertise from within large pharma. Collectively, they provide the scientific and industry depth to guide both TraceLine's consultancy practice and Genome2Protocol's development.
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Restelbergstrasse 81
8044 Zürich
Get in Touch
Have a question or need assistance? Feel free to reach out to us. We are here to help you with any inquiries regarding our services or solutions.