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Solving the Challenge of Missing Standards for Pre-clinical Data

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Solving the Challenge of Missing Standards for Pre-clinical Data – Strategies and Best Practices

Author: Frederico Braga, Head of Digital and IT at Debiopharm, and Luca Morreale, Chief Customer Success Officer at MIGx AG
Category: Innovation & Technology
Format: Whitepaper
Estimated read time: ~10 min

Basel, Switzerland – January 14, 2026

Pre-clinical research produces large volumes of complex data, but much of it is still handled with local conventions and one-off definitions. Without shared metadata standards, data is harder to interpret and reuse. It also stays stuck within single studies or teams.

Addressing the Pre-clinical Metadata Gap

In this new whitepaper, Frederico Braga and Luca Morreale examine how metadata, and especially metadata repositories, can address the standards gap. Drawing on the collaboration between Debiopharm and MIGx, they show how clearer definitions, governance, and cultural adoption support more reliable, standardised pre-clinical work.

Why Pre-clinical Metadata Standards Are Missing

Pre-clinical studies span animal models, toxicology, omics, and imaging. Yet there is no widely adopted schema for describing the data. Each lab or team often applies its own definitions and practices, leaving data fragmented and difficult to integrate.

The whitepaper explains what a metadata repository is, what it manages, and why it matters for traceability and reuse. It also outlines how repositories can connect with downstream systems such as LIMS, electronic lab notebooks, and bioinformatics pipelines. It describes how a data quality module can check incoming data against the study definition and agreed metadata specifications, and how these approaches align with FAIR data principles.

In this whitepaper you will discover:

  • How missing metadata standards create inefficiency, poor reproducibility, and regulatory friction.
  • What a metadata repository manages, from dataset definitions and controlled terminology to variable attributes, lineage, and governance.
  • How governance, internal standards, and clear ownership ensure consistency across projects and teams.
  • Why cultural adoption, training, and leadership support drive adoption in daily scientific practice.
  • How integration with lab and informatics systems improves workflow integration and keeps metadata connected to the data.

Frederico and Luca also share a case insight focused on ADC pre-clinical workflows, showing how structured terminology, controlled vocabularies, and better-connected systems can improve auditability and readiness for downstream use.

📥 Submit the form below and receive a Whitepaper PDF via email. Discover how metadata repositories and governance practices can make pre-clinical data more consistent, traceable, and reusable, while aligning with FAIR principles.

Ready to Fix Missing Standards in Pre-clinical Data?

Missing Standards for Pre-clinical Data


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