Whitepapers and Publications

We invite you to gain a first-hand insight into the work and knowledge of our Data Science Specialists:

Below you will find our whitepapers on specific topics from the world of biostatistics and data management, just as a list of publications to which the METRONOMIA team has contributed.

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Contact us for references!

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whitepaper

The Ethics of AI in Medical Writing

This white paper explores how AI is reshaping medical writing, addressing ethical risks and the need to balance speed with accuracy through expert human oversight in scientific documentation.
whitepaper

Volume I – Sustainable Scale: Designing People-Centric Operating Models for Complex Trials

This white paper introduces the structural challenges behind scaling CDM organisations and the design principles needed to support long-term, sustainable growth.
whitepaper

Sample Size Calculations – Practical Guidance Beyond the Formulae

This white paper goes beyond the formulas to explore the real-world trade-offs that shape sample size determination. Designed for clinicians and non-statistical stakeholders, it highlights the practical questions that can determine whether a trial is feasible, credible, and truly informative.
whitepaper

A Biotech Leader's Guide to Success

3 chess pieces

In early clinical development, data is the product and success depends on how fast and credibly it’s generated. A sponsor-owned data strategy, led by Clinical Operations and Biometrics, aligns collection with analysis, enforces standards early, and keeps quality continuous.
whitepaper

Clinical Data Management and Statistical Rescue Services in Clinical Trials

Clinical Data Management and Statistical Rescue Services in Clinical Trials

In the fast-paced world of clinical trials, efficiency, accuracy, and adherence to timelines are essential. However, not all CROs meet the high expectations of trial sponsors. When such deficiencies arise, sponsors are often faced with delays, increased costs, and potential regulatory risks. This white paper discusses the critical role of rescue services in clinical trials, focusing on how they can salvage underperforming studies, restore sponsor confidence, and ensure the successful completion of trials.
whitepaper

An Introduction to Clinical Data Warehousing

Metronomia Whitepaper - Clinical Data Warehouse

The amount of data produced in clinical trials has grown significantly over the past few years. At the same time, reporting and monitoring requirements have become more elaborate. It is not surprising, therefore, that sponsors of clinical trials, biotech and pharmaceutical companies alike, are showing greater interest in the concept of a clinical data warehouse (CDW). In this whitepaper we present the core design principles and use cases of CDWs.
whitepaper

Beyond Traditional Outsourcing: The Data Science CRO Advantage

In today’s rapidly evolving pharmaceutical and biotechnology sectors, the complexities of clinical trials have grown exponentially. Companies are constantly seeking ways to optimize their operations, reduce costs, and ensure the highest quality standards in their studies. Amid these challenges, a specialized approach to outsourcing has gained significant traction: the partnership with a Data Science Contract Research Organization (CRO). This paper explores the benefits of engaging a Data Science CRO and how it can enhance clinical development, particularly for biotech companies.
whitepaper

Benefits of Bayesian Optimal Interval (BOIN) Design for Early-phase Oncology Trials 

Metronomia Whitepaper: Benefits of Bayesian Optimal Interval (BOIN) Design for Early-phase Oncology Trials | Page 1 Benefits of Bayesian Optimal Interval (BOIN) Design for Early-phase Oncology Trials

Early-phase oncology trials, particularly Phase I trials, typically determine the maximum tolerated dose (MTD) to ensure patient safety. While the traditional 3+3 design is common for its simplicity, the Bayesian Optimal Interval (BOIN) design offers greater flexibility and efficiency. This white paper explores the advantages of the BOIN design and compares it to the 3+3 approach using practical examples.
Case study

Driving Innovation: The Metronomia-Medidata Partnership

Medidata Provides Metronomia with The Tools and Expertise to Deliver Excellence for Customers
Case study

Rescue Services: A Global Phase II Study in Dermatology

Metronomia successfully took over Clinical Data Management and Biostatistics for a global Phase II
study in dermatology because of deficiencies in the performance of the previous CRO.
Case study

ISS/ISE Package in Immunology

Metronomia successfully assisted a biopharmaceutical company in preparing an Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) by integrating data from 11 heterogeneous clinical trials, of which five studies had legacy data formats. By standardizing data formats, harmonizing endpoints, recoding medical terminology, and applying advanced statistical methodologies, we delivered a comprehensive ISS/ISE package on schedule, ensuring a smooth regulatory submission and strengthening our partnership with the sponsor.
Case study

Rescue Services: A Pivotal Phase III Study in Oncology

Metronomia successfully rescued a delayed Phase III oncology study by automating data transfers,
enhancing data cleaning and reconciliation, and streamlining the data pipeline. This turnaround
restored confidence in the outcome of the study and led to further collaboration with the sponsor.