Whitepapers
In-depth whitepapers exploring the methods, decisions and practical challenges shaping biometrics and clinical development.
Volume II – Process Debt: The Hidden Cost of Scaling Without Process Redesign
As CDM organisations scale, hidden operational pressures accumulate beneath successful delivery — until they affect quality, timelines and workforce sustainability. Volume II reveals the risks of scaling without process redesign.
2026-05-20
Volume I – Sustainable Scale: Designing People-Centric Operating Models for Complex Trials
As Clinical Data Management grows more complex, many organisations are asked to scale faster than their operating models allow. Volume I explores people-centric operating models built for complexity, accountability and resilience.
2026-04-15
The Ethics of AI in Medical Writing
As AI transforms medical writing, teams must adopt new tools without sacrificing scientific accuracy or regulatory compliance. This paper weighs innovation against ethical responsibility and the need for expert human oversight.
2026-03-10
A Biotech Leader's Guide to Success
In early clinical development, data is the product — success depends on how fast and credibly it's generated. How sponsor-owned data strategies align collection with analysis while protecting quality.
2026-02-12
Beyond Traditional Outsourcing: The Data Science CRO Advantage
As clinical trials grow more complex, sponsors are turning to a specialised model of outsourcing — the data science CRO — to optimise operations, control cost and protect quality across their studies.
2025-11-18
Clinical Data Management and Statistical Rescue Services in Clinical Trials
How rescue services turn around underperforming trials: when to engage a data science CRO, best practices for recovery, and the capabilities needed to resolve delays, cost overruns and regulatory risk.
2025-09-24
Benefits of Bayesian Optimal Interval (BOIN) Design for Early-phase Oncology Trials
Early-phase oncology trials must find the maximum tolerated dose safely. This paper compares the traditional 3+3 with the Bayesian Optimal Interval (BOIN) design and its advantages in flexibility and efficiency.
2025-06-30
Sample Size Calculations – Practical Guidance Beyond the Formulae
How many patients are enough? Behind every sample size lies a set of assumptions about treatment effect, variability, risk and feasibility — a practitioner's guide to the real-world trade-offs beyond the formulae.
2025-04-08
An Introduction to Clinical Data Warehousing
With clinical trial data volumes growing and reporting demands rising, this paper sets out the core design principles and use cases for clinical data warehouses — architecture, integration, bi-directional data flow and vendor considerations.
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