The Blog

The Blog

Get the latest updates, insights and best practices on data management and biostatistics in clinical trials.

A Brief Overview of the Quality Checking Process

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Writing a Clinical Study Protocol as a Regulatory Document

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Important Mistakes to Avoid Before Submitting a Molecular Biology Manuscript

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Overcoming the Paradox of Choice: Selecting EDC Capabilities to Fit Your Needs

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Medical Writers – Who We Are and What We Do

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The Cost of Queries, Reduce the Burden, Risk based Data Management, Targeted Data Review

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Risk based Data Management, nay targeted data review

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Biostatistics, Data Management, and Medical Writing: a Multidisciplinary Approach to the Development of the CTD Integrated Summaries

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A “Rescue” Study Doesn’t Have To Be Daunting: Six Best Practices To Factor Into Effective Data Migration Planning

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A Guide to the Multifaceted Role Biostatisticians Play in Clinical Research

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Case Study: Preparing a New Drug Application with a CDISC Conversion

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Benefits of Automating, Accelerating and Unifying the SDTM Conversion Process

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Data managers in a changing technological landscape

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AI in data management

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Getting Closer to Source Data

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Levels of Scientific Evidence

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Managing the Writing of a Multi-Author Paper

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What Is A Data-Focused CRO, And What Are Its Benefits?

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Risk Based Approach in Data Management

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Regulatory Landscape

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At A Glance – What’s New In The FDA Technical Conformance Guide Version 3.3

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Study Data Standardization Plan – Importance And Advantages

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SEND – Overview In Light Of FDA Requirements

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