Trialinx Blog

Clinical research, data quality, and AI workflows

Practical articles on clinical research, methodology, compliance, and AI-assisted workflows. Written by an active clinician.

Electronic Signatures in Clinical Trials: 21 CFR Part 11 Explained

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Electronic Signatures in Clinical Trials: 21 CFR Part 11 Explained

A practical guide to electronic signatures in clinical trials and 21 CFR Part 11, covering signer identity, timestamps, signature meaning, record linking, audit trails, SOPs, and Trialinx signature-event evidence.

May 8, 20268 min read

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Clinical Trial Software for Small Research Teams: What Actually Matters

A practical framework for small clinical research teams comparing clinical trial software, with CRFs, subject tracking, roles, audit trails, exports, AI, and pricing.

May 5, 20267 min read

5 Clinical Trial Data Collection Mistakes Small Teams Keep Repeating

A practical guide to five clinical trial data collection mistakes small teams make, and how to prevent bad data, rework, and painful exports.

May 1, 20268 min read

How to Set Up a Clinical Trial Database in 2026

A practical setup guide for small clinical research teams moving from spreadsheets to structured clinical trial databases, with CRFs, validation, roles, audit trails, exports, and AI review.

April 28, 20268 min read

13 Field Types Every Clinical Research Platform Should Have

A practical breakdown of the 13 field types that help clinical research teams build cleaner CRFs, capture fewer errors, and spend less time fixing data later.

April 23, 20267 min read

Compliance

AES-256 encryption in clinical data: what it is and why it matters

Practical explanation of how AES-256 works, why it's the standard for clinical data at rest, and what your EDC must have.

April 23, 20261 min read

AI & tech

AI in clinical research: realistic use cases in 2026

What AI does and doesn't do in a modern EDC. 5 use cases with real value for clinical researchers.

April 20, 20262 min read

Guides

What is a modern EDC and how to choose one in 2026

The 10 criteria that set a 2000s EDC apart from a modern one, and how to evaluate providers without losing weeks.

April 19, 20262 min read

Methodology

Randomization in clinical trials: simple, block, and stratified

Three randomization methods, when to use each, and how to ensure reproducibility with seeds.

April 15, 20262 min read

Compliance

21 CFR Part 11: complete guide for non-US researchers

What 21 CFR Part 11 requires, when it applies to non-US trials, and how to meet it without over-engineering your EDC.

April 8, 20262 min read

Methodology

How to design an effective electronic CRF

Practical guide to designing an electronic Case Report Form that minimizes collection errors, respects the protocol, and eases audits.

April 1, 20261 min read