Regulatory

The question is whether clinical research is approaching its greatest methodological upheaval since the development of the randomised,...

The FDA is monitoring live clinical trial data using AI in a landmark pilot with AstraZeneca and Amgen. What real-time oversight could mean...

ICH E6 R3 has reset expectations for the Investigator's Brochure. What sponsors and medical writers need to know about safety reporting in...

The UK's biggest clinical trials reform in 20 years takes effect April 2026. What the new MHRA regulations mean for sponsors and trial...

How the FDA’s Plausible Mechanism Framework could transform personalised genomic therapies and treatment development for ultra-rare...

When trial findings are not reported the resulting gaps in the scientific record distort evidence synthesis, misdirect clinical...

When trial findings are not reported the resulting gaps in the scientific record distort evidence synthesis, misdirect clinical...

The world's first human COVID challenge trial has been given the green light

The world's first human COVID challenge trial has been given the green light

Discover how artificial intelligence is affecting medical writing, where its limits lie, and why human judgement remains critical for...

How Paracelsus helped shape modern scientific thinking through observation, toxicology, and early chemical medicine.

The EMA has approved Waskyra for Wiskott Aldrich Syndrome. A personal reflection on Niche's decade long role in this gene therapy's...

Struggling with scientific writing? Discover evidence-based strategies to beat procrastination, structure your work and write with more...

Stability data is a common source of regulatory deficiencies in clinical trial applications. A practical guide to ICH requirements and shelf...

Phase I is the lifeblood or new medicines. The UK’s Phase I representative body,

Having worked in early-stage clinical pharmacology for over 30 years

Concerns about readiness of the European Medicines Agency’s (EMA) Clinical Trials Information System persist as the deadline for...

The clinical stage biotechnology company developing breakthrough therapies for patients suffering with cancer,

Early in 2020, COVID-19 was spreading rapidly across the globe.

Rational Vaccines (RVx) announces MHRA Innovation Licensing and Access Pathway (ILAP) approval for their live attenuated vaccine candidate...

The world's first human COVID challenge trial has been given the green light

There are many regulatory documents but perhaps none are more critical

The latest issue of Journal Frontiers in Pharmacology has just published

Are you a werewolf, ghost, vampire or zombie at conferences? Explore the psychology of conference behaviour — and how to avoid becoming a...

From Tuskegee to the Belmont Report, how did modern research ethics come to be? A reflection on 40 years of principles that still govern...

I'm sure that everyone works hard and tries to do their best.

The EUropean Federation for Exploratory MEdicines Development (EUFEMED

One notable characteristic of Brexit has been a race for the bottom by journalists

Metathesiophobia: from Preclinical to Clinical Development

Metathesiophobia: from Preclinical to Clinical Development

However you may feel about the way political leaders have turned Brexit

The proceedings of the Association for Human Pharmacology in the Pharmaceutical Industry (AHPPI)

Most businesses have standard operating procedures, but does your SOP system include a disaster recovery plan? It should.

Explore how women’s exclusion from clinical trials shaped medicine and why sex-specific data is essential for precision healthcare today.