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Women’s health clinical trials: breaking down barriers through decentralisation
Patient recruitment is one of the most challenging aspects of running clinical trials. Certain socioeconomic factors, such as the disproportionate…
Governments are playing a bigger role in cell and gene therapy manufacturing
Government institutions are becoming increasingly engaged in cell and gene therapy manufacturing across the US and UK industries, according to…
ViiV Healthcare unveils Phase III trial results of monthly shots to combat HIV
UK-based pharmaceutical company ViiV Healthcare published the results from its two pivotal Phase III trials of its monthly HIV injection…
GDPR: The Implications for Clinical Development
For those based in Europe, the General Data Protection Regulation (GDPR) came into force across the European Union on May…
Medical Device Development – Challenges of an SME
The start of any adventure can often come from the most unexpected quarters. A chance meeting at a conference or…
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MDMA Treatments Found to Eliminate PTSD Symptoms in Phase II Trial
According to a study published by clinical neuroscience in 2000, statistically, each person has a 50 percent chance of experiencing…
How Whole Systems Thinking Could Transform the Clinical Supply Chain
In 2006, the United States Government Accountability Office (US GAO) issued a report, GAO-07-49, highlighting historical attrition rates in drug…
Managing Blinding Requirements in IRT: An Overview
Global clinical trends show an increasing level of complexity in trial design, adding critical challenges on randomization and information blinding.…
Integrating New Assets: A Supply Chain Perspective
The competitive landscape for biopharmaceuticals always seems to be heating up. Internally developed assets are rarely enough to sustain growth,…
Observations from GCP Sponsor Inspections
When it comes to GCP sponsor inspections there are numerous agencies throughout the world that may review your organizational practices.…