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…
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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…
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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…
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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…
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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…
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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…
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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.…
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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,…
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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.…
