Current Edition

US FDA Publishes Draft Guidance
Volume 12 Issue 5

US FDA Publishes Draft Guidance for Industry Regarding Cannabis and Cannabis-derived Compounds

In July 2020, the US Food and Drug Administration (FDA) published the draft guidance entitled Cannabis and Cannabis Derived Compounds: Quality Considerations for Clinical Research …

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Cerebral Palsy Rescue Study
Volume 12 Issue 5

Cerebral Palsy Rescue Study

Patient enrolment is a pivotal aspect of any clinical trial. Without a large enough subject group, trial results may lack statistical significance as not enough …

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Changing Rules on Data Transfer from the EU
Volume 12 Issue 5

Changing Rules on Data Transfer from the EU

The introduction of the General Data Protection Regulation (Regulation (EU) 2016/679) (“GDPR”) was a painful process for many companies as databases were stripped, new practices …

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Ensuring Diversity in COVID-19 Vaccine
Volume 12 Issue 5

Ensuring Diversity in COVID-19 Vaccine Registration Trials

While more information needs to be learned about COVID-19, it has become clear that poorer outcomes and the risk of mortality in the US population …

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Risk-based Monitoring
Volume 12 Issue 5

Risk-based Monitoring Through COVID-19 and Beyond

Risk-based monitoring (RBM) may be a relatively recent phenomenon, but it has become a commonly used methodology in clinical trials as evidence of its benefits …

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Virtual or Decentralised Clinical Trials
Volume 12 Issue 5

Virtual or Decentralised Clinical Trials: Defining The New Normal

Clinical trials are a cornerstone of drug development, providing scientific evidence on the safety and efficacy of novel pharmaceutical compounds. While traditional trials have effectively …

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Converting Compliance from a cost
Volume 12 Issue 5

Converting Compliance from a Cost Centre to a Critical Success Factor

Maintaining compliance can be a relentless drain on resources. Alternatively, business can make good use of the data collected for compliance to gain actionable business …

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Hybrid Remote Trials
Volume 12 Issue 5

Hybrid Remote Trials – Current Trends and Application

The global crisis caused by the coronavirus has disrupted our personal and professional lives in ways that seemed inconceivable only a fewmonths ago. This is …

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What does it Take to have a Good Experience
Volume 12 Issue 5

What does it Take to have a Good Experience of Recruitment in Clinical Research: Malaysia

A staggering number of clinical trials fail to meet recruitment goals, leading to delays, early termination, or inability to draw conclusions at trial completion due …

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Pandemic Patient Support
Volume 12 Issue 5

Pandemic Patient Support – Navigating the New Norm of Clinical Trials?

Working in the clinical trial space teaches you a lot about resilience, there is a sense of duty to get things done, and this intensifies, …

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