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Artificial Intelligence and Machine Learning
Volume 12 Issue 6

Artificial Intelligence and Machine Learning Combine to Streamline Data Management in Clinical Trials

Technology advances are becoming more and more sophisticated, particularly in data management for clinical trials. But despite how advanced these technologies become, clinical trials depend …

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Dealing with the Data Flood in Clinical Studies
Volume 12 Issue 6

Dealing with the Data Flood in Clinical Studies

Managing clinical trials requires the coordination of many processes and mastering of large amounts of information under huge time pressure. In addition, increasingly complex regulatory …

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Advancing Clinical Trials through Artificial
Volume 12 Issue 6

Advancing Clinical Trials through Artificial Intelligence: A Legal Perspective

The current health crisis and the pharmaceutical industry’s subsequent efforts to develop new treatments and vaccines forCOVID-19 have brought the complexities of clinical research and …

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Minimising Risk and Maximising Efficiency
Volume 12 Issue 6

Minimising Risk and Maximising Efficiency by taking a Strategic Approach to Comparative Trial Supply

Widely acknowledged to be a prerequisite for formulary listing and even successful licensure, comparator drugs and co-therapies are used within an estimated two-thirds of clinical …

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A New Twist in the Brief History of the cardiac
Volume 12 Issue 6

A New Twist in the Brief History of the Cardiac Safety Regulations

An Update of the ICH- E14 and S7B 2000 Q&A Revision Cardiac toxicity of pharmaceuticals, primarily drug-induced proarrhythmia and the risk of sudden cardiac death, …

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Assessing Cardiac Safety in Oncological Drug
Volume 12 Issue 6

Assessing Cardiac Safety in Oncological Drug Development

Advances in the development of anticancer drugs have decreased mortality rates for many cancers and increased patient survival. However, concerns have been raised about possible …

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Commentary_On the Revised ICH E14 and S7B Q&As
Volume 12 Issue 6

Commentary: On the Revised ICH E14 and S7B Q&As

The International Council on Harmonisation (ICH) released a new set of questions and answers (Q&As) for ECH E14 and ICH S7B in August 2020. On …

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