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Demand-led Supply: Increasing Efficiency in Clinical Studies Logistics
Editorial Archive

Demand-led Supply: Increasing Efficiency in Clinical Studies Logistics

Cost pressures associated with the development of new medications are at an all-time high for the pharmaceutical industry. Drug development costs in general are risin...
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How Integration of Consumer and Medical Devices is Reshaping Clinical Trials
Editorial Archive

How Integration of Consumer and Medical Devices is Reshaping Clinical Trials

The advent of continuous data monitoring using wearable technology and other connectable medical devices has opened the door to new insights into the lives of patient...
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Why would Cardiovascular Outcomes Trials and Rare Disease Studies have Anything in Common?
Editorial Archive

Why would Cardiovascular Outcomes Trials and Rare Disease Studies have Anything in Common?

Cardiovascular outcomes trials (CVOTs) are some of the largest interventional trials being conducted, enrolling several thousand subjects, sometimes with follow-up of...
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Bridging the Clinical Data Structure Gap to Empower Holistic Risk Management
Editorial Archive

Bridging the Clinical Data Structure Gap to Empower Holistic Risk Management

Per the suggestion of regulatory agencies, there is an increased focus on the merits of adapting a risk-based monitoring (RBM) approach. Effective RBM reduces costs, ...
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Why and How a Research Lab Should Embrace Research Quality
Editorial Archive

Why and How a Research Lab Should Embrace Research Quality

The development of therapeutic products balances benefits and adverse consequences, so research quality is required for the development of the new therapeutic. Astute...
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Latest FDA Guidance on Non-Inferiority Designs
Volume 9 Issue 1

Latest FDA Guidance on Non-Inferiority Designs

To obtain drug approval from the US Food and Drug Administration (FDA), manufacturers must establish efficacy by providing “substantial evidence” of effectiveness fro...
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Integrative Approach to the Conduct of Rare Disease Clinical Trials
Editorial Archive

Integrative Approach to the Conduct of Rare Disease Clinical Trials

The planning and execution of rare disease clinical trials involves unique considerations. Examples include the role of patient advocacy groups, the value of outcomes...
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Human Challenge Studies: An Effective Tool for Drug Development
Editorial Archive

Human Challenge Studies: An Effective Tool for Drug Development

Human challenge studies (HCS) were introduced as an alternative to community clinical trials for anti-infective agents and vaccines, previously performed in regional ...
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Policy 0070 Under the Microscope: The Trade-off Between Clinical Trial Transparency and the Risk of Revealing Patient Identities
Editorial Archive

Policy 0070 Under the Microscope: The Trade-off Between Clinical Trial Transparency and the Risk of Revealing Patient Identities

The last few months have seen a battle build between the pharma industry and the EMA, following the issue of new guidance promoting greater transparency in clinical t...
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Five Reasons to Embrace the ICH E6 (R2) Addendum Now: Improve Study Efficiencies by Centralising Risk-based Quality Oversight and Trial Management
Editorial Archive

Five Reasons to Embrace the ICH E6 (R2) Addendum Now: Improve Study Efficiencies by Centralising Risk-based Quality Oversight and Trial Management

In November 2016, the ICH E6 (R2) Addendum to Good Clinical Practice was implemented, delivering a breath of fresh air for clinical trial sponsors and CROs who have b...
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