Authors


Frederick Lewis

Latest:

Placebo Effect of Transdermal NSAIDS

The implications and challenges of the placebo effect on regulatory agency product approval.


Scott Kolodny, MD

Latest:

Safety Considerations for Follow-On Non-Biologic Complex Drugs

With patents for many NBCDs soon to expire, the need for regulatory guidance regarding follow-on versions of these products is crucial.


Dian Griesel, Ph.D.

Latest:

Clinical Trial Recruitment in the Digital Era: Some Smart Ideas

Challenging. Time-consuming. Expensive. Do words like these spring to mind when you contemplate the patient recruitment process for your clinical trials?


Sponsored Content

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Optimizing Clinical Trials Using Electronic Measurement and Analysis of Drug Adherence

Drug development has never before been so difficult, time consuming and expensive. Accuracy in clinical trials, therefore, is a priority



David Sahner, MD

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Machine Learning, Modeling, and Predictive Analytics: Key Principles for the Clinical Scientist

With the inherent limitations of traditional data sources, this overview explores the definitions and strategic fundamentals that inform machine learning and modeling techniques.


Vincent Schroyens

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Is There a Link Between Recruitment and Social Media?

A survey of Belgian clinical research professionals offers insights into the future of social media


Jessica Van Den Broeck

Latest:

Is There a Link Between Recruitment and Social Media?

A survey of Belgian clinical research professionals offers insights into the future of social media


Yves Geysels

Latest:

The African Medicines Agency: Impacts on the Continent’s Clinical Trials Regulation

Harmonization could turn the continent into an established site for clinical research and laboratories.




Arthur Wang

Latest:

Cloud Computing: Security in Clinical Trials

There is a lot of buzz about “the cloud.” Formally known as cloud computing, the cloud relies on sharing of Information Technology (IT) resources.


Wendy Tate

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A Critical Piece of the Research Puzzle: How Metrics Have Transformed Clinical Trials

Three key insights about clinical trial advancements made possible by the advent of metrics


Adrian Wildfire

Latest:

Human Challenge Studies in Early Phase Antiviral Development

The concept of the human challenge model (HCM) originated from early societal attempts to halt the spread of acute diseases within their own communities


Jonathan Rowe, PhD, MS, MA

Latest:

The Eradication of False Signals in Monitoring

How optimizing RBQM risk detection reduces the efforts caused by false signals.


Lori McKellar

Latest:

Targeting eTMF for Efficiency and Productivity Gains

In clinical trials, the ability to effectively plan, collect and maintain essential clinical trial documentation is challenging.


Paul Donnelly

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Expanding Data Management Services in China

EDC has become the data management platform of choice around the world, offering advantages such as increasing the quality and timely collection of data. Medrio, an EDC company that offers eClinical software solutions, has quoted that 70% of clinical trials are using EDC as a forms of collecting data in the United States. In China, we have seen adoption rates for EDC increase dramatically in recent years, fuelled by improved technology developments in mobile applications, and the increasing experience with EDC usage in clinical research.


Craig Morgan

Latest:

Millennials and their Impact on Clinical Research

The importance of examining this generation’s influence on the clinical trial value chain.


Katherine Ni

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The Employee Profile in China Pharma R&D

In this analysis, distinctions between who hires who in non-Chinese and China-based companies emerges.


Mathini Ilancheran

Latest:

Impact of Actigraphy in Clinical Research

With all the buzz around wearables, actigraphs-which monitor sleep and daytime activity levels-have been around for decades.


Juanjo Cardona

Latest:

The Employee Profile in China Pharma R&D

In this analysis, distinctions between who hires who in non-Chinese and China-based companies emerges.


Denise Calaprice-Whitty

Latest:

Bridging the Gap for Better Patient Engagement

A survey from the Avoca Group examines issues related to quality of clinical trials and trial participation from the patients' view.


Jeffry Liu

Latest:

Considerations for Clinical Trial Design in Public Health Emergencies

While the fundamental concerns behind the design of most modern clinical trials are effectively the same, clinical trials that take place during public health emergencies face additional layers of challenges.



Elizabeth Dalton

Latest:

Five Steps to Increase Site Satisfaction and Study Success

Over the past three decades, clinical imaging has become an integral part of the drug development process for biopharmaceutical companies.



PAREXEL

Latest:

FSP Partnership: A Foundation for Innovation and Patient-Guided Development

Liz Rogers, VP and Head of Global Site and Study Operations at Pfizer, discusses Pfizer's partnership with Parexel and transition to a functional service provider (FSP) model.


Murray A. Abramson, MD

Latest:

Outsourcing Strategies and Practices to Improve Efficiency and Performance

Demand for outsourced services to provide clinical development capacity and expertise has grown substantially over the last 10 years.


Frances Grote

Latest:

Outsourcing Strategies and Practices to Improve Efficiency and Performance

Demand for outsourced services to provide clinical development capacity and expertise has grown substantially over the last 10 years.


Bernadette Tosti

Latest:

Improving Minority Recruitment in Clinical Trials

Promising new approaches to optimize data and outcomes.

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