Authors


Ryan Bailey

Latest:

The Importance of Age Diversity in Clinical Trials

Age diversity in clinical trials benefits both the patient experience and the success of the trial.


Mindy Gruba

Latest:

Patient Engagement Surveys in Clinical Trials: Dos, Don’ts and How They Help

This article will address concerns and look at how the pragmatic implementation of surveys in today’s clinical trials can provide valuable insight into patient satisfaction levels, motivators, likelihood to follow study requirements and information retention.


An Nguyen

Latest:

How to Avoid Common Pitfalls of Market Landscaping

Key tips and resources to help evade the common traps of market landscaping-today an increasingly high-stakes and comprehensive task during clinical development.


Crissy MacDonald, PhD

Latest:

New ICH Guidelines Address Industry Inefficiency

In this article, Crissy MacDonald reviews the key changes in ICH E6 (R2), discuss the challenges organizations are facing, and present actionable recommendations for organizations to implement now.


Aidan Gannon

Latest:

Using Feasibility Tools to Build Better Sponsor–Investigator Relationships

Feasibility, the evaluation of whether a particular trial can recruit enough of the right patients so that the study completes on time and within budget, is arguably the most critical part of the clinical trial process.



Viren Konde

Latest:

Recent Trends in Clinical Trials for Coronary Diseases

In this study, Clinical Trials Transformation Initiative’s database for aggregate analysis of ClinicalTrials.gov was used to evaluate the number of ongoing and completed interventional clinical trials for various coronary diseases.


Barry S. Sall, Angela X. Qu, MD, PhD

Latest:

Navigating the Complexities of Drug-Biomarker Co-Development

Success in developing targeted medicines means companies need a companion diagnostic strategy, the expertise, and more.


Bernard Fermini

Latest:

Clinical Trials In a Dish: A Revolution Begins

The emergence of CTiD offers the potential to remove future clinical failures much earlier in the process-and pave way for gains in R&D productivity.


Shawn T. Coyne

Latest:

Clinical Trials In a Dish: A Revolution Begins

The emergence of CTiD offers the potential to remove future clinical failures much earlier in the process-and pave way for gains in R&D productivity.


Kevin P. Coyne

Latest:

Clinical Trials In a Dish: A Revolution Begins

The emergence of CTiD offers the potential to remove future clinical failures much earlier in the process-and pave way for gains in R&D productivity.


Tammy D’Lugin-Monroe

Latest:

Challenging the ‘Site-first’ Status Quo in Patient Enrollment

Case study highlights a new patient-centric enrollment model that uses a data-driven approach to identify qualified patients first.


Daniel Brunwasser

Latest:

Challenging the ‘Site-first’ Status Quo in Patient Enrollment

Case study highlights a new patient-centric enrollment model that uses a data-driven approach to identify qualified patients first.



Jonathan Palmer

Latest:

The Future of Mobility and Medicine

The role of the cloud in realizing the practical benefits of mHealth in clinical trials.


Nisha Dodeja

Latest:

The Status of Ebola Vaccines

Market players working on development of vaccines to fight against the virus are focused on clinical trials and look forward to gaining approval from regulatory bodies.


Jessica Langbaum, PhD

Latest:

Designing and Executing a Gene Testing Counseling and Disclosure Process

Alzheimer's Prevention Initiative's discusses a genetic counseling and disclosure model for its Generation Program.


Julie Bullock, PharmD

Latest:

FDA’s Project Optimus Guidance: Highlights and Tips for Success for Oncology Drug Developers

January 2023 guidance from FDA on dosages in oncology provides further context on expectations with Project Optimus.


Marc Pfister, MD, FCP

Latest:

Leveraging Modeling & Simulation in Oncology

How the use of M&S in cancer trials from the outset can help address those critical “what if?” scenarios and accelerate oncology drug development.


Peter Wasswa, MD

Latest:

Pediatric Oncology Clinical Trials in Sub-Saharan Africa

The region is significantly underrepresented in clinical development activity targeting childhood cancer.


Krista Armstrong

Latest:

Complex, Puzzling, Ill-Defined: Challenges in Assessing PTSD

A recurring challenge in assessing and treating Post-Traumatic Stress Disorder or PTSD is the inherently complex, ill-defined, and sometimes downright puzzling nature of its symptoms.


Olive McCormick

Latest:

Why Data Integrity Should be an Integral Part of the Pharma Biotech Industry Culture

Data integrity is the essence of GMP, the cornerstone of how the industry operates, and it is vital that all organizations embrace it to survive the rapidly changing life sciences landscape.


Grace Maria Antony

Latest:

Categorical Data Analysis

A review of different statistical methods for data types and models used during research.


Norafizaa Yusop

Latest:

Evolution of Clinical Trial Agreement Review in Malaysia Through Clinical Research Malaysia

A reduction of Clinical Trial Agreement Review times has caused rapid development in Malaysian clinical trials.


Nurul Atiqah Abd Rahman

Latest:

Evolution of Clinical Trial Agreement Review in Malaysia Through Clinical Research Malaysia

A reduction of Clinical Trial Agreement Review times has caused rapid development in Malaysian clinical trials.


YPrime

Latest:

Advancing Oncology Drug Development with ePRO Solutions

For drug developers, oncology therapeutics arguably represent both the greatest opportunity and challenge for putting patients at the center. This ebook covers series strategies for Advancing Oncology Drug Development with ePRO Solutions.


Jessica Rine

Latest:

How Data and Analytics Can Improve Clinical Trial Feasibility

These seven key building blocks for success are outlined to help companies develop and implement a data-and-analytics-driven approach to clinical trial feasibility.


Sharma Ramanathan Deva Devesa

Latest:

4 Key Actions ClinOps Can Take Now to Avoid Disruptions

Biopharmaceutical sponsors should make urgent decisions now to plan for continued clinical research in the coming months.


Indu Menon

Latest:

Medical Coding Procedures in Clinical Research: An Amarex Safety and Pharmacovigilance Perspective

This article will detail how the Amarex Safety & Pharmacovigilance team performs medical coding using an internally developed safety platform.


Nkem Olanrewaju

Latest:

Medical Coding Procedures in Clinical Research: An Amarex Safety and Pharmacovigilance Perspective

This article will detail how the Amarex Safety & Pharmacovigilance team performs medical coding using an internally developed safety platform.

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