Authors


Matthew Ryan

Latest:

Unleashing Their Potential: The Evolving Landscape of DHTs

Key considerations in deploying fit-for-purpose digital health technologies in drug development.


Navjot Kaur, PhD

Latest:

Managing Biospecimens in Cell and Gene Therapy Trials

Pursuing new tools and capabilities in sample logistics, storage, and data analysis.


Mike Straus

Latest:

Patient Recruitment Goes High-Tech

Emerging tools in data analytics, automation, EMR aggregation, and even social media are enabling faster and easier patient recruitment.


Lamine Mahi

Latest:

COVID-19 Pandemic Exemplifies the Benefits of CROs

The adaptability and innovative capacity of CROs highlighted in EUCROF survey.


Raja Shankar

Latest:

Leveraging AI/Machine Learning as an End-to-End Differentiator

A well-designed approach can benefit clinical trials from protocol design to site support.



Marc Rothman, MD

Latest:

Patient-Tested Practices for In-Home Trials

Bringing clinical trials to patients’ homes can address existing site-based challenges.




Manfred Stapff, MD, PhD

Latest:

The Importance of Real-World Evidence in Medical Research and Drug Development

The ongoing evolution of real-world evidence from a novel concept to a cornerstone of modern medical research signifies its growing importance and vast potential to improve personalized medicine, overall healthcare outcomes, and eventually democratization of scientific facts by general accessibility.


Marcelo Alves Favaro

Latest:

Enabling Evidence-Based Study Endpoint Selection

Harnessing advances in digital health technologies for a more precision-measured approach.



Christine Nelson

Latest:

Teamwork for Better Healthcare Solutions: Merging Clinical and Marketing Efforts

In the ever-evolving landscape of healthcare, it's vital for organizations to take steps toward bridging the gap between their clinical and marketing teams.


Yudong Zhao, PhD

Latest:

Harnessing the Power of Scientific Surveillance

Statistical methods used via this technique in centralized monitoring.


Kevin T. Fielman, PhD

Latest:

Oversight Method Identifies Critical Errors Missed by Traditional Monitoring Approaches

Study Health Check provides early identification of issues related to protocol deviations and determines objective measures of site-specific versus study-wide performance.



Scott Scarola

Latest:

Orchestrating Different Levels of a Successful Clinical Study Start-Up

Similar to a world-class symphony, a curated site start-up model can accentuate its individual components and lead to swift starts for clinical trials.


Melissa Hutchens

Latest:

The Transformative Power of Data Analytics in Clinical Trials

Leveraging and benchmarking insights to boost efficiency and optimization.



Olivier Lantrès

Latest:

COVID-19: A New Era for Clinical Trial Research in Europe?

A look at the issues in Europe affecting ongoing trials including data management, measures being taken by sponsors, and more.


Ally Hochman

Latest:

Implementing ePROs in Arthritis Clinical Research

The value of electronic patient-reported outcomes data in this disease setting.



Drew Bustos

Latest:

5 Strategies for Bridging the Sponsor-Site Tech Divide

Results from survey of 100 site personnel suggest a disconnect is present between these stakeholders.


Goonaseelan (Colin) Pillai

Latest:

Africa is Biosimulation’s Next Frontier

The answers to meeting biosimulation's growing demand for talent may lie in Africa.


Gabriel Bohl, PharmD, FTOPRA

Latest:

Regulatory CMC: Enhancing Biologics Development

Preventing delays and accelerating the progression of these critical therapies.


Aman Khera

Latest:

Using Digital Technology to Empower Patients and Restore Trust

Looking at the road ahead to properly utilizing digital technology in clinical trials.


Tina Caruana

Latest:

The Impact of Decentralized and Hybrid Trials on Sponsor and CRO Collaborations

Tufts CSDD study in collaboration with ten biopharmaceutical organizations and CROs examines sponsor/CRO relationships.


Deepika Khedekar

Latest:

COPD: Therapies on the Cusp

Clinical trials in this area reflect new science, and corresponding challenges in their execution.


Jess Ross, PhD

Latest:

Beyond the Black Box: Tailoring AI Regulation in Healthcare

As adoption increases, regulatory bodies are becoming more involved in the oversight of artificial intelligence.


Peter M. O’Neill

Latest:

A Digital Twin on CAR-T Cytokine Release Syndrome (CRS) Patients with Standard of Care Measured by CRS Distribution by Grade

Using existing clinical trial data to proactively model patient safety and efficacy outcomes could aid in accelerating development for areas in need of new therapies.

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