Authors


Dr. Steve Winitsky, MD

Latest:

Effective regulatory strategies for rare disease

In the rare disease issue of New Medicines, Novel Insights from Parexel, experts and former regulators share insights for developing effective regulatory strategies earlier.


Bhavish Lekh

Latest:

Beyond the Horizon: A New Era for Faster, Smarter Clinical Trials

Current industry trends align with the need for improved, fit for purpose technology.


Apurva Bhingare

Latest:

Employing the Power of Bayesian Methods to Expedite Learning

Bayesian methods bring flexibility and speed to clinical trial design and analysis, and with increased access to the necessary computational power, are transforming today’s clinical research.


Derk Arts, MD, PhD

Latest:

How Pharma Needs to Prepare for the Next Pandemic

Master protocols helped accelerate research during the pandemic in the EU. How can US companies learn from this and start preparing master protocols now?


Kathleen Killen

Latest:

Tailored Patient Involvement in Clinical Trials

The approach of the Cancer Research UK Centre for Drug Development.


James Moat

Latest:

The Evolution of CRO and Sponsor Relationships

Exploring the 11 key ‘warning signs’ that could impact partnership success.


Tony Carita

Latest:

A New Approach to Risk Balanced Contracting

In a complex world of global clinical trials where execution is riddled with uncertainty, how should sponsors and providers approach and achieve a balance of risk and reward?


Serge Bodart, MS

Latest:

Integrating Technology and Expertise

Phase I/II study in cancer patients showcases eClinical effectiveness.


Ryad Ramda, MS

Latest:

Accelerating Clinical Trial Design and Operations

Fully-integrated, component-based CDMS offers flexibility, customization, and efficiency.


Hugo Geerts, PhD

Latest:

Upping the Ante for Predicting the Success of Alzheimer Disease Treatments

The use of modeling and biosimulation can help predict potential outcomes and improve confidence in therapeutic candidates for Alzheimer disease.


Nicole Palmer

Latest:

10 Questions to Consider With eTMF Vendor Selection

The many different shapes and sizes of vendors requires a thoughtful process for selection.


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.


AliveCor

Latest:

Beyond the Checkbox: How Rethinking Your Cardiac Monitoring Approach Can Dramatically Improve Trial Outcomes

AliveCor knows that cardiac safety is critical, with concerns often driving drug withdrawals from trials and the market. Our solutions go beyond compliance to boost regulatory trust, data integrity, and trial success. As the only company offering integrated 6L and 12L ECGs, we provide comprehensive monitoring—onsite and remotely—to meet complex cardiac requirements. Our innovative tools empower sponsors and CROs to control trial data, enabling faster, smarter decisions throughout the research lifecycle.


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.


© 2025 MJH Life Sciences

All rights reserved.