Authors


Liz Cole

Latest:

Outside-In: Why Putting Patients at the Heart of Drug Development Matters

This article delves into the why, when, and how a patient-centric approach should be adopted for both the benefit of patients and the successful development of novel and innovative medicines.


Domenico Merante

Latest:

Outside-In: Why Putting Patients at the Heart of Drug Development Matters

This article delves into the why, when, and how a patient-centric approach should be adopted for both the benefit of patients and the successful development of novel and innovative medicines.


Scott Connor

Latest:

Trends in Global Public and Patient Perceptions of Clinical Research

To inform our understanding of public and patient trust and confidence, this article provides a high-level summary of the results of two studies monitoring trends in international public and patient attitudes and perceptions.


Jim Davis

Latest:

Signal Management in Excel is Stifling Pharmacovigilance Innovation

Do users actually want to use Excel? Explore the different viewpoints behind choosing SaaS or Excel.


Meghan Oates-Zalesky

Latest:

Back to Basics? Physician Awareness and Nucleic Acid-Based Therapies

Survey data finds that physicians aren’t very familiar with the intricacies of nucleic acid-based therapies.


Mark Mesterman

Latest:

User Experience (UX) to Help Participants Find Trials on the Web

Healthcare professionals are engaged in an increasingly competitive fight to attract and retain clinical trial participants through the use of user experience (UX).


Vadim Tantsyura

Latest:

The Transformation of Clinical Trials from Writing on Papyrus to the World of Technology

New requirements must be put in place to ensure data quality and integrity.


Edward I. Ginns, MD, PhD

Latest:

Closer Pharma-Diagnostic Collaboration is Key to Alzheimer’s Drug R&D

Pharma and diagnostics companies need to strengthen alignment in Alzheimer’s disease research-to help turn science and data into actionable medical innovations.


Richard Joubert

Latest:

Cancer Trials: Raising Accrual Rates

Lessons learned from the recruitment of colorectal cander patients into clinical trials.


Deborah Thompson

Latest:

Risk-Based Monitoring Versus Source Data Verification

Pilot study compares a risk-based monitoring and remote trial management method with traditional on-site source data verification for trial oversight.


Sean Bennett, MD, PhD

Latest:

Risk-Based Monitoring Versus Source Data Verification

Pilot study compares a risk-based monitoring and remote trial management method with traditional on-site source data verification for trial oversight.


Kevin Fielman, PhD

Latest:

De-Risking Trials with Science-Driven Oversight

Identifying the ‘significant six’ areas of clinical study conduct to mitigate risk.


Lisa Danzig, MD

Latest:

Risk-Based Monitoring Versus Source Data Verification

Pilot study compares a risk-based monitoring and remote trial management method with traditional on-site source data verification for trial oversight.


Lisa Bedell

Latest:

Risk-Based Monitoring Versus Source Data Verification

Pilot study compares a risk-based monitoring and remote trial management method with traditional on-site source data verification for trial oversight.


Penelope Manasco, MD

Latest:

Risk-Based Monitoring: Barriers to Adoption

Examining the barriers, challenges, and outcomes to determine the effectiveness of different RBM implementation approaches.


Eric Herbel

Latest:

Risk-Based Monitoring Versus Source Data Verification

Pilot study compares a risk-based monitoring and remote trial management method with traditional on-site source data verification for trial oversight.


Jay McHarg

Latest:

Cold Chain as a Service

According to the IQVIA Institute for Human Data Science, the pharmaceutical industry loses roughly $35 billion annually as a result of temperature excursions, making transport one of the weakest links in many manufacturers’ supply chains.


Andrew Kinley, Ph.D.

Latest:

Multiple Expansion Cohort Clinical Trials: A Shorter Path to Success for Oncology Drugs

The rapid rise of targeted drugs and biologics in oncology has spurred sponsors and the FDA to innovate, leading to the creation of a variation to the typical trial design that can include multiple expansion cohorts.


Somaraju Lokaranjan

Latest:

Want to Ensure Trial Success? Effective Management of Internal Team Calls may be a Key

It is important to devote quality time to challenge yourself and your teams on whether there is a need to strategize and rethink the way you are conducting teleconferences for your clinical trials.


David Connelly, PhD

Latest:

The Ghost of Clinical Trials Past, Present, and Future

Have you seen many paradigm shifts lately?


Jim Streeter

Latest:

Data Dilemmas in Clinical Trials Continue

Survey uncovers key findings amid today’s explosion of data volume and sources-and the added complexity in managing clinical data.


The Michael J. Fox Foundation Recruitment and Retention Team

Latest:

Using Facebook Ads to Recruit Clinical Study Participants

First column in this series looks at the effectiveness of digital marketing as an outreach tool.


Kevin Monroe

Latest:

Q&A: Capitalizing on Technology-Enabled Clinical Research

In the following Q&A, Guillaume Marquis-Gravel, MD, and Kevin Monroe discuss the advancements and related challenges of incorporating new technological tools in drug development, including eClinical approaches currently undertaken in the foundation’s own studies.


Guillaume Marquis-Gravel

Latest:

Q&A: Capitalizing on Technology-Enabled Clinical Research

In the following Q&A, Guillaume Marquis-Gravel, MD, and Kevin Monroe discuss the advancements and related challenges of incorporating new technological tools in drug development, including eClinical approaches currently undertaken in the foundation’s own studies.


Josh Rose

Latest:

How Tech and Data Enable Patient-Centric Clinical Trials

Remote trials have the potential to increase recruitment, reduce attrition, and make patients feel more engaged with the research.


Derek Lawrence

Latest:

Non-Data Scientists: The Evolving Role of Clinical Data Management

The “citizen data scientist” is the person with no official data scientist training who uses the latest tools and technologies to handle data wrangling duties, analyze data, and create reports and models.


Yiannis Karageorgos

Latest:

Can Data from EHR Systems Be Trusted in a Trial Setting?

An increase in use of EHR systems at clinical investigative sites adds more expectations for clinical trial sponsors to comply by regulatory requirements.


Cheryl Tucker McClung

Latest:

Can Data from EHR Systems Be Trusted in a Trial Setting?

An increase in use of EHR systems at clinical investigative sites adds more expectations for clinical trial sponsors to comply by regulatory requirements.


Kelley Olree

Latest:

Can Data from EHR Systems Be Trusted in a Trial Setting?

An increase in use of EHR systems at clinical investigative sites adds more expectations for clinical trial sponsors to comply by regulatory requirements.


Ludger Bührmann

Latest:

Can Data from EHR Systems Be Trusted in a Trial Setting?

An increase in use of EHR systems at clinical investigative sites adds more expectations for clinical trial sponsors to comply by regulatory requirements.

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