Authors




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.



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.


Amy Raymond, PhD, PMP

Latest:

Evolving Tools and Perspectives for the Development of Cell and Gene Therapies

Stakeholders must alter their mindsets when it comes to early-phase design and interpreting regulatory guidance for CGT trials.



Joseph Lengfellner

Latest:

Streamlining Clinical Trials with eSource: Insights from MSK

A use case by Memorial Sloan Kettering Cancer Center explores the potential of EHR-to-EDC.


Caroline Keane

Latest:

Self-collection of Blood Specimens in Clinical Trials

Operational and patient burden considerations for self-collection of blood specimens in clinical trials


Pat Larrabee

Latest:

Sites Still Necessary for Decentralized Trials

Has technology taken the industry too far?




Sanjeev Luther

Latest:

Cancer Won’t Wait for COVID to End: Conducting Trials Amid the Coronavirus Pandemic

Thousands of trials have been halted as a consequence of the coronavirus pandemic, slowing the pace of scientific progress dramatically.


Don Lazas

Latest:

5 Reasons Physicians Should Integrate Clinical Trials Into Their Practice

Using IROs can offer the opportunity for doctors to incorporate clinical research as a care option in their practices.

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