Authors


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.


Keri Mattox

Latest:

Empowering the Workforce of the Future: The Trends and Training That Will Drive the Future of Drug Development

A new global report finds that clinical research teams are making progress but still lack the skills and tools needed to keep pace with growing trial complexity and emerging technologies.


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.


Kirk Wroblewski

Latest:

Applied AI and Advanced Automation in Clinical Trials

Use cases spotlight the growing potential of generative AI in the CRO space.



Joseph Lengfellner

Latest:

Scaling eSource-Enabled Clinical Trials: Hospital Perspectives

The challenges, opportunities, and strategic outlook for oncology research centers.


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.


Scott Gray

Latest:

Streamlining Clinical Trials: Mitigation and Management

How service providers are helping to accelerate drug development.


John Corcoran

Latest:

At-home Self-collection of Blood Specimens for Safety Lab Testing in Clinical Trials via the Tasso+ Device

Laboratory services organization focuses on easing patient and site burden with improved collection device.


Devin Solanki

Latest:

From Quality by Constraint to Quality and Choice

How management of trials must evolve.


Ralph Passarella

Latest:

What Do COVID-19 Vaccine Timelines Mean For Clinical Development?

The pandemic spurred an urgency to innovate that improved clinical development in ways that should benefit the industry beyond COVID-19.


Herman Pieterse

Latest:

Towards a Global Implementation of eConsent in Clinical Trials

All stakeholders must play part in increasing implementation.


Inga Rose

Latest:

America’s Vanishing Scientific Research Workforce is a Threat to Public Health

As biotech innovation accelerates, the clinical research workforce is rapidly eroding—threatening the future of drug development. From workforce burnout to training program cuts and talent pipeline collapse, clinical trial professionals must confront this escalating crisis head-on to sustain progress and protect public health.


Jennifer Visser-Rogers

Latest:

Creating Strategic Relationships: The Changing Face of Contract Research Organizations and Sponsor Partnerships

By taking on tasks such as clinical trial management, logistics, statistics, and data management, contract research organizations have helped expand the capabilities of their sponsor partners and accelerate drug development timelines.


Shaena Kauffman

Latest:

Helping Rescued Adjudication Committees Get Back on Track

Determining if an EAC is at risk and key actions to mitigate trial impact.


Matt Simmons

Latest:

Where Innovation and Patients Meet to Improve Cancer Care

Promising scientific advances are pacing oncology drug development.


Kevin Venner

Latest:

Clinical Trial Monitoring: Should Randomization Be Included?

While randomization is required by regulatory bodies, it is up to the sponsor on how to conduct it.


Alan Marcus

Latest:

Changing the Paradigm in AI Implementation

How pharma companies can reduce the risk of failure with AI-based innovations.


Marjorie E. Zettler, PhD, MPH

Latest:

FDA’s New Diversity Plan Guidance, And What It Means for Sponsors Developing Cancer Drugs

Guidance will compel sponsors to consider new enrollment strategies and to be more diverse.


Ramita Tandon

Latest:

Community Pharmacies Can Help Bridge the Diversity Gap

Through grassroots patient education, local pharmacies serve as a pivotal doorway to improving access to trials.


Krithika Shetty, PhD

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.

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