Authors


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.


Paris Adkins-Jackson, PhD

Latest:

Clinical Trials and Trust

Understanding the role of social determinants on clinical trial participation and trust.


Jayathirtha Gopalakrishna

Latest:

Establishing Metrics and Standardization for Non-CRF Data in EDC

While Case Report Forms are a main contributor to collected data, non-CRF data such as core laboratory data and central imaging can be critical to any clinical study.



Dale Hanna

Latest:

Direct-to-Patient: At-Home Clinical Trials Are Here to Stay

The success of the decentralized model hinges on coordination between stakeholders across the supply chain to ensure that date is secure, medication is delivered on time, and in proper condition.


Kristy Birchard

Latest:

Prioritizing Patients: Strategies and eCOA Best Practices in Drug Development

A more user-centered design can allow increased flexibility in the development of eCOA platforms, driving better engagement and participation.


Christoph Koenen

Latest:

Changing the Digital Health Playing Field: A New Era

Moving beyond the pill to extend the value being delivered to patients.

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