Julia Sundari


Sustainability in Clinical Trials: Purposeful Digitalization is Key

Its integration is opening up more opportunities for sustainable study practices.



Strategies to Include the LGBTQIA+ Community in Research Trials

Recently there has been an increase and awareness of the long-standing problems with diversity and the inclusion of under-represented populations in clinical research.

Cathy Zeanah


Strategies to Close the Gap in Clinical Trial Recruitment

2021 survey highlights challenges and opportunities for investigators, coordinators, and patients.

Ashutosh Pachisia


AI/ML Approaches to Assisted Medical Writing—Part 2

Following a discussion around summarization in Part 1, Part 2 discusses the method of pure abstraction in light of recent advances in deep learning and AI.

Emily Botto; Ruby Madison Ford, MPH; Hana Do, MPH; Ken Getz, MBA


Patient and Site Personnel Perceptions of Retail Pharmacy Involvement in Clinical Research

Despite industry-wide excitement over the involvement of retail pharmacies in clinical research, there is little information currently available on how retail pharmacies are perceived by investigative sites and patients.

Dr. Mark Travers


Redefining CRO Sourcing Model Terminology to Optimize Outsourcing Strategies

Differentiating FSO and FSP approaches can better align definitions of models for CROs and sponsors.

Chris Moore


Accelerating Time to Treatment in Rare Disease

Life sciences leaders are overcoming challenges to speed the development, launch, and education of novel medicines for rare diseases.

Srinivasan Anandakuma


Dialogue with Your Data: Conversational Experience Is the New User Experience

With an AI-enabled virtual assistant as part of your clinical research toolkit, deriving insights from clinical data is as simple as asking a question.

Venkatraman “Bala” Balasubramanian, PhD


GenAI Use as a Co-Pilot for Regulatory Intelligence

GenAI is on the precipice of making regulatory strategists more efficient by alleviating challenges, streamlining regulatory research and submission processes.

Michael Pace, PhD


The Benefits and Limitations of Clinical Data Platforms

Considerations to help tailor new tools as part of a custom clinical trial strategy.

Robert Feltz


Trends Impacting Clinical Trial Supply Management

Insights on leveraging outsourcing partners to gain expert, streamlined, and personalized support.

Rose Higgins


Radiomics in Action

The intersection of academic research and clinical trials.

Jennifer Y. Kim; Ruby Madison Ford; and Zhida Shang


Mapping Baseline ChatGPT Usage to Support Drug Development

Despite limitations to its widespread use within healthcare, there is great potential for ChatGPT’s application in drug development.

Rohit Nambisan


New Legislation is Driving Diversity in Clinical Research

Industry leaders discuss how technology can help companies adapt to the regulatory changes and accomplish their DE&I goals.

Thread Research


How Decentralized Clinical Trial (DCT) Design Brings Clinical Research as a Care Option to Cancer Patients

Esther Howard, Oncology Advisor at THREAD, will be shedding light on how DCT design brings clinical research as a care option to cancer patients. In 2021, over 608,000 Americans alone passed away from cancer- equating to 1,600 deaths a day. Because clinical trials become the only treatment option for cancer patients after they have exhausted all standard of care options, we desperately need solutions to bring real access to clinical trials as a care option to more cancer patients. Esther will focus on some of the challenges that patients face, and how elements of a DCT design can not only save the lives of more patients but can also be a key driver in improving diversity in enrollment.

Christian Rubio


Diversity in Clinical Trials: Path to Achieving Health Equity

Beyond technology, awareness, and access—cultural competence is key.

Tzvia Bader


AI Addresses the Complexities of Cancer Trials for Patients and Pharma

Study designs, coupled with difficulties finding, enrolling and retaining trial participants, further intensify operational challenges and prevent new treatments from getting to market.

Craig Mooney


Getting IRT Right – Part 2: Study Drug Allocation and Supply Management

In an earlier article, we reviewed the randomization risks that could arise if an interactive response technology (IRT) system isn’t designed and/or implemented correctly. Here we address the consequences that trial sponsors could face if their IRT system isn’t adequately designed to handle the many and often complex drug allocation and trial supply aspects of their clinical trials.

Katrina Rice


What the Future State Really Looks Like for Clinical Data Leaders

Accelerating trends in clinical data are forcing changes in strategy.

William Chaplin


Adapting Site Selection for Clinical Trial Decentralization and the Future Landscape

Sites not expected to fade away even as DCTs continue to grow past COVID-19.

Sylviane de Viron


Quality Tolerance Limits: An Updated View of Industry Trends

New data shows the adoption of studies introducing quality tolerance limits continues to surge—and offers clues on focus of implementation.

Arthur H. Rubenstein, MBBCh


We Must Do More to Ensure Women Achieve Their Professional Goals

With poor retention of women in the biomedical workforce amid the pandemic, industry leaders in clinical research must step up to provide solutions.

Haixue Wang


The Regulatory Requirements and Key Points of Drug Clinical Trials Registration in China

Following the implement of new Drug Registration Regulation in July 2020, the clinical trial registration system will have some major changes in China.

Anthony J. Mahajan


Are You a Victim of Clinical Trial Fraud? If So, What Are Your Rights and Obligations?

Aggressive focus by DOJ has put increased burden on stakeholders to understand their obligations and exposure.

Marcus A. Banks


Clinical Trial Technology: New Kids on the Block are Changing Industry Dynamic

COVID has accelerated to the scene upstart digital efforts to transform patient engagement and data management/integration—but progress remains measured.

Pratibha Potare


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.

Jacob Braude


How Sponsors Can Use Health Decision Science to Improve Clinical Trial Recruitment and Retention

Examining the behaviors of clinical trial stakeholders to better understand challenges in patient participation.

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