Authors


WCG IRB

Latest:

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

Latest:

Strategies to Close the Gap in Clinical Trial Recruitment

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


Ashutosh Pachisia

Latest:

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.


Dr. Mark Travers

Latest:

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

Latest:

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

Latest:

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

Latest:

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

Latest:

The Benefits and Limitations of Clinical Data Platforms

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


Rose Higgins

Latest:

Radiomics in Action

The intersection of academic research and clinical trials.


Rohit Nambisan

Latest:

The Future of Clinical Trials: Turning Data Chaos into Trial Intelligence

Poll taken by leading biotech executives in clinical development addresses state of data quality and management.


Thread Research

Latest:

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

Latest:

Diversity in Clinical Trials: Path to Achieving Health Equity

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


Tzvia Bader

Latest:

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

Latest:

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

Latest:

What the Future State Really Looks Like for Clinical Data Leaders

Accelerating trends in clinical data are forcing changes in strategy.


William Chaplin

Latest:

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

Latest:

Using Machine Learning and NLP to Improve Central Monitoring Documentation

Study teams often face challenges in maintaining detailed and accurate documentation of risk signals.


Arthur H. Rubenstein, MBBCh

Latest:

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

Latest:

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

Latest:

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

Latest:

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

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.


Jacob Braude

Latest:

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.



Guy Rachmuth, PhD

Latest:

Self-collection of Blood Specimens in Clinical Trials

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


Anna Baran, MD

Latest:

Oncolytic Virus Immunotherapy: A Brief Overview and Considerations for Clinical Trial Planning

Successful oncolytic virus immunotherapy clinical development requires unique features that focus on viral biology and host immune response.


Maria DiPietro

Latest:

Outsourcing Model Usage and its Relationship to Clinical Trial Performance

Pilot study seeks to validate new and more granular outsourcing model classifications in differentiating performance across custom contract-service approaches.

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