Authors



Daniel O’Keeffe

Latest:

Harnessing Technology and Adopting Unified Approaches to Optimize Pharmacovigilance Activities

How digital intake solutions driven by technological advancements can help overcome the challenges of operating across different regulatory markets.


Leonard Lichtenfeld, MD

Latest:

Rise of the Activated Patient During COVID—Biopharma on Notice

Sparked by the pandemic, patients are now leveraging remote technology to take control of their healthcare.


Caprice Sassano

Latest:

Enabling Evidence-Based Study Endpoint Selection

Harnessing advances in digital health technologies for a more precision-measured approach.


Mark Brown

Latest:

Shifting Perspectives on Site Networks to Create Positive Change

Evaluating the lessons learned about trial sites from COVID-19 to form new strategies and improve patient safety for the future.


Angela De Martini

Latest:

COVID-19 Will Have a Heterogeneous Impact on Clinical Trials, Biopharmas

A discussion of how the coronavirus pandemic will have a multitude of impacts on the conduct of trials, as well as on the industry itself.


Patricia Roselle

Latest:

Introducing PALADIN

First-of-its-kind consortium dedicated to accelerating new medicines development through optimizing patient advocacy group—industry collaboration.


Niven Narain, PhD

Latest:

AI-Enabled Clinical Trials: A Multiomic Roadmap to Success

How artificial intelligence can aid in selecting patients, leveraging safety insights, and optimizing combination therapies.


Susan Vallow

Latest:

Demystifying Submissions of eCOA Documentation for Ethics Review: Are We Making Submissions More Difficult than Necessary?

Examining how to optimizing the time and effort of Ethics Committees to efficiently and effectively fulfill their human subjects protection remit.


Lauren Garson

Latest:

Moving Beyond the Checkbox Approach With Risk-Based Quality Management

With risk-based quality management (RBQM), the industry is uniquely positioned to amend Murphy’s Law and propose something new—“Everything that can go wrong, we can work to identify and prevent.”


Sudipta Chakraborty, PhD

Latest:

Sharing Clinical Trial Results with Pediatric Participants

Survey uncovers pediatric-patient perspectives on plain language summaries.


Monica Chmielewski and Alexandra Maulden

Latest:

An Overview of FDA Diversity-Related Documents for Clinical Trials

There is significant potential in decentralized models and digital health technology to expand diversity in clinical trials.


BRANY

Latest:

Critical Questions to Ask Your IRB

Find out if you’re working with the right IRB.


Emma Meagher, MD

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.


Sarah Burge

Latest:

Scaling eSource-Enabled Clinical Trials: Hospital Perspectives

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


DJ Tang, PhD

Latest:

Turning a Struggling Clinical Trial Around

How to assess common obstacles for opportunity and create more agile and adaptive clinical trials.


AutoCruitment

Latest:

Better Qualification Strategies, Better Patient Recruitment Outcomes

As the clinical trial recruitment landscape continues to evolve, patient recruitment remains a critical challenge. More innovative screening strategies can improve recruitment and enhance the quality of clinical research.


Dr. Varun Mishra

Latest:

Managing Clinical Trials During the COVID Pandemic

How one CRO in India quickly implemented processes and technology to mitigate risk


Katie Shaw

Latest:

Notable Discussions from SCOPE 2025: Aiming to Calculate, Accommodate, and Innovate for Enhanced Drug Development

This year’s conference highlighted a number of critical areas in clinical R&D including financial management, representation, and eCOA.


Susan Wood, PhD

Latest:

How COVID is Forcing a Reckoning in Respiratory Clinical Trials

Pandemic has brought new sense of awareness to respiratory diseases and clinops.


Martine Dehlinger-Kremer, PhD

Latest:

COVID-19 Pandemic Exemplifies the Benefits of CROs

The adaptability and innovative capacity of CROs highlighted in EUCROF survey.


Blaine Cloud, PhD

Latest:

Where Do We Go From Here?

Lessons from six months of conducting clinical trials during the COVID-19 pandemic


Jennifer Kim, Keith Maddox, Madison Ford, and Marissa Hill

Latest:

What Does Racial Color-Blindness Mean for Clinical Trial Participation?

Research collaboration between Tufts and the Society for Clinical Research Sites explores the prevalence of this belief in healthcare.


Ernest Odame

Latest:

Establishing a Basis for Secondary Use Standards for Clinical Trials

Study seeks to understand how different forms of data meet the needs of researchers.


Jiang Li

Latest:

The Future of Cardiac Safety: How Wearable ECGs Enhance Patient Monitoring in Drug Trials

As wearable ECG technology advances, cardiac safety studies in clinical trials are evolving to capture richer, continuous heart data while reducing patient burden.


Bethany Newell

Latest:

Tailored Patient Involvement in Clinical Trials

The approach of the Cancer Research UK Centre for Drug Development.


David Forster, JD, MA, CIP

Latest:

Reviewing FDA’s Proposed IRB and Informed Consent Rule Changes

21st Century Cures Act prompts FDA to harmonize regulations.


Jessica Jarvis and Daniel Blessing

Latest:

Scale Your Top Digital Stars in 2024—Not Just Generate New Ones

Scaling seven common digital programs inside a typical top 10 pharma company could be worth $1.4 billion to $2.2 billion in operating income over five years.


Sharon Karlsberg

Latest:

Strategies to Close the Gap in Clinical Trial Recruitment

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


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