Authors


Oleksii Korzh, MD, PhD

Latest:

Clinical Trials in Ukraine During the War

Industry must take steps in preserving data for use after the war.


Charles T. Lancaster

Latest:

De-Risking Trials with Science-Driven Oversight

Identifying the ‘significant six’ areas of clinical study conduct to mitigate risk.


Andreas Dreps

Latest:

Overcoming Challenges in the Development of Antibody Drug Conjugates

For antibody drug conjugates to reach their full potential, developers should focus on addressing current challenges such as safety and efficacy.


Kristin Tolbert

Latest:

Pregnant Women: An Underrepresented Group in Clinical Trials

Recent research is showing medical treatment for pregnant women often relies on clinical data from non-pregnant female patient populations.


Cindy Henderson

Latest:

Accelerating Clinical Trial Design and Operations

Fully-integrated, component-based CDMS offers flexibility, customization, and efficiency.


Clint D. Hermes

Latest:

COVID Challenges for Trials in Low-to-Middle-Income Countries

Outlining the five critical hurdles faced by clinical teams conducting studies in these nations amid quarantine and other restrictions.


John R. Nocero, PhD

Latest:

10 Questions to Consider With eTMF Vendor Selection

The many different shapes and sizes of vendors requires a thoughtful process for selection.


Igor Kruglyak

Latest:

How NLP, OCR, and Social Graphs Accelerate Subject Recruitment for Clinical Trials

Explore how natural language processing and social graph techniques help to tackle the challenge of patient and investigator recruitment and raise the success rate of clinical trials.


Patrice Hugo, PhD

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.


Emily Botto

Latest:

Assessing Sponsor Attitudes Toward Retail Pharmacy Involvement in Clinical Trial Recruitment and Execution

Amid CVS’ surprise exit from the clinical research space and the ensuing broader questions, study investigates the benefits of pharmacy chain involvement—along with the concerns and barriers to adoption.


Kaj Stenlöf MD, PhD

Latest:

Using Real-World Data in Patient Recruitment

Growing availability of RWD leads new drug development process.


Evidation

Latest:

How person-centered trial design improves clinical research

Learn how to develop and market products and interventions that actually meet individuals' needs by incorporating patient input exist throughout the trial lifecycle



Melanie Nelson

Latest:

Solutions to Accelerate Data-Driven Chemicals and Materials Innovation

Teams need to keep close track of ingredients, processing parameters, and material performance so that they can use their R&D data to decide exactly which materials to make next.


Paul Ingram, PhD

Latest:

Evaluating Global Regulatory Landscape for Driving Digital Innovation in Supply Management

Recent updates from regulatory bodies are providing more confidence in integrating different forms of trials and technology.


Elaine Lim

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.



Jill Guary

Latest:

Executing Trial Design With Patients—Not For Patients

Approaching protocol design and operational planning with patient empathy.


Helen Hemley

Latest:

Importance of Diversity in Parkinson’s Research

Eliminating barriers to engage underrepresented populations.


Justin Hay, 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.


Michael Stadler

Latest:

What the Future of Study Review Processes Should Look Like

Insights from Bayer’s study review process showcases importance of incorporating feedback from a wider audience of stakeholders.


Ellyn Getz, Rodney Winley, VeQuain Joyner, and Dezbee McDaniel

Latest:

Generational Differences Among African Americans, Their Experiences with the Healthcare System

A study exploring healthcare preference and experience in this population group uncovers new insights and opportunities related to clinical research participation.


Douglas Peddicord, PhD

Latest:

CROs Rise to COVID Pandemic Challenges

Industry must take advantage of "lessons learned."



Pierre Chetelat

Latest:

Sharing Anonymized and Functionally Effective (SAFE) Data Standard for Safely Sharing Rich Clinical Trial Data

Presenting how data transformation is measured as part of the SAFE Data Standard, which data variables influence the rating and, how the appropriate level of data transformation is calculated.


Mike Hennessey Sr.

Latest:

Clinical Trials Diversity and Inclusion

Chairman and Founder of MJH Life Sciences, Mike Hennessy Sr. explores the main discussion points covered in the June issue of ACT.


Megan Trost

Latest:

Addressing the Needs of Clinical Trial Sites in a Post-COVID-19 World

Recognizing pre-pandemic pain points, such as patient engagement and protocol development, could lead to post-pandemic trial success.


Dr. Mwango Kashoki, MD, MPH

Latest:

Effective regulatory strategies for rare disease

In the rare disease issue of New Medicines, Novel Insights from Parexel, experts and former regulators share insights for developing effective regulatory strategies earlier.


Enno Behrendt

Latest:

Targeting Patient Population

Keys to ensuring your clinical trials better reflect your target population.


Adelina Paunescu, PhD

Latest:

Budgets and Billing in Clinical Trials: DCT Considerations

Cost strategies for medical device trials in the new era of digital health.

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