Authors


Robert A. DiCicco, PharmD

Latest:

Accelerating Clinical Trial Design and Operations

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


Dan Gebow, PhD

Latest:

Transforming Clinical Event Adjudication in the Era of COVID-19

There's no one-size-fits-all approach during the COVID-19 pandemic


Gary A. Kaplan

Latest:

Where Do We Go From Here?

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


Avital Gaziel, PhD

Latest:

Rethinking ECOG Scores to Improve Patient Access and Clinical Trials Eligibility

Recent study results highlight need for new metrics in ECOG scoring to mitigate variability.



Gordon Kessler

Latest:

How a Global Privacy Standard Can Boost Patient Trust

Regulations that apply across geographic borders can provide researchers and patients a firmer foundation on data protection.


Kelly Corkey and Leonard Wee

Latest:

Pivoting Toward Sustainable Supply Chains in Clinical Research

As clinical research continues to globalize and grow at pace, there is a risk that global greenhouse gas emissions will escalate unless mitigation strategies are actively included in corporate strategies.


Allison Kalloo

Latest:

5 Ways DCTs Can Positively Impact Trial Diversity

COVID-19 forces life sciences industry to make long overdue changes.


Sowmyanarayan Srinivasan, Tanvi Vedhera, Garima Prashad, and Vishakha Sharma

Latest:

Leveraging Technology for Efficient Trial Design

Teams must work together with technology solutions and optimize integration to unlock their full potential.


Mariel Fabro

Latest:

Advancing COPD Research: Harnessing Wearable Sensors and Remote Monitoring for Improved Insights

Wearable sensors and remote monitoring technology can help HCPs monitor and manage COPD more effectively.


Yannis Jemiai

Latest:

Employing the Power of Bayesian Methods to Expedite Learning

Bayesian methods bring flexibility and speed to clinical trial design and analysis, and with increased access to the necessary computational power, are transforming today’s clinical research.



Simon Jones

Latest:

Clinical Trials Supply Chain: How to Respond to Recent Transformations

Concept of flexibility acting as driving force behind industry’s swift response to COVID-19.


Kenton Zavitz, PhD

Latest:

The Importance of Using Cognition as an Endpoint in Clinical Trials

How cognitive evaluations can aid in meeting the growing demand for more comprehensive safety profiles.


Archana Sah

Latest:

Optimizing Technology Implementation to Improve Diversity in Clinical Research

Three key considerations for deploying technology to help increase diversity in trials.


Andrew Hsu

Latest:

Towards Data-Driven Clinical Trial Planning and Strategy

Optimizing feasibility through increased data collection.


Kent Buhler

Latest:

How to Address—and Overcome—Operational Challenges in Master Protocol Studies

Trials that address multiple questions simultaneously using a master protocol can be operationally complicated. These complexities can be managed, even in studies used to support a marketing application.


Chris Crabtree

Latest:

What Patients Expect from Clinical Trials in the COVID-19 Era

Key takeaways from a survey of 250 oncology patients measuring COVID-19’s impact on patient willingness to participate in clinical trials.


Krystle Karoscik

Latest:

Immunomodulators and Cancer Research

Distinguishing CAR-T and CPI approaches and the clinical trial challenges and complexities associated with each.


Saama

Latest:

Three Ways to Leverage AI in Clinical Trials - Right Now

This eBook will discuss three key ways that researchers can implement AI to address data challenges, improve patient safety and outcomes, and accelerate processes.


Devin Ridgley, PhD

Latest:

Clinical Strategies to Optimize Software as a Medical Device to Treat Mental Health

With close collaboration between sponsors, CROs, and regulators, this emerging technology has the potential to greatly improve the lives of patients.


Maria I. Florez

Latest:

Improving Diversity in Clinical Trial Volunteer Participation by Addressing Racial and Ethnic Representation Among the Clinical Research Workforce

2020 Tufts CSDD study examines relationship between investigative site personnel diversity and study participant diversity.


Owen Corbin

Latest:

Confidentiality in DCT: How to Utilize Third-Party Home Health Providers

Alleviating sponsor and investigator concerns around sharing of remote-assessment data in accordance with GCP and GDPR standards.


Jonathan Jackson

Latest:

Importance of Diversity in Parkinson’s Research

Eliminating barriers to engage underrepresented populations.


C.K. Wang, MD

Latest:

Real-World Data Offers Significant Opportunities for Developing New Therapies for Hematologic Cancers

By integrating real-world data more deeply into the process of clinical research, life sciences stakeholders can open up new possibilities for therapeutic development and the evidence-based treatment of hematologic cancers.


Roger Sands

Latest:

WiFi Automation Keeps Decentralized Clinical Trials Running

Reliable internet connection an integral part of movement to DCTs.


Inger Ødum Nielsen, Vanessa de Langsdorff, and John April

Latest:

How Medical Writing and Regulatory Affairs Professionals Can Embrace and Deploy Generative AI at Scale

Unlocking the full potential of artificial intelligence requires these stakeholders to ensure their data are accessible and secure.


WCG Clinical

Latest:

WCG Randomized 1,600 Participants for RSV Vaccine Trial

A top 5 sponsor turned to WCG to recruit expecting mothers for its Phase III RSV vaccine trial. WCG support covered multiple countries and contributed almost one third of overall randomizations in the supported countries, bringing the study in ahead of schedule despite delays due to COVID-19 impacts on RSV seasonality. The sponsor met study timeline past enrollment by continuing to work with WCG’s retention support.


Jian Wang, PhD

Latest:

Integration of Point-of-Care Devices in Clinical Trials

A look at the future of clinical trial laboratory testing amid the emerging use of new devices at the point of care.


Christine Senn

Latest:

From Isolation to Integration: Improving Site-Sponsor Collaboration in Clinical Trial Startup

It takes a village to raise a trial, but most stakeholders are siloed on isolated islands.

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