Authors


Kerstin Forsberg

Latest:

Barriers and Solutions to Smart Clinical Program Designs

How the Clinical Development Design (CDD) Framework can offer repeatable, reusable clinical designs based on "enabling information."


Mary Banach

Latest:

A Roadmap for Implementing RBM and Quality Management

The importance of applying change management techniques throughout the preparation, planning, and execution of RBM and RBQM approaches.


IQVIA

Latest:

Innovative Clinical Outcome Assessment (COA) Solutions for Obesity Trials: Measuring Matters

Webinar Date/Time: Tuesday, May 6th, 2025 at 11am EDT|8am PDT|4pm BST|5pm CEST


Adam Ross Miller

Latest:

Machine Learning within the Clinical Trial Process

Machine learning technology is finding it’s way into today’s marketplace, specifically within business processes, by driving insurmountable value for corporations within the life science industry, writes Adam Ross Miller.


David Akirtava

Latest:

US Clinical Investigator Experience

This data analysis takes a look at how much experience US clinical investigators have.


Cynthia Pritchard, PhD

Latest:

Three Steps to A Successful Combination Product Trial

Sponsors can streamline the design and execution of their clinical trials by following this three-step approach.


Darshan Kulkarni, PharmD

Latest:

How Does Shinal v. Toms Affect Informed Consent in Pennsylvania Clinical Trials?

The ruling by the Pennsylvania Supreme Court requiring informed consent to be obtained by a medical doctor could set a precedent for future nationwide cases involving clinical research.


Andrea Tunnard

Latest:

How Does Shinal v. Toms Affect Informed Consent in Pennsylvania Clinical Trials?

The ruling by the Pennsylvania Supreme Court requiring informed consent to be obtained by a medical doctor could set a precedent for future nationwide cases involving clinical research.


Erin Grant

Latest:

How Does Shinal v. Toms Affect Informed Consent in Pennsylvania Clinical Trials?

The ruling by the Pennsylvania Supreme Court requiring informed consent to be obtained by a medical doctor could set a precedent for future nationwide cases involving clinical research.


Ülker Aydemir

Latest:

Estimands and Implications for Sponsors as ICH E9 (R1) Addendum Progresses

Sponsors should be aware of the significant implications the Addendum is likely to have on clinical trial planning, conduct, statistical analysis, and interpretation.


Sandy Chase

Latest:

Why We Should Talk to Patients Who Drop Out of Clinical Trials

Sandy Chase focuses on the voice of the patient and their experience after not completing a clinical trial.


Darryl G. Glover

Latest:

Improving the Traceability of the Clinical Trial Supply Chain

Outlining the benefits of using blockchain technology across the supply chain to more securely record and distribute data to sites.


Jan Hermans

Latest:

Improving the Traceability of the Clinical Trial Supply Chain

Outlining the benefits of using blockchain technology across the supply chain to more securely record and distribute data to sites.


Erin Muhlbradt

Latest:

CDISC Glossary of Clinical Research Terminology

Reference tool is a Rosetta Stone for clinical research. A look at the updates and enhancements in latest version.


Art Gertel

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.



Steve Raymond

Latest:

CDISC Glossary of Clinical Research Terminology

Reference tool is a Rosetta Stone for clinical research. A look at the updates and enhancements in latest version.


Antonina Smolina

Latest:

Positive Changes for Clinical Trials in Ukraine

The Ukrainian Government has implemented several important measures to make the country more attractive for clinical trials.


Volodymyr Svintsitskyi

Latest:

Positive Changes for Clinical Trials in Ukraine

The Ukrainian Government has implemented several important measures to make the country more attractive for clinical trials.


Darcee Duke Strube

Latest:

Dermatology Biologics: Overcoming Challenges to Fulfill Therapeutic Potential

To vie for success in the market for dermatologic therapies, companies developing biologics must navigate a series of significant challenges, including patient compliance and safety.


Tim Hoctor

Latest:

Solving the Data Riddle to Yield Hope for Orphan Disease

This article will explore the issues of a lack of data standards; focusing on an industry hackathon that analyzed data sets relating to rare diseases.


John Ryals, PhD

Latest:

Metabolomics: Improving the Route from Early Drug Discovery through Clinical Development

Metabolomics can make a positive impact from early drug discovery through clinical development and beyond.


Dominique Muszinski

Latest:

Sponsors Ask: Is Our Trial Plan Realistic? Toward a Data-Driven Feasibility Assessment

Today, a data-driven approach to feasibility assessment can help ensure that a sponsor’s clinical research plan is designed to enroll the right patients, rely on the right investigators, and take place in the right countries for success.


Otis Johnson, PhD

Latest:

Optimizing Technology Implementation to Improve Diversity in Clinical Research

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




Amy Del Medico

Latest:

Mitigating Risk in Implementing Multi-Regional Trials in MS

Examining the main challenges in designing and executing MS clinical trials and proposing mitigation strategies that may help alleviate these burdens.


Marie Trad, MD

Latest:

Mitigating Risk in Implementing Multi-Regional Trials in MS

Examining the main challenges in designing and executing MS clinical trials and proposing mitigation strategies that may help alleviate these burdens.


Sam Khinda

Latest:

Mitigating Risk in Implementing Multi-Regional Trials in MS

Examining the main challenges in designing and executing MS clinical trials and proposing mitigation strategies that may help alleviate these burdens.


Benjamin Moody, PhD

Latest:

Mitigating Risk in Implementing Multi-Regional Trials in MS

Examining the main challenges in designing and executing MS clinical trials and proposing mitigation strategies that may help alleviate these burdens.

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