Authors


Michael Sigmund

Latest:

Consequences of Brexit for Clinical Trials in Europe

Higher costs headline list of new challenges faced by CROs and sponsors.


Veronika Kunert

Latest:

RBM—An Update of Experiences Among European CRAs

An RBM survey conducted in 2014 was repeated in 2016 in order to find out, how knowledge and practical experience with RBM have changed over that time period.


Thomas Moehler, MD

Latest:

Cancer Trials: Raising Accrual Rates

Lessons learned from the recruitment of colorectal cander patients into clinical trials.


Ashok Ghone, PhD

Latest:

The Risk Based Monitoring Plan

Sponsors and CROs are looking into implementation of a Risk Based Monitoring approach to their clinical trials to achieve the objectives related to enhanced data quality, better monitoring of patient safety, and creating efficiencies in overall operations.



Josef von Rickenbach

Latest:

Strategic Partnerships Evolve

Greater product value and innovation accomplished with sponsor-service relationships.


Steve Young

Latest:

Achieving Optimal Adoption of Risk-Based Quality Management

The need to boost education, shift culture, and embrace new technologies.


Ellen Coleman

Latest:

Through the Patient Perspective: Collaborating to Improve Research and Development

At the October Metrics in Patient Centered Drug Development conference hosted by DIA, many of these key constituents gathered to talk about how to implement and measure the impact of patient input.


Hon-Sum Ko

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."


Ian Fisher

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."


Rashedul Hasan

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."


Laszlo Vasko

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."


Courtland E. Yockey

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."


Mitra Rocca

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."


Maria Benjegård

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."


Johann Proeve

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.


Dale Plummer

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."


Steven Hirschfeld

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."


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:

Impact of FDA Project FrontRunner on Oncology Drug Development

Webinar Date/Time: Tuesday, December 10th, 2024 at 11am EST | 8am PST | 4pm GMT | 5pm CET


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.

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