Authors



Andrey Tarakanov, MD

Latest:

Clinical Trials in Kazakhstan: Open For Business

This brief overview of Kazakhstan presented by Vlad Bogin will help you get acquainted with this emerging clinical trial location.


Nina Baluja, M.D.

Latest:

Cancer Immunotherapy Biomarkers: Four Trends to Watch

Here are four trends to watch as researchers continue to make headway in the development of biomarkers for cancer immunotherapy.


Roopal Patel

Latest:

Overcoming Complexities of Clinical Trial Supplies in Latin America

Supply chain strategies require a close look at the regulatory factors and the drug import hurdles and hopes in the region.


Juan Bamberger

Latest:

Overcoming Complexities of Clinical Trial Supplies in Latin America

Supply chain strategies require a close look at the regulatory factors and the drug import hurdles and hopes in the region.


Richard Segiel

Latest:

Monitoring Temperature Control Throughout IMP Supply Journey

How a single-source temperature management strategy can support a drug’s quality and integrity in transit-a process as important as the destination.



Thomas Ogorka

Latest:

The Impetus for Natural History Studies in Rare Disease R&D

The use of natural history (NH) studies early in clinical research can help facilitate development programs for orphan drugs.


Gajendra Chanchu

Latest:

The Impetus for Natural History Studies in Rare Disease R&D

The use of natural history (NH) studies early in clinical research can help facilitate development programs for orphan drugs.


Robert Dannfeld

Latest:

New Role To Improve Clinical Trial Performance

With several systems existing to measure performance, the most significant are the course of patient recruitment, how many patients complete the study, as well as the quality of the data generated.


Lisa Bance

Latest:

Four Pillars to Achieve Patient Centricity

ZS Associates specify the four pillars of patient centricity that can help the demands and complexities of clinical trials.


Venkat Sethuraman, PhD

Latest:

How Pharma Can Work with the FDA to Embrace Innovation and Overcome Its “Adoptaphobia”

FDA commissioner Scott Gottlieb criticized pharmaceutical companies and clinical research organizations for being slow to adapt innovations in clinical research, claiming that the business model adopted just isn’t compatible with the kind of changes that certain innovations can enable.


Kristyn Feldman, PhD

Latest:

Four Pillars to Achieve Patient Centricity

ZS Associates specify the four pillars of patient centricity that can help the demands and complexities of clinical trials.


Aaron Mitchell

Latest:

Four Pillars to Achieve Patient Centricity

ZS Associates specify the four pillars of patient centricity that can help the demands and complexities of clinical trials.


Christine Künzl, PhD

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.


Burkhard Breuer, PhD

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.


Yvonne Rollinger, PhD

Latest:

Can Data from EHR Systems Be Trusted in a Trial Setting?

An increase in use of EHR systems at clinical investigative sites adds more expectations for clinical trial sponsors to comply by regulatory requirements.


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."

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