Authors


Ashley Simmons

Latest:

Improving Oncology Trials Through Adaptive Designs

How the practical application of these methods can help overcome the complex demands of cancer trials.


Austin Combest

Latest:

Improving Oncology Trials Through Adaptive Designs

How the practical application of these methods can help overcome the complex demands of cancer trials.


Jürgen Hummel

Latest:

Improving Oncology Trials Through Adaptive Designs

How the practical application of these methods can help overcome the complex demands of cancer trials.


Matthew Kibby

Latest:

Patient Recruitment Feasibility

Defining clinical trial feasibility and establishing a formula for patient recruitment success.


Gretchen Goller

Latest:

A Comprehensive Approach to Accelerating Clinical Trial Enrollment

It is well documented that lengthy start-up at individual trial sites related to contracting and committee reviews contributes significantly to delays.


Johanna Schenk, MD

Latest:

The PUEKS Project: Process Innovation in Clinical Trial Monitoring

A look at the results of the recently completed project, which aimed to develop an holistic monitoring system via process integration to more effectively control clinical trial risks beyond isolated RBM strategies.


Martin Lee

Latest:

A Comprehensive Approach to Accelerating Clinical Trial Enrollment

It is well documented that lengthy start-up at individual trial sites related to contracting and committee reviews contributes significantly to delays.


Peter Schiemann, PhD

Latest:

Discussion on TransCelerate’s QMS Initiative

TransCelerates work on their clinical trial Quality Management Systems (QMS) initiative began about one year ago. This article summarizes findings from a recent DIA publication about the initiative and evaluates potential issues during QMS framework implementation.


Beat Widler, PhD

Latest:

Endpoint Adjudication of Events Charter Template: What Should Be Included?

Endpoint adjudication is gaining importance in pharma today, however, no guidance on endpoint adjudication currently exists. The LinkedIn Endpoint Adjudication Community has generated an Events Charter Template to shed light on the subject for those in need of guidance.


Artem Andrianov, PhD

Latest:

BlockChain in Clinical Trials—the Ultimate Data Notary

Assessing the benefits of using blockchain technology as a notary service in the network sharing of clinical data.


Altair DaSilva

Latest:

A Comprehensive Approach to Accelerating Clinical Trial Enrollment

It is well documented that lengthy start-up at individual trial sites related to contracting and committee reviews contributes significantly to delays.


María Proupín-Pérez, PhD

Latest:

The PUEKS Project: Process Innovation in Clinical Trial Monitoring

A look at the results of the recently completed project, which aimed to develop an holistic monitoring system via process integration to more effectively control clinical trial risks beyond isolated RBM strategies.


Phil Birch, DPhil

Latest:

Why Smart Statistics Can Save Pharma

Fundamental weaknesses of modern clinical development can be resolved through recent statistical advances.


Malcolm Morrissey PhD

Latest:

Applying New Technology to Randomization, Cohort Management and Dosing in Multi-center Early Phase Trials

The drive to accelerate drug development has highlighted the benefit in using RTSM systems within early phase cohort trials.


Barry O’Gorman

Latest:

Applying New Technology to Randomization, Cohort Management and Dosing in Multi-center Early Phase Trials

The drive to accelerate drug development has highlighted the benefit in using RTSM systems within early phase cohort trials.


Darren Wells CGMA

Latest:

Applying New Technology to Randomization, Cohort Management and Dosing in Multi-center Early Phase Trials

The drive to accelerate drug development has highlighted the benefit in using RTSM systems within early phase cohort trials.


Richard Roberts B.Sc

Latest:

Applying New Technology to Randomization, Cohort Management and Dosing in Multi-center Early Phase Trials

The drive to accelerate drug development has highlighted the benefit in using RTSM systems within early phase cohort trials.




Tim Davis

Latest:

The Drive for Technical Innovation – Addressing Clinical Study Challenges

Technology now provides many advances that can determine the future of clinical trials. How sponsors, vendors, regulators and new entrants to the sector manage this transition will determine how effectively the industry adopts these tools.


Michael Federico

Latest:

Capturing Suicidal Patient Data

Meeting FDA requirements: the electronic collection of suicidal ideation and behavior data.


Mathini Ilancheran

Latest:

Is South Korea the Next Emerging Early Phase Destination?

The developed markets of North America and Europe together saw approximately 81% of the Phase I trial share in 2013 which is a 6% increase from 2012. Trials


Dr. J. Fred Pritchard, PhD

Latest:

Is South Korea the Next Emerging Early Phase Destination?

The developed markets of North America and Europe together saw approximately 81% of the Phase I trial share in 2013 which is a 6% increase from 2012. Trials


Sherilyn Adcock, PhD

Latest:

Satisfaction of Healthy Subjects in Phase I Trials

Survey applies rigorous analysis to provide a rare formal look at volunteer satisfaction in early setting.


John Sramek

Latest:

Satisfaction of Healthy Subjects in Phase I Trials

Survey applies rigorous analysis to provide a rare formal look at volunteer satisfaction in early setting.


Kurt Hauptmann

Latest:

Satisfaction of Healthy Subjects in Phase I Trials

Survey applies rigorous analysis to provide a rare formal look at volunteer satisfaction in early setting.


Hong Ding

Latest:

Satisfaction of Healthy Subjects in Phase I Trials

Survey applies rigorous analysis to provide a rare formal look at volunteer satisfaction in early setting.


Neal R. Cutler, MD

Latest:

Satisfaction of Healthy Subjects in Phase I Trials

Survey applies rigorous analysis to provide a rare formal look at volunteer satisfaction in early setting.


Keith Fern

Latest:

Community Clinics as Trial Sites—Bridging the Gap Between Health Care and Clinical Research

Turning community clinics into research sites requires provision of personnel, processes, technology, and infrastructure to conduct clinical research.


Pierre Geoffroy

Latest:

CNS Drug Liabilities in Early Phase Clinical Trials

Only eight percent of CNS drugs will reach approval, in part because of the high adverse effects standards.

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