Authors



Kate McGowan

Latest:

Observations from AACR 2014

This year the AACR conference was focused on "Harnessing Breakthroughs, Targeting Cures."


Kathleen W. Wyrwich

Latest:

Personalized Healthcare

What works when and for whom in the era of comparative effectiveness research.


Charlie Morris

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Sustaining Innovation

Constant technological advancements continue to alter the compliance battle.


Selina Sibbald

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Risk-Based Approaches

The eClinical Forum Risk Based Monitoring Taskforce offers some best practices for ensuring clinical data quality.


Ashley Mehta

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Objective Internal Monitoring

Sponsors are responsible for monitoring studies, patient safety, and data integrity.



eyeforpharma

Latest:

State of the industry: Data & Technology in Clinical Trials

Teaming up with Eli Lilly and DrugDev Advisory Board, eyeforpharma conducted a 'State of the Industry' survey to investigate how pharma is currently leveraging data and technology and how this will change over the next 2 years. Highlights include: - Adopt a risk based approach for a cheaper way to clean your data, ensure optimum data quality and patient safety - Integrate real world and real time data for faster data generation, to quickly demonstrate value to patients and find urgent answers to unmet needs - Overcome rising R&D costs by utilizing big data to identify patient sub groups, integrate patients into research stages to better identify new biomarkers and provide more personalized treatments - See how mobile and wearable devices encourage patient participation by virtualizing parts of trials, reduce patient burden and enhance data quality


Paul O'Donohoe

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Treating Alzheimer's Early

The FDA has released its plan for pre-dementia Alzheimer's trials.


Michelle Foust

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Strengthening the Links in the Clinical Supply Chain: Aim for Transparency throughout the Process

Most business leaders acknowledge the pitfalls of organizational silos: they breed inefficiency and signal systemic malfunctioning.


Donelle Bussom RN, MSN

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Implementation and Usage of Data Monitoring Committees

Exploring sourcing model options for appropriate incorporation of DMCs into a clinical program.


Jesse M.Glass

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Are Phase III Clinical Trials Really Consistently Behind Schedule?

With a unique business model, pharmaceutical companies and their subcontractors need to find every way possible to shorten drug development times consistent with patient safety. The challenges facing commercially oriented organizations developing prescription drugs are substantial.


Chris Hamilton

Latest:

Achieve Sustained Clinical Trials Quality in a Functional Service Provision

Functional service provisions can provide sponsors and CROs with a way to efficiently manage clinical trial outsourcing methods.


Felix Frueh

Latest:

Personalized Healthcare

What works when and for whom in the era of comparative effectiveness research.


Amy P. Abernethy

Latest:

Personalized Healthcare

What works when and for whom in the era of comparative effectiveness research.


Piergiorgio Galletti

Latest:

How to Improve Clinical Research in Children: A Survey on the Perception of European Pediatricians and Industry/CROs

The Pediatric Working Group of the European CRO Federation conducted a follow-up survey on the status of pediatric clinical trials in Europe.


Igor Astsaturov

Latest:

The Shifting Paradigm in Clinical Trial Design for Anti-cancer Drugs

How molecular profiling is impacting today's cancer medicine.


Debbie McCann

Latest:

Risk-Based Approaches

The eClinical Forum Risk Based Monitoring Taskforce offers some best practices for ensuring clinical data quality.


Context Matters

Latest:

Patient-Reported Outcomes in Oncology: If No One Pays Attention to Data, Does it Really Exist?

In a recent piece published in the New England Journal of Medicine, oncologist Dr. Ethan Basch talks about his perspective that patient-reported outcomes (PROs) are not widely used in the development process for cancer drugs because they are not often measured in clinical trials.


Linda Strause

Latest:

Patient-First Approach to Improve Oncology Clinical Trials

Life can change in an instant, but there is one thing that always abides: hope.


Patrick Nadolny

Latest:

Risk-Based Approaches

The eClinical Forum Risk Based Monitoring Taskforce offers some best practices for ensuring clinical data quality.


Adam Sherlock

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Outsourcing: China Takes Center Stage

Conversion from paper to ePRO for an instrument designed to assess diabetes' impact on quality of life.



Rajendra Talele

Latest:

Warning Letter Study

An analysis of warning letters and the findings reported from 1996 to 2010.



Bruno Speder

Latest:

Regulatory Considerations Surrounding Human Challenge Studies with the SARS-CoV-2 Virus

A first vaccine against this coronavirus could still take some time to develop, but mRNA vaccine platforms could offer an early breakthrough.


Benoit Cloquet

Latest:

Optimizing Trial Supplies Via Integrated e-Platforms

eGSP-driven approach focuses on overcoming operational challenges through data integration.


Dean A. Gittleman

Latest:

eSource Records in Clinical Research: Keeping it Simple

How to satisfy regulatory concerns about EDC data integrity and site controls over its source records.


Christophe Golenvaux

Latest:

Optimizing Trial Supplies Via Integrated e-Platforms

eGSP-driven approach focuses on overcoming operational challenges through data integration.


Phillip B. Chappell

Latest:

Risk Assessment and Mitigation

A quantitative approach to enhancing risk assessment and mitigation in drug development.

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