Peer-Reviewed Articles

eSource Records in Clinical Research: Keeping it Simple

By Jules T. Mitchel, Jonathan Helfgott, Tom Haag, Silvana Cappi, Imogene McCanless, Yong Joong Kim, Joonhyuk Choi, Timothy Cho, Dean A. Gittleman

There has been a recent thrust within the pharmaceutical industry to promote the transformation of the clinical trial process.

Determining Participation in Ukraine

By Nataliia Vietchinkina

Survey shows what keeps Ukrainians away from clinical trials.

Designing Quality Improvement Registries

By Michelle Leavy, Daniel M. Campion

Focusing on efficiency and sustainability from the start improves the likelihood of success.

The Current Status of Risk-Based Monitoring

By Linda B. Sullivan

A comprehensive survey by Metrics Champion Consortium

Blogs

Project Managers Committee Will Shape Content and Direction for Colleagues

By Lisa Henderson

Recently, Applied Clinical Trials formed a Project Manager Committee, whose members will advise us on matters important for them to succeed in their positions

The Patients 2 Trials Consortium: Breaking News

By Michael Christel

Engaging and recruiting participants for clinical trials continues to be a struggle for the life sciences industry.

New Approaches to Speeding Up Clinical Trials – What Works and What Doesn’t

By Michael Christel

The concept of increasing the speed and efficiency of clinical trials is a well understood and agreed upon priority of most clinical operations professionals.

Data Analysis

FDA Audits May Not Indicate Protocol Complexity

An increasing amount of public data on clinical trial research has become available, including ClinicalTrials.gov and Open Payments.

Number of Clinical Trials

ClinicalTrials.gov is a federally mandated database with a large and growing, number of required data fields. Organizations are required to report any study being conducted under FDA auspices.

Examining the Stats: The “One Time” Investigator

Do 50% of US investigators only conduct one clinical trial? Much of the misunderstanding behind this “one time” claim, which first surfaced in the 1990s, rests on a misunderstanding of the BMIS.

Noteworthy

Business and People: May 2015

By Miraj Barodia

New faces among the Pharma Industry rise the ranks.

The Health of the Clinical Trials Industry

By Applied Clinical Trials Editorial Staff

Graphics and data regarding the current state of the Clinical Trials industry.

Fifth Industry-Wide Trial Master File Reference Model Survey is Now Open

By Applied Clinical Trials Editorial Staff

Make sure your perspective is heard, and get valuable insights and data for your TMF improvement initiatives

eBooks

 

Clinical Trials Project Management 

Every trial starts with a budget, and a clinical trial study start-up process that can be fraught with delays. From contract negotiations, to managing a trial for a sponsor, to streamlining study start-up process, this eBook seeks to instruct others on best practices.

 

Real World Evidence in a Clinical Trials World

With a growing need for post-marketing safety databases, and increased need to collect qualitative information from patients in the pre- and post-market of a drug the evidence gathering from clinical trials onward is expanding. 


 

Risk-Based Monitoring in Clinical Trials

As acceptance for risk-based monitoring grows, this e-Book examines next steps for sponsors and CROs. This e-Book offers case studies, practical tips, and applications to enhance the effectiveness of a risk-based monitoring strategy.


 

 

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