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


How Do We Define Clinical Trial Data Quality if No Guidelines Exist?

By Moe Alsumidaie, Artem Andrianov, PhD

Many of us speak about the importance of clinical trial data quality and integrity, yet the lack of data quality standards and definitions introduces subjectivity risk in clinical trials.

The Patient’s Voice is Finally Being Heard in Diabetes Drug Research

By Matthew Reaney

Type 2 diabetes mellitus is one of the Western world’s most common chronic conditions, with global prevalence increasing rapidly.

Califf Seeks New “Ecosystem” for Clinical Trials

By Jill Wechsler

Current clinical trials are regarded as “too slow, too expensive, not reliable, and not designed to answer the important questions,” according to FDA’s new deputy commissioner for medical products &tobacco, Robert Califf.

Data Analysis

Number of Clinical Trials 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.

Adaptive Trial Designs Gaining Momentum

Faster go/no-go decisions is the primary driver of adaptive-design adoption by sponsors.


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



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.