Peer-Reviewed Articles

Risk-Based Monitoring Case Study: Lessons from a 3,389-subject Global Phase III Trial

By Lisa James

A snapshot of one novel approach in RBM implementation and the data and site performance lessons learned.

Clinical Trial Data Stewardship

By Tom Haag, Tom Koch

Amid the push for clinical trials to adopt more modern digital data technologies, the job of assuring adherence to key data quality and integrity principles is achievable under current regulations. Doing so, however, will require a new and reinvented framework: data stewardship.

Challenges of Clinical Site Management in Eastern Europe and Cross-Regional Prospective

By Nikolay Grechko, MD, Kateryna Bezditko, PharmD, PhD, Sergii Myronenko, MD

Survey of pharma and CRO clinical trial professionals attempts to answer whether Eastern European countries are still considered attractive destinations for clinical research.

Barriers to Clinical Trial Recruitment and Possible Solutions: A Stakeholder Survey

By Elizabeth Mahon, Jamie Roberts, Pat Furlong, Gina Uhlenbrauck, Jonca Bull, MD

A staggering number of clinical trials fail to meet recruitment goals, which leads to delays, early trial termination, or inability to draw conclusions at trial completion due to loss of statistical power.


Expanding Data Management Services in China: Additional Insights Into a Rapidly Growing Market

By Simon Hawken

Even with the rapid increase in clinical trials and demand for cloud-based systems, doing business in China is not easy if you are unfamiliar with the territory.

Will Hillary’s Prescription Drug Plan Hinder R&D?

By Moe Alsumidaie

Democratic candidate Hillary Clinton is introducing her Prescription Drug Plan which is meant to benefit patients, however, will Hillary’s plan be good for advancing novel therapies, and will it benefit R&D organizations?

Centralized Monitoring--A Smart, Reliable Approach

By Ashok Ghone

The successful implementation of centralized monitoring requires effective planning, process restructuring, cross-functional expertise alignment, and the right technology in place.


Mergers & Acquisitions and Strategic Alliances in Life Sciences

October 14 - 15, 2015
The Ritz-Carlton, Philadelphia, PA

Prep Forum for the New EU Clinical Trials Regulation

October 19 - 20, 2015
Wyndham Historic District , Philadelphia, PA

NORD 2015: Rare Diseases and Orphan Products Breakthrough Summit

October 21 - 22, 2015
Crystal Gateway Marriott, Arlington, VA, USA

Data Analysis

Only 35% of Sponsors Have Met Their Outsourcing Match

We all need help sometimes. For pharmaceutical companies, this often comes in the form of a reliable and competent contract research organization.

Enrolled Patient Numbers

Randomized Clinical Trials (RCTs) have constituted the foundation for new drug approvals for over fifty years.

Inclusion/Exclusion Criteria Show Minimal Rise

Few topics occasion the lamentations of clinical trial professionals more than the topic of patient inclusion/exclusion criteria in clinical protocols.


Mobile, the Future of Patient Reported Outcomes

By Chris Watson

Mobile strategies bring near-endless possibilities to engage with patients in clinical trials.

TransCelerate’s QMS Initiative: Interview with Merck’s Deborah Driscoll

By Moe Alsumidaie

TransCelerate's Quality Management System (QMS) Initiative delineates specific mechanics that will be used to build a QMS Conceptual Framework to facilitate and encourage proactive approaches towards executing Good Clinical Practices, and proper change management expected to support a culture of quality.

Mobile Medical Apps as Investigational Devices

By Elizabeth Brooks, Prithul Bom

Considerations for Using a Mobile Medical App as an Investigational Device



Metrics and Analytics: How to Evaluate Clinical Operations

As the push to contain clinical trial costs and make informed business decisions continues, more pharma and CROs are looking at internal and external benchmarking and metrics to evaluate their performance—both successes and challenges. This e-Book includes articles that show how analytics uncover problem areas in clinical operations, as well as metrics and databases that are used to pinpoint internal or external performance issues.



Risk-Based Monitoring in Clinical Trials 

This latest, updated eBook on Risk-Based Monitoring from Applied Clinical Trials includes the latest information on the topic being discussed around clinical trials. Includes pitfalls to avoid when implementing an RBM strategy, and an update on Cancer Research UK's implementation.



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.