Peer-Reviewed Articles

Quality Drivers In Clinical Trial Conduct

By Michael J Howley PA-C, PhD, Peter Malamis, MBA

Adopting scientific quality measurement that recognizes that clinical trials are a service will reap benefits.

Quality Metrics for Clinical Trials

By Jonathan Rowe, Denise Calaprice-Whitty

A case study by Pfizer & The Avoca Group on the development of an overarching strategy for Pfizer’s clinical trial quality metrics.

Is There a Link Between Recruitment and Social Media?

By Yves Geysels, Vincent Schroyens, Jessica Van Den Broeck

A survey of Belgian clinical research professionals offers insights into the future of social media.

Managing Portfolios to Deliver Economic and Clinical Value

By Rita E. Numerof, PhD, Michael J. Kuchenreuther, PhD, Jill E. Sackman, DVM, PhD

The importance of focusing on both outcomes as early as possible in the product development cycle.

Blogs

FDA Seeks Smooth PDUFA Renewal Process

By Jill Wechsler

The schedule is particularly tight this time because the user fee reauthorization process coincides directly with the presidential elections.

FDA Wants to Know: How Social Media Can be Used to Uncover Adverse Events

By Lisa Henderson

It appears the role of social media in post-market adverse event reporting is being taken seriously by the FDA.

Targeting eTMF for Efficiency and Productivity Gains

By Lori McKellar

In clinical trials, the ability to effectively plan, collect and maintain essential clinical trial documentation is challenging.

Data Analysis

CRO Quality Benchmarking

It is well known within the industry that being on a sponsor’s preferred provider list affords a critical leg up to providers hoping to win business.

Challenges to Implementing mHealth

A recent survey conducted by Applied Clinical Trials and SCORR Marketing on mHealth in Clinical Trials.

Latin American Investigators

As part of a global 4,000 site mail and on-line survey, we examined the reasons behind Latin American clinical investigators decision to take part in clinical research.

Noteworthy

Considerations for Clinical Trial Design in Public Health Emergencies

By Jeffry Liu

While the fundamental concerns behind the design of most modern clinical trials are effectively the same, clinical trials that take place during public health emergencies face additional layers of challenges.

The Top Ten Tweets of 2015 (So Far)

By Miraj Barodia

This list compiles some of our more popular articles on Twitter, click through and find out what made the cut.

Three Categories Influencing Clinical Trial Data Quality

By Moe Alsumidaie, Beat Widler, PhD, Peter Schiemann, PhD

The aforementioned article emphasized that a reduction in data quality ultimately leads to enrolling more clinical trial subjects in order to maintain equivalent statistical power.

eBooks

 

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.

 

 

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. 

 

Events

NORD 2015: Rare Diseases and Orphan Products Breakthrough Summit

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

Risk-Based Trial Management

November 05 - 06, 2015
Hilton Philadelphia City Avenue, Philadelphia, PA, USA