Noteworthy

A Structured Approach to Implementing a Risk-based Monitoring Model for Trial Conduct

By T. Hinkley, E. Stevens, M. Blanchford, C. Eberhart, M. Furay Fay

An effective risk mitigation model requires the development of a structured approach to risk identification, analysis and control, from trial inception to completion.

Transforming Cognitive Health Conditions through Clinical Games

By Mathini Ilancheran, Akhila Satish

As clinical games emerge as a new tool for diagnosing and treating cognitive health, it is important to understand how these tools work and the ways in which these tools are validated, as well as how to realize their full potential.

Risking It All? Introducing Risk-Based Monitoring at Cancer Research UK

By Sherraine Hurd

The Cancer Research UK recently decided to have its Center for Drug Development adopt a risk-based monitoring approach across its entire portfolio of clinical trials.

Blogs

Compassionate Use Debate Heats Up

By Jill Wechsler

Patient access to critical experimental medicines continues to grab public attention, as states enact “Right-to-Try” laws and Congress eyes establishing a national policy to provide not-yet-approved therapies to terminally ill patients.

Biosimilar Development Moves Forward at FDA

By Jill Wechsler

FDA has scheduled a public meeting in early January to assess and weigh the data on the first US application for a biosimilar therapy.

Europe Says Goodbye to Another Type of Transparency

By Peter O'Donnell

After nearly five years of argument, the European Union's proposal to update its transparency directive for medicines has been dropped.

Data Analysis

Time for Another CRF Migration

Medidata took a look at how eCRF design complexity correlates with the number of migrations performed while a study is actively collecting subject data.

The Cost to Develop an Approved New Drug Now Exceeds $2.5B

Tufts CSDD estimates that the cost to develop a new prescription medicine that gains marketing approval is now $2.6 billion.

Events

Clinical Data Disclosure and Transparency

February 24, 2004 - February 24, 2016
Doubletree by Hilton Center City, Philadelphia, PA, USA

Clinical Enterprise Architecture and Data Governance

February 26, 2014 - February 26, 2016
TBD, Philadelphia, PA, USA

Clinical Data Disclosure and Transparency

January 28 - 29, 2015
Doubletree by Hilton Philadelphia Center City, Philadelphia, PA, USA