* CONTENT SUBJECT TO CHANGE

Focus: Clinical Trial Management

Essentials for Developing and Optimizing a Logical Sourcing Strategy
By Lee S. Scheible, Chris Bodurow, PhD, Karin Daun
While sponsor companies have expanded their level of outsourcing and embraced deeper and more integrated third party organization relationships, sponsors may not have the proper planning and oversight that can lead to operational efficiency, quality, and regulatory issues. This article discusses the essential steps for developing and implementing a logical sourcing strategy with third-party relationships in mind.

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
This peer-review article examines the history of eSource and EDC in clinical trials, the regulatory guidances now available and discussion on how eSource can be accomplished successfully.

Functional Outsourcing in the Pharmaceutical industry – a Project Management Perspective
By Yuri Martina PhD, MBA, PMP
This article discusses the keys of project management of clinical trials, from a project manager's first-hand experience.

The Current Status of RBM
By Linda Sullivan, BS, MBA, is Co-Founder & President of Metrics Champion Consortium
This peer-reviewed article is based on results of a survey conducted by the MCC and hones in on a select number of outcomes tied to key reasons for adopting RBM and CDA approaches.

Closing Thought
Patients Driving Diabetes Trials
By Matt Reaney , Medical Scientist, ERT
In its November 2014 approval of Trulicity for Type II diabetes, the EMA allowed Eli Lilly to summarize with one metric the patients’ appraisal of his or her experience with treatment in the clinical efficacy and safety section of the summary of product characteristics, representing the first of products to depend on PRO claims.