Applied Clinical Trials-10-01-2018

In this article, Crissy MacDonald reviews the key changes in ICH E6 (R2), discuss the challenges organizations are facing, and present actionable recommendations for organizations to implement now.

A new report on EU's digital health strategy also calls for closer coordination of national HTA arrangements-but both policy initiatives couldn't be more different.

FDA is joining with other federal health agencies and the biomedical community to advance science, regulatory policies, and reimbursement strategies to combat the need for new medicines for infectious diseases.

Success in developing targeted medicines means companies need a companion diagnostic strategy, the expertise, and more.

Forming strategic alliances and collaborating to optimize study design can significantly improve pediatric drug development.

How mapping patients’ health journeys can drive a deeper understanding of their experiences and motivations.

Q&A highlights one such example of M&A movement in the CRO space toward mid-sized companies focused in specific disease indications.

A multitude of data sources leaves clinical data management systems in catch-up mode-and researcher dizzy trying to follow the data- but there is hope for simplification on the horizon.

Key tips and resources to help evade the common traps of market landscaping-today an increasingly high-stakes and comprehensive task during clinical development.

Click the title above to open the Applied Clinical Trials October 2018 issue in an interactive PDF format.