News

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.

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.

A new RBM method used in PaxVax trial proves successful vs. onsite source data verification for trial oversight.

In this interview, Michael J. Graziano, PhD, DABT, Vice-President, Drug Safety Evaluation for Bristol-Myers Squibb and leader of the BioCelerate Toxicology Data Sharing Initiative, provides more details about the DataCelerate platform.

This article will detail how the Amarex Safety & Pharmacovigilance team performs medical coding using an internally developed safety platform.

The mutual recognition agreement between the European Union and the US FDA now covers 15 European countries, after Portugal won US recognition in mid-September.

This article will summarize the discussion on innovation that took place at this years Cambridge Health Institute’s Clinical Trial Innovation Summit.