
A high-level working group of European regulators is trying to pull together a more coherent approach to real-world evidence-and is running into difficulties with the wide range of initiatives currently underway.

A high-level working group of European regulators is trying to pull together a more coherent approach to real-world evidence-and is running into difficulties with the wide range of initiatives currently underway.

Although it is unlikely that mock demonstrators will be seen at any drug information or regulatory conferences, pharmacovigilance software is indeed having its “Salesforce” moment.

In this interview, Lisa Dilworth, as VP, Rare and Orphan Diseases at Synteract, will discuss common challenges with rare disease studies, how to encounter them, and how the rare disease space is evolving.





To inform our understanding of public and patient trust and confidence, this article provides a high-level summary of the results of two studies monitoring trends in international public and patient attitudes and perceptions.

FDA initiatives aim to increase biomarkers and early advice to sponsors for more efficient and cost-effective clinical trials for developing targeted therapies, including orphan therapies.

Pharma and diagnostics companies need to strengthen alignment in Alzheimer’s disease research-to help turn science and data into actionable medical innovations.

Pilot study compares a risk-based monitoring and remote trial management method with traditional on-site source data verification for trial oversight.

All of Europe, from MEPs to WHO, aims to develop a comprehensive health policy, with a current priority on nutrition and physical activity.

Blockchain is moving toward definitive uses in clinical trials to enhance clinical supply capabilities, with the potential of enabling data ownership for patients.

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



October has offered a striking spectacle of contrasts in Europe's ponderous attempts to construct a comprehensive policy on health.



This article delves into the why, when, and how a patient-centric approach should be adopted for both the benefit of patients and the successful development of novel and innovative medicines.









