Blogs

As the risks grow of a disorderly UK withdrawal from the European Union, the warnings about what could go wrong for the supply of medicines in Europe become ever louder.

In the following Q&A, Guillaume Marquis-Gravel, MD, and Kevin Monroe discuss the advancements and related challenges of incorporating new technological tools in drug development, including eClinical approaches currently undertaken in the foundation’s own studies.

To further streamline product development and facilitate post market safety surveillance, the agency has developed a new Framework for Real-World Evidence that spells out opportunities and concerns in advancing these approaches.

In this article, Moe Alsumidaie will discuss QA updates.

European Union faces a critical view on its pediatric drug development situation, highlighting a lack of treatment, infrastructure, reimbursement, and regulatory agreement.

Supporting real change in clinical trials is more than just lip service-it’s putting the information out there transparently for all stakeholders to measure and make decisions.

IACT Health executive talks to Applied Clinical Trials about the importance of increased professional and technology investment at clinical trial sites.

In this interview, Carolyn Brehm, BMS Study Connect Business Lead, will discuss how BMS is helping to match patients with studies through Study Connect.

The decision of the leaders of the European Union over the weekend to endorse the Withdrawal Agreement for the UK's departure was historic in that it was the first time ever that the European Council had to face the imminent reality of a member state dropping out.

The core tenets of blockchain technology-a decentralized and encrypted way of distributing, sharing, and storing information-seem appealing for health data.

According to the IQVIA Institute for Human Data Science, the pharmaceutical industry loses roughly $35 billion annually as a result of temperature excursions, making transport one of the weakest links in many manufacturers’ supply chains.

Bracken Marketing has provided this infographic that categorizes more than 190 companies in this space by their focus.

In this interview, Katie Mazuk, Global Head Investigator & Patient Engagement, will discuss her perspectives on improving patient connectivity.

Peter Benton, President and Chief Operating Officer of Worldwide Clinical Trials (Worldwide), will discuss areas of opportunity, CRO differentiation strategies, and organizational diversity.

At PanAgora’s Clinical Trials Patient Experience Summit, three main topics stood out; companies engrained patient centricity guiding principles in their operational models, the new concept of patient connectivity is emerging, and digital health is rapidly gaining ground in clinical trials.

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.

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.

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.

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

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

Dr. Tshaka Cunningham, Associate Director of Scientific Collaboration for DIA, will discuss his perspectives on advancements in gene editing therapies and their impact on the industry.

As FDA continues to advance the role of patients in designing clinical trials with meaningful and accurate endpoints, it is seeking more input from stakeholders on how best to identify clinical outcomes most important to patients and caregivers.

Imagine you are in charge of European legislation on pharmaceuticals. Imagine you've been told to draft rules on how to conduct clinical assessments at European level to help measure the value of a medicine. What would you go for?

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.

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.

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.

The critical need for new medicines to combat infectious diseases is prompting FDA to join with other federal health agencies and the biomedical research community to advance the science, regulatory policies, and reimbursement strategies to promote innovation in this area.

Krista Armstrong explains the CRO's evolving role within clinical trials.