News

In this article, Moe Alsumidaie will identify several bottlenecks that study sites experience from the subject recruitment to the enrollment phase.

Right at the start of the year, the calls for radical change in the way that drug development is organized are emerging thick and fast in Europe.

The FDA has been working to enable greater adoption of RWE in clinical and regulatory decisions, as mandated by the 21st Century Cures Act.

In this interview, Rashieda Gluck, Senior VP, Global Clinical Operations, at Aurinia Pharmaceuticals, will discuss how patient centricity techniques are benefiting smaller biopharmaceutical companies.

The instructions of a legendary 19th recipe for jugged hare began: "First catch your hare".

EMA drafted a plan for closer engagement with regulatory science in the next ten years, and it is looking for comments on its approach.

A discussion of the advancements and related challenges of incorporating new technological tools into drug development, including eClinical approaches currently undertaken in the foundation’s own studies.

From average merit increases from individual countries, to incentives per position, to retention bonuses and much more, a recent BDO report offers a robust look at an industry that has quickly eclipsed its “small company mentality” roots.

Right now, we only seek “perfect patients” for our trials, rendering many drugs potentially less safe or effective for those in demographics the study was not designed for.

Click the title above to open the Applied Clinical Trials January/February 2019 issue in an interactive PDF format.

FDA prioritizes to maintain, and continue to improve, the efficient and effective drug development and review system the agency has established in recent years.

An increase in use of EHR systems at clinical investigative sites adds more expectations for clinical trial sponsors to comply by regulatory requirements.

Case study demonstrates how one global mid-sized sponsor is testing the RBM waters.