Applied Clinical Trials-01-01-2019

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.

Using data analytics to introduce parallel processes to optimize and accelerate clinical trials.