Demand-led Supply: Increasing Efficiency in Clinical Studies Logistics
Cost pressures associated with the development of new medications are at an all-time high for the pharmaceutical industry. Drug development…
Cost pressures associated with the development of new medications are at an all-time high for the pharmaceutical industry. Drug development…
The advent of continuous data monitoring using wearable technology and other connectable medical devices has opened the door to new…
Cardiovascular outcomes trials (CVOTs) are some of the largest interventional trials being conducted, enrolling several thousand subjects, sometimes with follow-up…
Per the suggestion of regulatory agencies, there is an increased focus on the merits of adapting a risk-based monitoring (RBM)…
The development of therapeutic products balances benefits and adverse consequences, so research quality is required for the development of the…
To obtain drug approval from the US Food and Drug Administration (FDA), manufacturers must establish efficacy by providing “substantial evidence”…
The planning and execution of rare disease clinical trials involves unique considerations. Examples include the role of patient advocacy groups,…
Human challenge studies (HCS) were introduced as an alternative to community clinical trials for anti-infective agents and vaccines, previously performed…
The last few months have seen a battle build between the pharma industry and the EMA, following the issue of…
In November 2016, the ICH E6 (R2) Addendum to Good Clinical Practice was implemented, delivering a breath of fresh air…