Per the suggestion of regulatory agencies, there is an increased focus on the merits of adapting a risk-based monitoring (RBM) approach. Effective RBM reduces costs, ...

The development of therapeutic products balances benefits and adverse consequences, so research quality is required for the development of the new therapeutic. Astute...

The planning and execution of rare disease clinical trials involves unique considerations. Examples include the role of patient advocacy groups, the value of outcomes...

Human challenge studies (HCS) were introduced as an alternative to community clinical trials for anti-infective agents and vaccines, previously performed in regional ...

The last few months have seen a battle build between the pharma industry and the EMA, following the issue of new guidance promoting greater transparency in clinical t...

In November 2016, the ICH E6 (R2) Addendum to Good Clinical Practice was implemented, delivering a breath of fresh air for clinical trial sponsors and CROs who have b...

There is a great deal of emphasis on streamlining the regulatory process to get important drugs to subjects who need them expeditiously. This is of increasing importa...

Declining healthcare spending combined with increased pressure on the HC system budget is creating an incentive for patients to consent to new treatments, and fosteri...

Since 2007, new drugs need a paediatric investigation plan (PIP) for EU registration. Without a PIP accepted by the European Medicines Agency (EMA)'s paediatric commi...