Transparency: The EU Prospective
November 3rd 2016In 2014, EU Regulation n.536/2014 represented a significant step toward transparency of clinical trials in Europe. However, despite the EMA’s policy 0070, which reinforced this concept, several aspects remain to be determined or evaluated, leaving room for additional requirements and local interpretation.
Centralized Monitoring for Improving Investigational Sites and Oversight Performance
November 3rd 2016Centralized monitoring is a suitable way in which sites can identify and control investigational risks while improving performance. This new approach can not only help sponsors to monitor site performance, but also facilitate proper oversight resulting in good ROI.
Rare Disease Research: It Pays to Engage
November 2nd 2016With pursuits in rare and orphan disease beginning to move more into the drug development mainstream, the opportunities and challenges in patient engagement and trial execution for these conditions are ever-evolving, as one strategy expert in the field discusses.
Biosimilar Trials Differ Notably from Innovator Studies
November 1st 2016FDA officials agree that large comparative clinical trials defeat the purpose of the abbreviated development program for biosimilars. Clinical testing is expected to gain market approval for most biosimilars, while emphasizing significant differences in developing biosimilars and innovator therapies.
Why Pharma Should Be Looking to Aerospace
November 1st 2016The pharma and aerospace industries share similarities whereas both are highly regulated, risk adverse and fast-paced markets. However, if there’s one thing that pharma companies can learn from the aerospace industry, it’s their approach to operations.
Antidote Incorporates Patient Centricity in Subject Enrollment
October 26th 2016The FDA’s launch of patient centric initiatives has led the industry to gear towards incorporating the patient’s voice in medical product development. Tom Krohn of Antidote discusses his company’s patient centered approach towards clinical trial matching by focusing on the patient.