News
New Clinical Research E-Source Introduces Tablet-Based Data Collection
November 14th 2016Clinical Research IO (CRIO) is a website and Android app that allows users to conducts trial visits on a tablet or desktop, design source online, manage and schedule subjects and communicate with study monitors remotely.
Parkinson’s Patient Benefit-Risk Preference in Trial Design
November 8th 2016A new group of collaborators has formed to determine the benefits and risk tradeoffs Parkinson’s disease patients are willing to make for a potential new therapy. Dr. Brett Hauber of RTI Health Solutions spoke to us about the collaborative.
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.
