How Changes in Practice are Changing Bleeding End Points in Coronary Interventional Trials
Cardiac catheterisation and coronary intervention both require catheters to be placed into arteries – engendering risk. In their paper, L.…
Orphan Drugs: R&D Challenges with Updates from Turkey and Middle East Countries
Rare diseases (RDs) are an important public-health issue and a challenge for the medical community. They are called ‘health orphans’,…
Import of Investigational Medicinal Products into Israel
Israel has a robust and growing pharmaceutical industry, particularly for biopharmaceuticals and advanced therapeutic medicinal products (ATMP). It is home…
The Role of Mobile Technology in Reshaping the Pharmaceutical Industry
With the growth of mobile devices, healthcare professionals (HCPs) and the general public are accessing and collecting medical information via…
CNS Clinical Trials in Russia
In Russia, most CNS clinical studies have been conducted in MS, epilepsy, AD, stroke, depression and schizophrenia. A number of…
New Standards in Alzheimer’s Disease Trial Design
Over the last decade, the only new treatment for Alzheimer’s to make it to market is memantine (Namenda™). The number…
Patient-derived Xenograft (PDX) Model: An Evolution in Oncology Drug Study
In order to address shortcomings at the discovery stage in oncology studies, PDX has recently emerged as the upcoming technique.…
Risk-sharing: Supplementing Clinical Trials for Payer and HTA Success
As the benefits of real-world data become more apparent, so too, do issues around its appropriate collection methodology and reliability.…
Is Risk-based Monitoring an Appropriate Methodology for Clinical Trials in Emerging Regions?
When it comes to emerging regions – where sites and monitors generally have less experience in clinical research than those…
Regulatory Framework for Developing Clinical Trials in Romania
The measure of Romania’s success as a clinical trials destination lies in the rapid evolution of the regulatory framework, which…