Supply Chain Strategies for Adaptive Clinical Trials
Adaptive clinical trials are defined as studies in which accumulating data is used to decide how to modify aspects of…
Eletronic Health Records in Clinical Research
The first reference to the creation and usefulness of a patient electronic medical record may have been the visionary writing…
Know Your Audience: Clinical Trials with Paediatric Populations
In recent years, the FDA has placed greater emphasis on the need for paediatric studies. As Shawn Patterson Baker and…
Biobank Ethics Committee for Approval of Biobanks
The Human Research Ethics Committee (HREC) at University of the Witwatersrand (WITS), has regulated that all biobancks being accessed by…
Advances in Allergy Testing: Component Resolved Diagnostics
Immunoglobulin E (IgE)-mediated allergic conditions are increasing worldwide. They affect the quality of life of millions of individuals, causing enormous…
Three Myths about Clinical Trials in Russia
With its population of 145 million and total pharmaceutical sales of almost 29 billion dollars in 2013, Russia today is…
A Survey of Global Resources for Clinical Trial Awareness and Education
Often asked ‘How do you recruit patients?’, Helen West of MMG explains in her article that the emerging focus on…
Patient Safety Narratives in Clinical Studies
An important part of clinical study reporting, safety narratives should be prepared for all phases of clinical studies, whether conducted…
Minimisation of Systematic Deviations: An Example of Risk Management in the Conduct of Clinical Trials
All sponsors try to optimise their resources when conducting clinical trials, and sometimes the desire to reduce study budgets leads…
Regulatory Requirements for Registration of Pharmaceutical Product in China
China’s pharmaceutical market has expanded dramatically in the past twenty years and is expected to become the largest in the…