Pascal Lardier, Director International Events of Health 2.0, answers questions about the co-production of health by patients and physicians today and in the future. O...

The drug development industry has seen significant changes in the last ten years. Amongst those changes, pharmaceutical and biotechnology sponsor companies are outsou...

With the recent 2011 release of the FDA’s draft guidance on risk-based approaches to monitoring, the agency has sought to correct a long-standing misconception that 1...

Like many of us working in the clinical world today, the Clinical Research Associate is confronted with a dizzying array of technology solutions, all designed to make...

It is not a passing fad but a permanent shift. ePharma consumers are here to stay. It means that pharmaceutical and medical device companies must adapt to the new dig...

Type 1 diabetes mellitus is an autoimmune disease. As well as T1D, latent autoimmune diabetes in adults is also included in autoimmune diabetes. Latent autoimmune dia...

In early August 2011 the European Medicines Agency released a draft document entitled Reflection Paper on Risk Based Quality Management in Clinical Trials. Later the ...

ALS is a devastating disease affecting a wide range of individuals, from young adults to senior citizens. The progressive and highly debilitating nature of the diseas...

An ISS is an Integrated Summary of Safety, and an ISE is an Integrated Summary of Effectiveness. An ISS combines the safety results from different studies conducted i...