One area in the clinical trial process that has been identified for improvement is risk-based planning and management. Monitoring and managing risk has always been a ...

CDSIC is meant to enable you to collect, store and transfer clinical data in a way that makes them easily usable on a large scale in an unambiguous way. Collecting da...

Monoclonal antibodies (mAb) are among the most promising biologic drugs currently on the market for treatment of life-threatening diseases. The selectivity and specif...

Pharmacovigilance will always be about protecting patients. The discipline is rapidly evolving into something greater than regulatory compliance; increasingly, pharma...

The history of clinical trials in Slovakia goes back to the mid- 1990s and the quality has been improving since the beginning. In the last couple of years we have rea...

Influenza viruses are commonly used in human challenge studies. Both the viruses and the disease they cause are well understood, and the induced illness is short-last...

Interest in the development of medicines to alleviate or cure rare diseases has increased due to positive actions taken by global regulatory agencies. Alastair MacDon...

As defined by section 351(k) of the Public Health Service (PHS) Act, a biosimilar product is highly similar to its reference product, “notwithstanding minor diff eren...

Cost pressures associated with the development of new medications are at an all-time high for the pharmaceutical industry. Drug development costs in general are risin...

The advent of continuous data monitoring using wearable technology and other connectable medical devices has opened the door to new insights into the lives of patient...