Clinical Oversight

Recently, U.S. Food and Drug Administration (FDA) issued Warning Letters to pharmaceutical companies and their outsourcing partners have resulted to focus on clinical oversight. The letters have galvanized sponsors to take a close look at their ability to withstand such regulatory scrutiny internally, and to develop proactively their internal capabilities and infrastructure



cQRM (clinical Quality Risk Management)

cQRM is a risk management methodology that applies quality risk management to clinical trials. It focuses on proactive risk management in clinical research and helps in completing clinical trials successfully within the timelines and budget.

 

Carcinoid Syndrome - Research Perspective

Carcinoid syndrome is a collective of symptoms that occurs in patients with Carcinoid tumor. It is caused by excessive endogenous secretion of hormones mainly serotonin and kallikrein. The syndrome includes flushing and diarrhea, and, less frequently, heart failure and bronchoconstriction.