The Institutional Review Board (IRB), also known as the Institutional Ethics Committee (IEC) or Ethics Review Board (ERB), is a cornerstone of ethical clinical research. Its primary purpose is to…
Clinical research involves the participation of human volunteers and therefore requires strict ethical oversight to protect their dignity, rights, safety, and well-being. Ethical guidelines act as the foundation for responsible…
Good Clinical Practice (GCP) guidelines ensure that clinical trials are ethical, scientific, and protective of participant safety. However, the successful implementation of these guidelines can be difficult, especially in developing…
In India, the conduct of clinical trials is governed by strict regulatory standards to ensure participant safety and scientific integrity. The Central Drugs Standard Control Organization (CDSCO), under the Ministry…
Good Clinical Practice (GCP) is the global ethical and scientific quality standard for conducting clinical trials involving human participants. The International Council for Harmonisation (ICH), previously known as the International…
Once a drug is approved and enters the market, the responsibility of monitoring its safety does not end. In fact, this is the stage where real-world evidence becomes crucial. Post…
The development of a new drug involves a rigorous and carefully monitored research process. After successful preclinical studies, a drug enters human testing through clinical trials. These trials follow a…