A Named Patient Program (NPP) is a unique access program that enables patients to get special access to orphan drugs and unlicensed drugs that are either unavailable in the country or not yet licensed for sale in the country.  NPP is frequently used for drugs that are currently in the clinical trials stage that have…

The process of obtaining a reference drug or comparator drug product for use in a clinical trial is referred to as comparator sourcing for clinical trials. A comparator drug is often required as a control/ reference treatment group in clinical trials to examine the safety and efficacy of the…

A patent is an intellectual property that protects inventions from copying and reproducing by any other entity.  It grants the patent holder the exclusive right of about 20 years to prevent others from making, using, selling, or importing the invention without their permission. In order to qualify any invention to be patentable, it must meet…

Comparator sourcing refers to the process of identifying and selecting the most appropriate comparators for a given study or analysis. A comparator is a reference group that is used as a basis of comparison in a clinical trial, observational study, or other type of research. The selection of a comparator is an important consideration in…

Comparator drug sourcing refers to the process of acquiring the comparator drug for use in clinical trials The sourcing process involves identifying a suitable comparator drug, negotiating with suppliers, ensuring regulatory compliance, and managing the logistics of delivery and distribution. A comparator drug is a medication used as a standard or control in a clinical…