IPR is an abbreviation for Intellectual Property Rights that is legally bestowed upon innovators to protect their intellectual innovations. IPRs are classified into three types: patents, copyrights, and trademarks. Patents- Patents are a collection of exclusive rights awarded to an inventor or licensee for a limited time in exchange for the general disclosure of the…

A Reference Listed Drug (RLD) is the original, innovative, branded product that has been approved by regulatory agencies such as the Food and Drug Administration (FDA) in the United States and the European Medicinal Agency (EMA) in the European Union. The RLD continues to remain as a standard or benchmark for the generic copies to…

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…

Why Comparator Sourcing Matters In today’s clinical research environment, comparator sourcing has evolved into a strategic function. Selecting the right comparator impacts not only regulatory approvals but also patient safety and trial timelines. As clinical trials become increasingly global, choosing and procuring appropriate comparators—whether for oncology, rare diseases, or chronic conditions—requires deep planning and expertise.…

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…