Author page: Digital Spring Bio Solution

Clinical trial conduct requires efficient supply-chain logistic support to manage study timelines. Risk-based optimization helps to achieve efficiency, cost and time effectiveness in this important activity. Every clinical trial requires varied supplies specific for the study and these clinical trial supplies could come from various sources. It is important to identify and control the potential constraints and hazards…

Biological sample management refers to the methodical and organized processing, preservation, and disposal of products obtained from biological source and classified as biological products. It also includes biological specimens such as tissue, blood, and body fluids. Biological products deteriorate at ambient and high temperatures and lose their potency and intended pharmacological activities. In order to preserve the integrity…

IPR is an abbreviation for Intellectual Property Rights that is legally bestowed upon for 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 innovation.…

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 European Medicinal Agency (EMA) in the European Union. The RLD Drug continues to remain as a standard or benchmark for the generic copies to obtain the licensing once the patent period…

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 demonstrated efficacy and safety in the…