Orphan drugs are pharmaceutical agents specifically developed to diagnose, prevent, or treat rare diseases. These diseases, also known as orphan diseases, are conditions that affect a small percentage of the population. Due to the limited patient pool, the market for such drugs is typically small, making their development less financially attractive to pharmaceutical companies without […]
Me-Too Drugs vs. First-in-Class Drugs: What’s the Difference? Me-Too Drugs: Me-too drugs are compounds that are chemically or structurally similar to an existing, approved drug (known as the first-in-class drug), and are developed to treat the same condition. The main objective of me-too drugs is often to improve on the original drug by offering slight […]
Pharmaceutical companies undertake a thorough evaluation before initiating the development of a new drug. This decision-making process hinges on several critical factors: 1. Unmet Medical Need Companies prioritize conditions or diseases where current treatments are inadequate or unavailable. Addressing an unmet medical need not only helps improve patient outcomes but also increases the likelihood of […]
The drug development cycle from discovery to new drug application (NDA) approval and ultimately hitting the market is intricate; it can take an average of 12 to 15 years to receive FDA approval. Additionally, the FDA holds the right to reject the NDA even after years of work. Here’s a detailed layout of the drug […]
From my personal experience working as a Clinical Research Coordinator (CRC), I can confirm that CRCs are the backbone of clinical research. They are also sometimes known as a Study Coordinator. Their role varies slightly based on how big the study team is and how big the organization they work for is. Other variable factors […]
Career progression in the Clinical Research industry looks different for everyone depending on their interests, education, and goals. Some require a bit more travel and hours than others. Generally speaking, the industry side pays more while the site side is more morally rewarding. Many people choose to work for sponsors because they have a great […]
In clinical research, a Contract Research Organization (CRO) is a company typically hired by a sponsor to manage clinical research sites conducting a trial, ensuring data integrity and patient safety. Purpose of a CRO: A CRO acts as the intermediary between the sponsor and the site. They ensure adherence to the study protocol and address […]
A clinical study protocol in clinical research outlines the entire study design, objectives, and methodologies. It typically contains study details that are pertinent to follow when conducting a clinical trial. If any deviations from the protocol occur, a protocol deviation form must be filed and submitted to the appropriate authorities. It’s important to focus on […]
Clinical sites are where studies are conducted, often in hospitals, private clinics, or specialized research facilities. These sites are responsible for recruiting participants, collecting data, and ensuring the trial is executed per protocol and regulatory standards. 1. Study Feasibility and Site Selection Before a site is selected, it has to go through a few steps. […]
To break into clinical research, it’s essential to grasp the fundamentals, including the educational qualifications needed, the roles of clinical sites, CROs (Contract Research Organizations), and sponsors, as well as the involvement of pharmaceutical, biotech, and medtech companies in the field. Additionally, understanding the various roles within clinical research and their responsibilities is crucial. To […]