Various Types and Phases of Clinical Trials

Various Types and Phases of Clinical Trials

Clinical trials are a vital step in developing new medical treatments. They evaluate the safety and efficacy of new drugs, medical devices, and other therapies before making them available to the general public. Clinical trials are conducted in several types and phases, each with specific objectives and requirements. Understanding the different types and phases of […]

Overview of Functional CROs in Clinical Operations

Overview of Functional CROs

According to Business Wire, nearly three out of four clinical trials are conducted by contract research organizations (CROs) [1]. Every clinical trial involves complex overlapping processes and also requires expertise and significant experience. For this reason, CROs form an important part of clinical trials.   CROs support the medical and biotech industries by providing clinical […]

Significance of Clinical Trials in Healthcare

Significance of Clinical Trials

In evidence-based medicine, clinical trials are critical because they help in testing out new medicines. These include possible treatments or even vaccines. In most cases, clinical trials involve a significant number of people, typically called human volunteers. These volunteers are imperative to ensure that the new intervention is a safe and effective one.   Some […]

The Functional Service Provider Model

Functional Service Provider Model

Introduction The rise of Functional Service Providers (FSPs) in the field of clinical research implies that biopharmaceutical companies embrace and adapt to change and innovations. Over the years, it is undeniable that conducting a clinical trial has become more challenging, costly, and complex. For companies and organizations that have their in-house clinical research operations department, […]

The Current State of Clinical Information Systems

Clinical Information Systems State

Introduction Errors are always costly. In fact, mistakes can cost a fortune. In clinical science, oversight doesn’t always translate into financial loss. Sometimes, accumulated missteps can lead to unwanted fatalities. In a paper published by Andel, Davidow, Hollander, & Moreno, “The Economics of Healthcare Quality and Medical Errors” (2012)[1], the cost of medical errors in […]

Frequently Asked Questions in Joining a Clinical Trial

Joining a Clinical Trial FAQs

Introduction Contrary to popular belief, clinical trials are not entirely new. In fact, it has been around for almost 300 years. One of the earliest known clinical trials in the modern era is performed by a physician named Dr. James Lind. In 1747, Dr. Lind performed a comparative trial about what might be the most […]

Why Do Clinical Trials Fail?

Why Clinical Trials Fail

When clinical trials fail, not only the sponsors but also the patients lose something. The average overall likelihood of approval (LOA) by the FDA from Phase 1 of clinical trials was only 9.6% [1]. Only one out of ten trials make it to approval and commercialization. In addition, the estimated amount of clinical trial cost […]

Considerations in Clinical Research

Considerations in Clinical Research

Giving fact-based answers to crucial medical questions is the essence of clinical research. To do this straightforward yet complex objective, the clinical operations department should function in accordance with solid scientific approaches. Producing authentic and well-grounded information is one of the many purposes of clinical trials. The goals of a clinical trial are often shaped […]

Barriers to Conducting Clinical Trials

Barriers to Conducting Clinical Trials

The road to success is never smooth nor easy, and the same can be said in conducting clinical trials. Before announcing that a drug or a treatment is safe for public use, the biotech and pharmaceutical industries must first overcome countless barriers. For most clinical operations, these barriers are frontiers of the study, ensuring failure […]

Benefits and Risks of Clinical Trials

Benefits and Risks of Clinical Trials

Despite scientific breakthroughs, stellar technological advancements, and strict health authority regulations, the general public is still skeptical and frightened when the topic of clinical trials  is on the table. Why wouldn’t they? No one wants to jeopardize their health for unproven medications or methods. Moreover, most of us do not want to feel like laboratory […]