From an all-inclusive, exhaustive report to a high-level, executive summary with in-depth observations, the amount of detail required in an audit may vary. While a report may only include a range of observations, it may also provide a list of every document reviewed, describing every process reviewed in detail, as well as any audit observations.…
If you have been invited to enroll in a clinical trial, there are many questions that may come to your mind. As you may know, clinical trials are a great way to explore the efficacy of new medical procedures, pharmaceuticals, and devices. They help improve healthcare, which is ultimately beneficial to the patient population. In…
Today, the importance of harnessing clinical trial data has never been more relevant. Heathcare practitioners strive to deliver therapies that improve the lives of patients. However, the clinical data we produce can significantly impact our success in accomplishing this goal. A high-quality clinical data package is an important requirement for a new therapy to acquire…
Since technological advancements have allowed for more data-driven clinical research, centralized monitoring in clinical trials has become an important approach in off-site and on-site monitoring plans. Here, we discuss the importance of centralized Monitoring in clinical trials for data integrity in clinical trials. 1. Centralized Monitoring in Clinical Trials Effect on Cost Efficiency Clinical process…
Sponsors and sites struggled with clinical trial diversity way before the Coronavirus pandemic began. Approximately 20% of new drugs have different effects depending on an individual’s race. This makes it important for newer treatments to be tested on a diverse patient population. Yet disabled, elderly, Hispanic, and African American patients are typically underrepresented in clinical…
Clinical trial material management is an important but not often publicized issue in clinical trials. Clinical trials are a crucial part of the healthcare industry. Whether you’re a drug manufacturer or a medical device producer, you’ll need to undergo clinical trials before you can release your product to the market. Otherwise, the Food and Drug…
The clinical research industry has seen a remarkable technological transformation in the past decades. Impactful technologies have significantly changed the clinical trial landscape. Clinical Trial Software, often referred to as or EDC (Electronic Data Capture) systems for clinical trials are at the forefront of this technological revolution. Also, the ongoing pandemic has accelerated the need for…
Today we make an argument that clinical research needs more awareness. While modern clinical trials may be a recent phenomenon, clinical research has been around for centuries. Scientists and medical professionals devoted time and resources to learn about biology, anatomy, etc., to understand diseases better and improve quality of life. However, despite clinical research playing…