The Current State of Clinical Information Systems

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 […]

Why Do 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

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

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

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 […]

(Few) Challenges in Clinical Trials

The process of achieving a particular goal is lengthy and complicated. Delivering Clinical Operations is no exception to this principle. Aside from requiring clinical operations expertise such as clinical operations management, clinical trials also need financial support, patient participation, technological knowledge, and regulatory clearances to function and succeed. These components are as vital as they […]

Ethical Concerns in Clinical Trials

Ethics is defined as the moral principles that a person follows in conducting a certain activity. It is the moral codes that influence an individual’s beliefs, behavior, and choices in life. In other words, ethics is the governing principles or standards of decency that a person adheres to. In today’s society, ethics serve as a […]

Factors in Clinical Trial Failures

90% of Clinical Trials fail. Even after all the investment in time and resources, only 1 out of 10 clinical projects passes testing and regulatory approval. According to Dr. Duxin Sun, a professor of Pharmaceutical Sciences at the University of Michigan, developing one successful drug through clinical projects takes around 10 to 15 years and […]

Successful Project Management in Clinical Research

“Management is, above all, a practice where art, science, and craft meet.” Henry Mitzberg claims that management is the convergence of different skills, knowledge, and discipline. These elements are being utilized to carry out whatever it is that an individual or group is managing. These key attributes can clearly define the outcome of whatever it is […]

Evaluating Clinical Studies

Evaluation is the act of critical examination of a program that involves collection and analysis of information about its processes, characteristics, and results. The purpose of evaluation is to assess or conclude about the effectiveness of a program or what improvements should be done to it in order to achieve desired results. To evaluate is to monitor a […]