Not so many years ago, if you posed this question to an experienced Clinical Operations Professional, you may have gotten responses like: lots of Post-It notes! Or: a miniature stapler! In today’s healthcare world, where paper remains a staple, but EMR and global connectivity increasingly digitizes our work, these tools are not enough. Today’s CRA relies upon both physical and electronic tools to do their
First, some monitoring basics…
Sponsors of human clinical trials that evaluate new drugs, biologics, and medical devices are responsible for maintaining a high standard of quality and ethics. This means that they must ensure that study participants’ rights, welfare, and safety are protected, and that accurate data are collected, analyzed, and reported to the U.S. Food and Drug Administration (FDA). FDA requires that sponsors use monitoring
This series will review and elaborate on the glossary terms listed in the Good Clinical Practice (GCP) Guidance adopted by the United States Food and Drug Administration (US FDA) for conducting clinical trials.
Today’s blog is entry #1 addressing tips and tricks for efficient travel – we like to call it:
This is our first entry in the “Hart’s Voyagers” blog series dedicated to the traveling CRA looking for some simple ways to stay on top of their daily health and well-being.
As busy clinical affairs professionals ourselves, we understand how difficult it can be to stay healthy in the fast-paced, demanding world of clinical trial operations. Whether you are a Director of Clinical Affairs, on the road as
Clinical trials are complex and costly. With 2010 estimates of average total expenditures for a pivotal clinical trial in excess of $40 million for a PMA product and nearly $11 million for a 510(k) product, sponsors understand the value of executing an efficient, high quality trial.
With the ever-increasing costs associated with conducting clinical trials, many medical device and pharma companies continue outsourcing various operational pieces to contract research organizations (CROs) and other augmentation service groups. By doing so, they are often saving money and the trials are typically completed faster (up to 30%) than when kept in-house (American Pharmaceutical Review ).
If you’re the owner or CEO of your company, it’s vital you take a look at how engaged your employees are. Your employees are the foundation and often the face of your company. The most engaged employees are the ones who love their job and feel like they’re making a difference. They are also the ones who will motivate and inspire others. This engagement may
What drives change? Sometimes it’s the economics of supply and demand, unexpected growth or industry climate shift – sometimes unidentified sources can tip these scales. In the case of Hart Clinical Consultants (HCC), our change is due to a purposeful rebranding and evolution to create value.