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 a regional CRA, or a Clinical Site Coordinator enrolling patients, here are three easy tips from the team at Hart Clinical team to help you stay healthy this summer.
- Take a water bottle with you. Staying hydrated is one of the most important things you can do this summer. According to the American Heart Association, staying hydrated is critical for your heart health. When you stay hydrated, your muscles, including your heart, don’t have to work as hard.
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 stem from their own satisfaction and career choice, but as an employer, you have the tools to see that your employees are fully engaged.
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.
If you’re reading this, you’re likely not new to this industry. But, just in case, a CRA’s primary job responsibility is to monitor clinical trials, ensure the protocol is followed and that all data collected is protected and verified. Depending on level of experience and protocol requirements, CRAs may also handle case-proctoring and device training. The latter is often the case of CRA’s that work with Hart Clinical Consultants.
If you’ve been following our recent blog entries, you know the background and premise behind the Hart Healthy Challenge during the month of February. In short, we believe a company’s internal culture can have a discernable effect on those that work within it. By design, HCC levels great value on how physical well-being can influence work-place and staff “barometers.” Using this philosophy as a motivator, our leadership team distributed Jawbone Up24 fitness tracking devices to all clinical research associates (CRA). Thus began a friendly competition to achieve the most steps, noting milestones and earning simple (but attractive!) prizes along the way. At the end of the month, first and second place winners received a predetermined amount of funding to donate to a local charity of their choosing.