It’s not surprising that the current pandemic environment is impacting the way clinical trials are conducted. From the beginning, many adjustments needed to be made to ensure patient safety and the integrity of the data collected.
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Many product and service delivery models have evolved to meet changing market conditions brought on by the world-wide pandemic. Clinical trial logistics are no exception, and the way future trials are conducted may be very different due to lessons learned over the last year.
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Historically, companies selling implantable medical devices in Europe have not been required to provide patients with device-specific information. In the event of a medical emergency, not having immediate access to this critical information predisposes the patient to a variety of unnecessary operational risks.
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Patient safety during clinical drug administering remains the most important aspect to the clinical trial industry, especially during a global pandemic that has targeted the older generation and individuals suffering from preexisting conditions or immune deficiencies.
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Everything was running smoothly in the run-up to launching the new drug formulation. Development of the drug finished ahead of schedule; regulatory requirements had been met; and intellectual property rights secured. Next up were the all-important clinical trials to demonstrate the efficacy of the drug.
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Clinical Trial labels have evolved over time to accommodate changing clinical trial material (CTM) containers, as well as packaging and storage environments. Today’s manufacturing equipment has also opened new opportunities for complex label designs. Regulatory agencies around the world each have their own ideas around what needs to be included on a label, or what parts of the packaging need to be labeled.
The study and engineering of healthcare remedies began long before the mid 1800’s, but it’s around that time organic compounds like morphine became available commercially as a source of pain relief. The first rudimentary clinical trials occurred during the 1500’s, but it wasn’t until 1943 in the UK when the first double blind, regulated clinical trial took place. Since then, discoveries and breakthroughs in drug remedies have been occurring more frequently, and with greater complexity when it comes to molecular structure.
All good businesses recognize the need for continuous improvement. If you don’t continually look for ways to make things better, your competitors can leave you in the dust and you can ultimately lose your customers and your business. There are many ways to analyze processes in trying to continually improve. At AWT, Kaizen (a Japanese term meaning, “Change for the Better”) has been a major method used to dissect and evaluate processes for continuous improvement and now Citation Healthcare Labels (CHL) has begun utilizing these beneficial methods.
One of the biggest pain points facing Clinical Trial timelines today is the booklet labeling process. Labels are the last component needed before packaging can be completed, and there is often a late-in-the-game scramble to get booklet labels to the packager quick enough to avoid patient impact. Booklet labels tend to be an exasperating component.
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Advances in technology over the past decade have catapulted the world forward in every aspect of our economies. The network of shared knowledge is growing exponentially and with it, new breakthroughs in drug development are constantly evolving. What has not changed however, is the 20 year patent life on new drug discoveries. As a new drug developer, you face daunting odds to bring your drug to market in a safe and just as importantly, timely manner in the eyes of the stakeholders.
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Our customers have told us that label terminology can be confusing. In an effort to make things easier for our customers, we have put together a glossary of some of the most common terms that we use on a daily basis.
ADHESIVE: Located between the face stock and liner, adhered to the back of the face, the adhesive bonds the face to the product with varying degrees of permanence.
APPLICATION TEMPERATURE: The temperature of the product the label material is applied to at the time it is applied.
BLEED: Printing that goes beyond the trim edge to ensure complete coverage of ink.
So far, retirement has been everything I have hoped including some trips, some paddling, chasing deer, a bit of volunteer work, and adult beverages whenever the urge strikes. I do have to suck it up and put in about three days a month working in the sticker business, a schedule I kick myself for not implementing years ago.