Clinical Trials OutsourcingHow Necessary Is It?


Blister card packaging

Clinical trials outsourcing is sometimes done by pharmaceutical companies for several reasons. To begin with organizing clinical trial requires complex clinical trials project management. There are an indeterminate number of steps that need to be taken and each one must be closely supervised. These steps include clinical packaging, labeling, supply chain logistics, and distribution, not to mention return drug accountability and proper disposal of returned drugs. Very often the activities involved in a clinical trial will amount to more than can be handled within the organization; hence, clinical trials outsourcing will take place. Many pharmaceutical and packaging companies find that clinical trials outsourcing makes it easier to keep track of each step as it takes place, thereby creating a more successful testing ground.

Packaging for pharmaceutical products is always being examined and improved upon. Statistics show that within the past 30 days, nearly half, 48.5%, of people in the United States have used one or another prescription medication. With so many people undergoing some type of drug therapy, the packaging of the product is almost as important as the product itself. Medications must be protected from outside contaminants that could cause an issue for the patient. They must be sealed against tampering, and the packaging must be childproof.

Medical packaging companies provide several common ways to package medications. Blister packaging is one way, as well as bottle packaging designs, syringes, and tubes. Pharmaceutical packaging companies provide services such as bottling, patient kit assembly, pouching, carding, and more. Blister packaging is typically the way unit dose medications are packaged in the U.S. Moreover, there are different options that can be used for blister packaging using containers, style, and color.

Bottle packaging companies will bottle medications in the form of pills, powder and liquid, gel caps, tablets, and caplets. Bottles are filled by large and small format slat filling and electronic filling systems. Almost always any pharmaceutical bottling company will be able to handle any kind of packaging. Creams, ointments, and powders can be packaged in sachets, pouches, and stick packs. They are usually opened by peeling, and are always child resistant. Medications offered in pouch packaging are often used for measured doses, making it easier for the patient when dispensing the product. Prefilled syringe packaging is a very cost effective way to offer patients medication that is already measured and prepared. Sealed and ready to go, it is often dispensed in a patient kit according to the specifications of medical professionals.

Pharmaceutical serialization is essential to the safe distribution of drugs. Tracking must be carefully done of each product as it goes from manufacturer to consumer. There is a protocol that must be followed, as these medications can change locations up to ten times before being sold to customers. There must be ways to identify that the product is the legitimate, original merchandise that came directly from the manufacturer through each step down the line. The work involved on the business end of serialization is extremely heightened and intense because of the fact that many drugs can so easily be duplicated; therefore, by the time the product hits the market, the price is typically quite high.

There are so many details intertwined with manufacturing and packaging in the pharmaceutical industry that the level of security is always very high. As mentioned earlier, many drugs are easily reproduced; therefore they are tracked right down to the bottom line. The security numbers given to each product are unique and, therefore, must be carefully recorded and stored by each person on every level. Each product, according to their particular numbers, must be easily traceable.


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