Getting new drugs from the lab to the stores is a long and complicated. It needs to be to protect the public from bad pharmaceutical products. Since 2010, doctors in hospitals have ordered at least 271.4 million prescriptions for their patients. Doctors out of the hospital setting have prescribed 285.1 million prescriptions medications in that same amount of time. Companies dealing with clinical trials project management know how much is involved in the process and how many details need to be taken care of. These are the phases of the process.
In the first phase, the safety of the product, drug or device is carefully assessed. This phase generally takes at least a few months to finish. Typically, between 20 to 100 people are involved here. These are healthy people. Researchers look at how the drug impacts the human body. They examine how the drug s processed, absorbed and, finally, excreted. Researchers look for any side effects the medication or the device cause. Most drugs that are being developed will pass this phase. This is also the time to look at the dosage for the drugs, which often needs to be tweaked during the phase of the process. This is a crucial stage for the clinical trials project management process. It is important for the drug to be delivered exactly the same way researchers expect to be taken. This means that experts from pharmaceutical packaging companies should be involved sooner than later in the drug development process. There are a lot of options for pharma packaging that include blister packaging and
The next phase looks at how effective the medication or device is. This is a more lengthy phase in the process. Phase 2 can be just a few months long or it can last for several years. It typically takes up to several hundred participants. Phase 2 often involves randomized trials where one group is given the actual drug while other patients receive a placebo. There are a lot of clinical trials that are called “blind studies,” meaning neither the patients nor their doctors know who is getting the real drug vs. the placebo. Only one third of drugs that enter this phase get any further in the process. This is also when the Food and Drug Agency (FDA) look at the comparison of the real drug and the placebo.
The phase that follows will include even more patients. The number ranges from a few hundred to a few thousand people. This is also a longer phase. It can last up to a few years. This gives the FDA and the pharmaceutical company more insight into how safe and effective the drug or product is. This is the phase that brings the pharmaceutical company to the stage where they can get approved by the FDA to market the product to the public. Somewhere between 70 and 90% of drugs that enter phase 3 will make it through the clinical trials project management. This is much more complicated part of the clinical trials project management.
The last step is often referred to as the “Post Marketing Surveillance Trials.” These trials are done after the drug or device has been approved for sale to the public. There are a number of reasons to do this. In the first place, pharmaceutical companies look at the long term impact of the drug or device in question. They look at their products and watch how they match up with other drugs and products that are on the market. Lastly, they can look at the quality of life for the patients taking the medication and how effective the drug is. Drugs can still be pulled from the market in this fourth and final step in the clinical trials process if the drug or device is found to harm people who take it and for other reasons.
When dealing with the clinical trials management process is long and complex. Because counterfeit drugs and devices cause many problems, getting the right pharmaceutical track and trace packaging is critical to the safety of the medication in question. This is why it is good sign on with a drug packaging company early on. They may have ideas that are needed for the process.