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Original receipt sample for Research and Development

In order to understand what Global Clinical Connections does and how we are involved, I think it is first important to understand the research and development process, in other words, R&D. Let's start with the research side of things. It all begins in the lab. In research laboratories, thousands of compounds are tested in cells, tissues, and small mammals. They are usually a couple milligrams or micrograms of material tested in a high throughput screen. This is done to identify which drugs have activity and which drugs do not have activity. From these materials, out of maybe ten thousand drugs, there may be 30 drugs which are active. From the thirty drugs, there is another round of screening with medium sized mammals like dogs or cats where we can narrow down the drug activity. Narrowing down from maybe thirty to five, we can look at larger animals such as monkeys, cows, pigs - which are models to mimic man's physiology - and so to see which ones are the continued actives. The reason the compounds are screened through all of the layers is to avoid testing on all ten thousand compounds and avoid the cost of testing many compounds on more expensive animals. We are trying to identify the final compounds going to preclinical evaluation, another costly process. Preclinical evaluation looks at toxicology and drug metabolism. Compounds at this stage are tested to see if they are toxic to specific organisms, and to see how the drugs are metabolized in the body. These tests are regulated under good laboratory practices or GLPs. Examples of local companies which perform these kinds of tests is MPI and PharmOptima. Once these compounds complete preclinical evaluation, then testing continues in humans and we get into the process called development. While research stage tests primarily on animals, development primarily works on testing in humans. This happens in four phases. Prior to be able to test in humans, all research data is submitted to the FDA along with the protocol for Phase I and the label for the drug product. The document is called an IND - investigational new drug application. This could take up to six months for approval, plus answering the questions that the FDA has. Once the IND number is given, the human testing can begin 30 days after receipt of the IND. In the Phase I study, which is the first in human, healthy volunteers are sought for the study to make sure the compound is safe and monitor the pharmacokinetics of the drug. The patient is monitored for side-effects. These studies can take 6 months to 1 year to complete. Once we complete Phase I successfully, Phase II begins. The first Phase II A study is called proof of concept study. Patients affected by the disease are administered the compound. Phase II A studies examine the efficacy and safety of the drugs. Phase II B studies look at dose ranging of the drug. A positive proof of concept study result is the single most important criteria in proceeding next for full development. Phase III is often called full development. It is a global study run for thousands of patients at multiple sites and countries. Long term safety, efficacy of the drug, and optimal and best dosage forms are tested. Does it offer advantages over the competitor? Typically in a Phase III study, there is the placebo, the drug itself, and then also a gold standard comparator. The drug is tested to see whether it will offer equivalences or advantages over the gold standard. After Phase III is completed, there is a submission of all the data in preclinical and Phase I-III data in a document called the NDA - new drug application. After that approval - again, it will take some time - the drug will be able to be sold commercially by the company. There is another type of study called a Phase IV study which looks at long term effects. E.g., does chronic exposure cause negative side effects? For what else can the drug be used? In the development phase, Phase I-IV are regulated under good manufacturing practices and good clinical practices (GMPs and GCPs). The entire process of research and development can take up to twelve years which makes sure that a drug is safe and effective before administering it commercially to patients. We at Global Clinical Connections make sure drug supplies are provided for Phase I-IV clinical trials. We get the right drug to the right place at the right time. We oversee manufacturing, packaging, and labelling of drug, biologic, and medical device. And we oversee the GMP processes involved with the supplies. We give confidence to the site that things are done in ance with federal regulations, the SOPs, and guidelines. So give us a try!