When any new drug, vaccine or medical product is produced, it must go through rigorous testing before it is submitted to the regulator for approval. This is the same for new food products that are due to be released for human consumption. The usually process for drugs and medical products is the design phase, animal testing phase, human clinical trials then the submission stage. The average time that this whole process takes can range anywhere from 10 years right up to 25 years. This overall timeline very much depends on the type of drug that is being developed, the availability of appropriate test subjects, and the time that the company can accumulate and process all of the data involved in the testing and submission of the drug in question. The cost to the company that is developing the drug can also vary, but the estimated cost to the pharmaceutical company is around $2.6 billion. This is a massive amount of money and an extensive amount of time to get the drug to the approval stage, and there is no guarantee that it will even be approved by the regulator. There are a few modern systems in place that can help these companies keep their activities efficient, and CDISC training can help developers log data in an efficient way.
What is CDISC Training?
CDISC training is essentially hands on training that teaches people how to use the CDISC system. CDISC stands for Clinical Data Interchange Standards Consortium, and refers to the standardised way of sharing data between companies, other organisations and regulators. This standardised data method supports the collection of data from protocol stage through to analysis and then onto reporting the data and submitting it to the regulators. While this may sound relatively straightforward, the amount of savings that can be felt across a number of areas is staggering. Using these systems have been shown to decrease the resources needed by up to 60% across the whole collection stages, and up to 90% in the initial start up stages. For pharmaceutical companies that often have a 10 year long minimum time frame on their development process, anything that can be done to cut this down is incredibly valuable. Not only that, if money can be saved at any point during the process then the final costs are reduced and the cost to the consumer is also reduced.
Why Is It Important?
Many people will be reading this thinking, ‘but why does all this matter to me?’ Well the simple answer to this is the fact that, as we all know, healthcare in this country is not cheap, and there is an increasing amount of people who struggle to have access to some medical services. This includes medicine and drugs that they might need for treatment as well as their well being. Developing a new drug or medicine is incredibly costly, and these costs are being felt by the people who need them most. That is why anything that can be done to save money across the process will mean that the consumer will have more access to these medicines, and CDISC training is doing this.