There is a long and largely unseen process between when a drug or medical device is initially designed and when it appears in commercials or is prescribed by a doctor. A series of intense investigations into the effectiveness and safety of the drug or device is carried out through the process of clinical trials. Groups of dedicated and experienced clinical research investigators, who are all experts in their fields, carry out these trials.
One of the early stages of the clinical trials process is the assay development stage. This is the point at which the trial organisers and designers decide what form the trial is going to take. Understanding the drug or device and how it works is important at this stage. A deep understanding of the drug or device’s working and process is needed to be combined with a broad knowledge of different analysis techniques and standards.
The assay development phase also has to take into account various legislative standards that are set not only in the country where the trial is taking place but also where it is to be sold. Fortunately, many of these regulations and laws are being standardised globally but it is still a factor to consider.
The regulatory requirements result in an additional load of paper work on top of the substantial amount already required to simply record the methods, conditions and results of the investigation. This highlights the importance of administration to the clinical trial process. It might not be the factor most closely associated with clinical research but it is critical to the success of any trial.
It means that clinical investigation researchers not only have to be extremely well versed in their field but also have to have the ability to bring together all of the various elements of the trial within budget and on time. Because of the inherent complexity of clinical trials the expense of running them is substantial. Any oversight that causes a trial to go over its budget or beyond its deadline can quickly derail the entire process of bringing the drug or medical device to market.