When a pharmaceutical organization is granted a license to release a drug to the market, it is granted on the back of various phases of clinical trials where the drug will have been tested firstly on healthy volunteers and then on patients going through from the condition that the drug is designed to treat. In various cases, the drug will be tested for a broad period of time on 1000s of people the intention being that as many of the adverse effects of the drug will have been seen during the clinical trials.
The licensing authorities will be a balanced act – on the one hand medicines should be safe as possible and they need to ensure that diseases are treated. In order to help attain this balance there are methods in place to make sure safety once a drug is on the market.
In order to almost guarantee finding a side effect that happens in one in ten patients, you have to offer the drug to thirty patients just to make sure of finding that effect. Pharmacovigilance is a science of drug safety, a blend of Pharmacoepidemiology and Pharmacology it offers the tools to help assess risk Vs benefit, to detect signals in data that point to an adverse event and to help assess the signal significance.
These services are an area that obviously no pharmaceutical company can afford to make a single mistake with. It can be time consuming task to decipher all the details from prospective pharmacovigilance companies, costing you valuable working hours.
Pharmacovigilance solutions providers must be able to provide you complete services during the pre-marketing and post – marketing phases for every product. This simple rule can avoid having to waste time and also substantial amount of the budget handling over the new pharmacovigilance companies at various stages of a product life cycle.
It goes without saying that clinical trials can be performed successfully if the pharmacovigilance solutions provider can ensure the clinical trial safety data has been managed well. The query arises over whether the provider might be able to provide service throughout the trial programme, not just one trial or trial stage.