| Pharmacovigilance services are an area that obviously | | | | expertly handle managing clinical trial suspected |
| no pharmaceutical company can afford to make a | | | | adverse events (SAE) from the micro level of case |
| single mistake with. It can be a time-draining task to | | | | assessment to the macro level of actually facilitating |
| decipher all the information from prospective | | | | expedited reporting of SUSARs (Suspected |
| pharmacovigilance companies, costing you valuable | | | | Unexpected Serious Adverse Reactions) to the |
| working hours. This article therefore gives a simple | | | | regulatory authorities in your location. Then the |
| perspective on the overall operational requirements | | | | requirement for Annual Safety Reports (ASRs) will be |
| providers should offer, which could more efficiently | | | | a budgeting consideration throughout the clinical trial |
| streamline the entire process at both pre and post | | | | programme. Using the same pharmacovigilance |
| marketing authority levels. By spending ten minutes | | | | services company obviously streamlines operations in |
| reading this, you can come away with a basic | | | | this respect. And the same company should be able |
| checklist from which to start researching potential | | | | to provide a data safety monitoring board should one |
| pharmacovigilance solutions providerswith more | | | | be necessary. |
| informed insight and direction. | | | | Having met the stringent regulatory requirements |
| Pharmacovigilance solutions providers should be able | | | | during the trial phase, it makes sense to use a |
| to offer you comprehensive servicesduring the pre | | | | company which is able to competently manage things |
| marketing and post marketing phases for each | | | | after the product is granted a marketing |
| product. This simple 'rule' can avoid having to waste | | | | authorisation. On an ongoing basis, it could be argued |
| time and potentially substantial amounts of the | | | | it is better to avoid the need to distribute the work |
| budget handing over to new pharmacovigilance | | | | among differing pharmacovigilance companies, if |
| companies at different stages in the product life | | | | nothing else from an administrative point of view. |
| cycle. | | | | Case processing, expedited reporting and periodic |
| It goes without saying that clinical trials can only be | | | | safety update reports (PSURs) can all in fact be |
| successfully conducted if the pharmacovigilance | | | | handled by one provider, alongside literature screening |
| solutions provider can adequately ensure the clinical | | | | and safety signal detection and review. The |
| trial safety data has been properly managed. The | | | | advantage of working with the one provider are |
| question arises over whether your provider can offer | | | | going to be manifold here - your staff will become |
| a complete service throughout the trial programme, | | | | familiar with the company's staff, administration time |
| not just one trial or trial stage. If not, elements would | | | | may be saved and certainly would be by avoiding the |
| have to be outsourced again, bringing you back to | | | | need to keep repeating the task of find a new |
| the start again in locating a suitable provider. There | | | | pharmacovigilance services firm to outsource to. |
| needs to be substantial experience and capacity to | | | | |