It can be a time-draining task to decipher all the information from prospective pharmacovigilance companies, costing you valuable working hours. This article therefore gives a simple perspective on the overall operational requirements providers should offer, which could more efficiently streamline the entire process at both pre and post marketing authority levels. By spending ten minutes reading this, you can come away with a basic checklist from which to start researching potential pharmacovigilance solutions providerswith more informed insight and direction.
Pharmacovigilance solutions providersPharmacovigilance course should be able to offer you comprehensive servicesduring the pre marketing and post marketing phases for each product. This simple ‘rule’ can avoid having to waste time and potentially substantial amounts of the budget handing over to new pharmacovigilance companies at different stages in the product life cycle.
It goes without saying that clinical trials can only be successfully conducted if the pharmacovigilance solutions provider can adequately ensure the clinical trial safety data has been properly managed. The question arises over whether your provider can offer a complete service throughout the trial programme, not just one trial or trial stage. If not, elements would have to be outsourced again, bringing you back to the start again in locating a suitable provider. There needs to be substantial experience and capacity to expertly handle managing clinical trial suspected adverse events (SAE) from the micro level of case assessment to the macro level of actually facilitating expedited reporting of SUSARs (Suspected Unexpected Serious Adverse Reactions) to the regulatory authorities in your location. Then the requirement for Annual Safety Reports (ASRs) will be a budgeting consideration throughout the clinical trial programme. Using the same pharmacovigilance services company obviously streamlines operations in this respect. And the same company should be able to provide a data safety monitoring board should one be necessary.
Having met the stringent regulatory requirements during the trial phase, it makes sense to use a company which is able to competently manage things after the product is granted a marketing authorisation. On an ongoing basis, it could be argued it is better to avoid the need to distribute the work among differing pharmacovigilance companies, if nothing else from an administrative point of view. Case processing, expedited reporting and periodic safety update reports (PSURs) can all in fact be handled by one provider, alongside literature screening and safety signal detection and review. The advantage of working with the one provider are going to be manifold here – your staff will become familiar with the company’s staff, administration time may be saved and certainly would be by avoiding the need to keep repeating the task of find a new pharmacovigilance services firm to outsource to.