Embracing pharmacovigilance with technology


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Embracing pharmacovigilance with technology

  1. 1. Embracing pharmacovigilance with technologyIt is relatively common knowledge that the pharmaceutical industry must meet arange of guidelines as it works to ensure the safety and effectiveness of theproducts it develops. However, what is perhaps less known is how such workcontinues even after new drugs or medicines have reached the market.Pharmacovigilance is used to carry out such projects, but what does it entail?According to the Pharmaceutical Information & Pharmacovigilance Association,the concept is based around several areas - including the monitoring of medicinesto identify previously unacknowledged adverse effects or a change in patterns,and the assessment of the risks and benefits of drugs to determine how they canbe improved. It can also involve the distribution of information to encourage thesafe and effective use of medicines, alongside examination of the impact of suchactions.Many companies in the pharmaceutical world have provisions in place to deal withpharmacovigilance and other so-called late phase issues, as they realise theimportant role they can play in boosting the market penetration of products and –perhaps more importantly – improving support for the patients that demandthem. A number of firms involved in contract research have also chosen toprovide such services to smaller and mid-sized companies which lack theresources to carry out such work on their own.Parexel is an example of such an organisation, with its Peri Approval ClinicalExcellence (PACE) service designed to offer clients the chance to migrate "fromproduct development to commercialisation in a seamless and cost-effectivemanner".The company announced the launch of a new web-based technology platformdesigned specifically to boost efficiency and meet the regulatory needs that existin relation to pharmacovigilance in the biopharmaceutical industry. Based on thestrategies and processes of its PACE team, the new system integrates suchinformation with e-clinical solutions provided by its technology subsidiaryPerceptive Informatics.Dr Carol Collins, corporate vice-president and worldwide head of PACE, said theneed for such a new system was driven by the increasing size and complexity ofpost-approval studies in the sector."As a result, biopharmaceutical companies require much greater efficiency inmanaging the high volume throughput of data while controlling the costs relatedto these programs," she explained. "We are focused on helping clients achievegreater efficiency by gathering more data at a significantly lower cost perpatient."The new system includes a range of features and benefits designed to boostefficiency, such as a streamlined user experience with single access and anintuitive interface with functionality for site self-registration and management. Inaddition, users have access to automated cues for late phase site requirementsand enhanced reporting capabilities including investigator payment statusreports.Dr Collins suggested that such features would prove highly popular with users asthey aim to ensure their drugs are performing to their potential in the market."A variety of late phase studies, including observational studies and patientregistries, are being used as either primary or adjunct vehicles forpharmacovigilance and health evaluation activities in order to meet increasingregulatory and payer demands for long-term safety and health outcomes data,"she outlined."This new technology platform reinforces our commitment to assist clients ingenerating more robust product safety and heath outcomes profiles."With the concept of pharmacovigilance increasingly becoming a fundamentalaspect of biopharmaceuticals, it is likely that Parexels new solution will be thefirst of many designed to meld proven processes with the growing trend for
  2. 2. systems to be based online. After all, technology has had a major impact acrossthe entire pharmaceutical sector, so it only seems fair that this area should alsobe affected.However, such innovations will only act as aids during the process of drugdevelopment, meaning companies need to ensure they are fully prepared whenapproaching pharmacovigilance. One wrong turn on such strategies could not onlylead to products being removed from the market, but could also cause permanentdamage to a firms reputation.05/05/10DirectNewsFound this interesting?You may like to also have a look at Adverse Event Reporting - Online TrainingCourse