Embracing Pharmacovigilance with Technology in Biopharmaceuticals



Pharma IQ
06/03/2010


It is relatively common knowledge that the pharmaceutical industry must meet a range of guidelines as it works to ensure the safety and effectiveness of the products it develops. However, what is perhaps less known is how such work continues 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 medicines to identify previously unacknowledged adverse effects or a change in patterns, and the assessment of the risks and benefits of drugs to determine how they can
be improved. It can also involve the distribution of information to encourage the safe and effective use of medicines, alongside examination of the impact of such actions.

Many companies in the pharmaceutical world have provisions in place to deal with pharmacovigilance and other so-called late phase issues, as they realise the important role they can play in boosting the market penetration of products and – perhaps more importantly – improving support for the patients that demand them. A number of firms involved in contract research have also chosen to provide such services to smaller and mid-sized companies which lack the resources to carry out such work on their own.

Parexel is an example of such an organisation, with its Peri Approval Clinical Excellence (PACE) service designed to offer clients the chance to migrate "from product development to commercialisation in a seamless and cost-effective manner".

The company announced the launch of a new web-based technology platform designed specifically to boost efficiency and meet the regulatory needs that exist in relation to pharmacovigilance in the biopharmaceutical industry. Based on the strategies and processes of its PACE team, the new system integrates such
information with e-clinical solutions provided by its technology subsidiary Perceptive Informatics.

Dr Carol Collins, corporate vice-president and worldwide head of PACE, said the need 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 in managing the high volume throughput of data while controlling the costs related to these programs," she explained. "We are focused on helping clients achieve greater efficiency by gathering more data at a significantly lower cost per patient."

The new system includes a range of features and benefits designed to boost efficiency, such as a streamlined user experience with single access and anintuitive interface with functionality for site self-registration and management. In addition, users have access to automated cues for late phase site requirements and enhanced reporting capabilities including investigator payment status reports.

Dr Collins suggested that such features would prove highly popular with users as they aim to ensure their drugs are performing to their potential in the market. "A variety of late phase studies, including observational studies and patient registries, are being used as either primary or adjunct vehicles for pharmacovigilance and health evaluation activities in order to meet increasing regulatory and payer demands for long-term safety and health outcomes data," she outlined.

"This new technology platform reinforces our commitment to assist clients in generating more robust product safety and heath outcomes profiles." With the concept of pharmacovigilance increasingly becoming a fundamental aspect of biopharmaceuticals, it is likely that Parexel's new solution will be the first of many designed to meld proven processes with the growing trend for systems to be based online. After all, technology has had a major impact across the entire pharmaceutical sector, so it only seems fair that this area should also
be affected.

However, such innovations will only act as aids during the process of drug development, meaning companies need to ensure they are fully prepared when approaching pharmacovigilance. One wrong turn on such strategies could not only lead to products being removed from the market, but could also cause permanent
damage to a firm's reputation.