Pharmacovigilance (PV) and medical information (MI) services are an important requirement for every life sciences firm, yet there are significant challenges when it comes to combining global efficiencies with local requirements. There are significant time, costs, privacy regulations and language requirements that must be considered.  In many cases, dedicated PV teams are required in individual countries to translate adverse events (AEs) and MI documents, prepare files for centralised case processing, literature review, regulatory reporting and acting as a local qualified person responsible for pharmacovigilance (QPPV).

For global life sciences companies, managing these operations at the country level can cost millions, with close to half of the budget spent on manual data entry and tasks that don’t properly leverage the full talents of the local team. It’s been found that results are patchy where there are high rates of error from varied processes and uneven oversight at the local level by affiliates and different vendors. This leads to inaccurate documentation across regions and many management challenges related to bringing together all the information in a global manner.

An integrated approach to global and local PV and MI is needed to streamline operations and ensure a comprehensive view of information to enhance patient safety overall. It is critical to maintain consistency and transparency between local and global outfits, particularly when it comes to training and documentation. So how does one ensure these processes run efficiently and compliantly while still managing to reduce costs?

When life sciences companies pair local PV offices with above-country support teams, it streamlines operations, lowers costs and improves data consistency. These dedicated above-country teams provide the guidance and ability to act as a conduit between local and global PV teams to ensure regulatory compliance is met at all levels. In many cases these teams are in communities that have the necessary language skills and training needed for the region.

However, there are countries where specific language requirements and regulations require onsite PV teams. In this case, many individuals are trained to address multiple functions so that all resources are wisely employed. These individuals can provide direct translation and information redaction, and can review tasks related to MI services and local AE intake before they are sent to central case processing through the above-country teams. They can also act as local QPPVs to fulfil that necessary regulatory requirement.

These regional-based groups act as hubs for PV and MI teams, delivering significant benefits that include accelerated AE intake, greater communications, consistency and visibility.

Costs drop significantly with this centralised hub model. Part of this is due to the reduction in highly repetitive tasks while increasing the ability to bring greater transparency and efficiency in processing information more quickly. As AEs are sent to central case processing more quickly, firms can uncover trends that enhance patient safety.

Additionally, local teams have a more reliable support system that is critical when new products are launched or when seasonal demands cause a spike in MI requests or AE intakes. This support mitigates the impact of turnover in these local teams.

There are plenty of innovations that can help bolster smooth collaboration between the global and local levels, ensure consistency across affiliates, increase cost savings, improve patient safety and alleviate high-volume strain on local PV teams.

By bringing together local and global PV efforts with the middle layer of the above-country teams, life sciences firms are able to transform activities while securing new insights from the consistency of data collection. IQVIA’s Local Affiliate Product Services (LAPS) solution, already in use by several large firms, is providing this support successfully, allowing for greater efficiency for local PV, MI and risk management.

For instance, IQVIA has regionals hubs in Europe, the Americas, Asia-Pacific, the Middle East and Africa, with more than 350 full-time staff who act as regional hubs for several large life sciences firms. With the teams fluent in more than 50 languages, clients estimate that working with the IQVIA hub model is providing close to 45% cost savings for PV and MI activities. In addition, it is improving quality, consistency of information and activities and greater access to PV trend data.

For more information, visit www.iqvia.com/globalcompliance. or download the fact sheet at www.iqvia.com/library/fact-sheets/local-affiliate-product-services.