The previous blog post discussed the benefits and required features of the safety database. With increasing incidence of adverse event reports, new novel medicines and the presence of more stringent regulatory frameworks for drug safety have impacted the need to outsource the pharmacovigilance tasks. The Dutch Health and Youth Care Inspectorate (IGJ) published in July 2024 that 75% of marketing authorisation holders (MAHs) in the Netherlands are outsourcing their case processing and 82% their database maintenance.
Benefits of outsourcing adverse event processing
Database selection, validation and implementation is time consuming and requires cross functional expertise. Recruitment, training and maintenance of in-house personal is resource heavy, but can be mitigated via outsourcing a ready-to-use system with access to specialist knowledge and expertise. In the end, you may significantly reduce costs associated with developing and maintaining an in-house system.
The MAH must ensure that critical pharmacovigilance activities can be undertaken continuously, meaning accounting for business continuity risk. With outsourcing, you have access to continuously trained personnel who are routinely performing tasks related to the safety database and Individual Case Safety Report (ICSR) processing. This can lead to more efficient and accurate safety data management. Experts specialising in pharmacovigilance can provide valuable recommendations for improving safety processes in your company. The number of the received adverse event reports may vary, for example due to ongoing post-market surveillance studies or clinical trials. Using vendors allows for scalability in resources.
Legislative changes are continuous and without resources in your company having time enough to track all changes, understand the implications to your business and keep the system up-to-date with the latest regulatory requirements you risk falling foul of changes. Vendors will follow these changes and inform you before they happen. Also, the risk of compliance on fulfilling timelines on submission deadlines of ICSRs to the regulatory authorities is smaller when there are enough experts to handle cases.
By well-planned and organised outsourcing of one or more pharmacovigilance tasks you can focus on what you do so company efficiency may be added.
Considerations in outsourcing adverse event processing
Outsourcing of Individual Case Safety Report (ICSR) processing offers many benefits, but it also comes with challenges. Here is a closer look at some of the key cons and how to avoid them.
Losing control of your data
Smooth and transparent co-operation with the service provider. Clear communication and coordination between your selected vendor and the in-house team are essential to ensure that all safety data is accurately captured and processed, and that oversight is maintained to mitigate risks. You also should have an overlook of the activities and safety data.
Communication challenges
Time zones, languages and cultural practices; these can potentially affect the efficiency and accuracy of case processing. Therefore, when selecting a vendor, routine communication should be maintained.
Data quality and consistency
When outsourcing ICSR processing, you must ensure that the data collected from various sources is com-plete and accurate. This involves standardisation of data entry and coding practices and conducting rigorous quality checks to ensure data integrity.
Regulatory compliance
Pharmaceutical companies must comply with diverse regulatory requirements across different countries and navigating the complex and varying regulatory requirements across different countries can be challenging. If the vendor fails to adhere to regulations, it can result in non-compliance, legal penalties and damage to the company’s reputation. It is necessary to perform regular audits and compliance checks over your vendor to ensure adherence.
In addition, data protection regulations like GDPR must be complied with to protect sensitive personal data. Requiring robust security measures from the vendor helps to protect sensitive data.
Product knowledge
There can also be doubt whether the vendor’s employees know your product and is therefore able to handle the data appropriately. This can be avoided with a strong kick-off meeting, SPC/IB training and informing the vendor of product information updates.
Choosing the right vendor for ICSR handling
While outsourcing ICSR processing offers numerous benefits, it also presents several challenges that need to be carefully managed. By addressing these challenges through strategic planning, selecting the right vendor, and implementing a robust connection between your company and vendor, you can ensure efficient and compliant ICSR processing. To mitigate these risks, it’s essential to conduct thorough due diligence when selecting a provider, establish clear contracts and implement regular monitoring, audits and communication lines.
Prioritise the company that you see will take your company and your products seriously. With experienced personnel, readily validated systems, and infrastructure, the company can save on their own pharmacovigilance, quality, and IT resources – not forgetting the server costs. The company’s own employees’ time can be used on management, data analysis, and oversight of the system rather than setting up a database from scratch and learning to use it for everyday tasks.
Medfiles provides comprehensive GVP-compliant pharmacovigilance services including case processing and safety database services. Together we can guarantee your product safety profile is known and well managed.
Author: Satu Kujala, Head of Pharmacovigilance
Satu Kujala has worked at Medfiles since 1999 acting in various leadership positions. She is currently serving as Head of the Pharmacovigilance team consisting of 20 experts in Finland and Baltics.
Satu has a Licentiate’s degree in Philosophy (pharmacy), and she has specialised in pharmacology and industrial pharmacy. She graduated from the University of Helsinki. After a short career in the university and pharmacy, she has worked within the pharmaceutical industry for 30 years and has gained diverse experience through working on marketing, quality, wholesale, clinical trials, safety and regulatory tasks. She is familiar with Good Clinical, Pharmacovigilance and Distribution Practices (GCP, GVP and GDP). Acting as EU QPPV for sixteen years has given her deep knowledge and experience of pharmacovigilance systems.
Author: Veera Kumpulainen, Safety Manager
Veera Kumpulainen works as a Safety Manager in the Pharmacovigilance Unit at Medfiles. Veera joined Medfiles in 2020 as a Drug Safety Expert and her responsibilities have included a variety of safety related tasks.
Veera holds a Master’s in Molecular Medicine and Cancer Research and a Bachelor’s in Biomedical Science from Brunel University of London. Prior to Medfiles, Veera gained experience in the Global Patient Safety department of a Big 5 Pharma in the UK. She has extensive case processing experience in range of therapeutic areas, with a primary focus on oncology. She currently acts as the Medfiles dQPPV and is involved in the oversight and training of the ICSR case processing team.
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