Which business model in a fast changing world for pharmacovigilance solutions?

Which Business Model in a Fast Changing World for Pharmacovigilance Solutions?

Pharmacovigilance (phv) departments are often characterized by dynamic processes since they play a vital role in managing a post market access product positioning.

Working in such a dynamic environment leads these teams to face a great number of challenges. In this blog post we will identify some of the main challenges faced by phv departments and understand how the decision to choose different business models can impact on phv teams’ processes and costs.

Which are 3 of the main challenges in phv?

1. Ensuring compliance with continuously evolving regulations

This year in particular, keeping an eye on regulatory authorities’ guidelines is more than necessary for phv departments. Beginning with EMA new pharmacovigilance regulations (2012 and following) and the adoption (FDA, PMDA, EMA) of the standard E2B (R3) HL7.

2. Guaranteeing high levels of data integrity

Data integrity can be defined as the act of maintaining and assuring the accuracy and the consistency of data in its entire lifecycle. In recent years, regulatory inspection (both FDA and EU) have reported significant increase in the number and type of data integrity issues

3. Maintaining efficient and cost effective operations

Operations have to focus on core pharmacovigilance services. Therefore, they need to involve and coordinate IT and CSV teams to support the phv system in order to meet business requirements and grant infrastructure availability and performances.

That said, which might be the business and organizational approaches that companies may adopt to manage in a flexible way the fast changing market dynamics?

   Company A: Phv Outsourced as a Full Service: 1 provider, 1 contract.

Company A decides that phv activities (case entry, quality control, medical review…) will be performed by the provider and that the Safety platform will be selected and directly owned by the provider itself according to the request of the client.

  • Single provider = limited effort for monitoring process status and performances
  • No upfront investments: opex vs capex
  • Defined costs as per use (i.e. number of cases)
  • Need of migration in case of change of the provider
  • Risk increased as the system provider is not directly monitored by the client (Computer System Validation)

This means that Company A will witness two possible costs peaks in the long run: the first one is the migration costs due to a service provider change, the second one is related to audit finding management due to lack of CSV control.



   COMPANY B: Phv and Technology Outsourced as 2 separate services: 2 providers, 2 contracts.

Company B follows a different approach: he will outsource phv activities to a provider while having another one to furnish a safety platform delivered as a Service

  • Independency of contracts management allowing customer to exit from an outsourcing model to an insourcing model separately (services vs platform)
  • No upfront Investments: opex vs capex
  • Defined costs as per use (i.e. number of cases).
  • Increase of risk as the system provider is not directly monitored by the Client
  • Need of migration in case of change of IT service provider

Threats faced by company B will again be related to audit and Computer System Validation accuracy that could cause an unpredicted cost peak.




 Company C: Phv Outsourced and Technology owned by the customer but hosted by the provider: 2 providers, 2 contracts

Company C decides to outsource phv activities as a service, while the IT platform will be his property but hosted by a third party (Technology provider)

  • Independency of contracts management allowing the customer to exit from an outsourcing model to an insourcing model separately (services vs platform)
  • Defined costs as per use (service) and flat for Technology;
  • No Need of migration in case of change of IT service provider.
  • Upfront investment (Capex)

The last scenario results extremely interesting: it is true that Company C will on one side, bare little higher upfront investments for the system implementation, but will, on the other side, manage a stable cost curve managing a relatively low business and p&l risk.

The business models evaluation phase is crucial since it will affect phv departments’ costs and activities not only in the short but especially in the medium-long term.

Arithmos expert IT consultants guide customers through the identification of the best solution for their pharmacovigilance needs supporting both decision makers and users along the evaluation and implementation of the possible solution.

To discover more about our services in Pharmacovigilance visit our ArgusBlueprint page or contact us at info@arithmostech.com.

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