Outsourcing Pharmacovigilance for SME Companies
There have been significant developments in the pharmacovigilance sector since the start of the 21st century. Keeping up with the changes can often be a problem for small and medium-sized companies (SME’s). Many of these SME companies consider outsourcing pharmacovigilance to ensure that their PV needs are met in a professional, comprehensive and cost-effective means.
PV outsourcing delegates the implementation of drug safety functions and processes to a third-party provider. This transfer provides a flexible solution to the ever-changing demands of running a specialist pharmacovigilance team for SME’s.
Tasks that could usually be performed in-house are contracted to a dedicated service provider, whether it is on a full service, partial or project basis. Outsourcing for SMEs is a very attractive option as it allows them to begin activities immediately, without the need to set up a pharmacovigilance department or invest in the significant upfront cost of a pharmacovigilance database.
PV requires meticulous attention to detail and consistency. It is a high-pressure environment that requires expertise to identify new hazards to patients and prevent triggering false signals. The emergence of digital health, internet, and new regulations has resulted in high volume, low-quality information that is often incomplete. This information is collected from multiple, diverse sources. By outsourcing this task to an experienced partner, the SME can facilitate the full assessment of the drug’s benefit-risk profile and allow the SME to focus on other demands.
Unpredictable workloads can be a common occurrence in PV. This means companies must be prepared to handle these fluctuations. By outsourcing, SMEs have convenient access to a broader pool of specialised staff that can manage these increases in the workloads. Aggregate safety reporting, benefit-risk evaluation, signal detection, and the development of risk management plans are also becoming increasingly complex and resource-intensive. Outsourcing these responsibilities, small and medium-sized companies can balance their workload. Along with the main PV activities, other PV related activities are can also be outsourced which include electronic Common Technical Documents (eCTDs), Standard Operating Procedures (SOPs), inspection readiness and audit preparation.
We Can Help
The outsourcing of the pharmacovigilance task provides a flexible approach to the ever-changing demands of running a specialist team. Duties that would usually be performed in-house can be contacted either on a full service, partial or project basis. We can assist you with any issues relating to your pharmacovigilance needs. Contact us on 00353 52 61 76 706 or complete the form below and we will get back to you.