• After analyzing the costs, the resources demanded, such as staff, equipment, and facilities are more expensive than outsourcing.
  • The skillset necessary (clinical, scientific, customer service, etc.) is not available in-house or recruitable in the necessary timeframe.
  • Appropriate work procedures, tracking systems, training programs and/or auditing processes are not in place.
  • The schedule for getting the service up to speed does not allow enough time to create a quality program.
  • Based on workloads and the level of service demanded, in-house workers would be inefficiently idle.
  • The department has a temporary staffing deficit due to illness, maternity leave, etc.
  • You or your team are unfamiliar with the regulations, both existing and emerging. This is particularly relevant when expanding product distribution internationally.
  • The risks of sourcing PV and MI services in-house are too high, potentially leaving the company exposed.
  • Key points in the product lifecycle demand either high activity (such as at the start of a clinical trial) or low activity (during the end of the product lifecycle).

Keep in mind that outsourcing is not “out-of-mind sourcing”. Regardless of whether you manage your PV and MI program or outsource, you as the product owner or sponsor are responsible for the safety surveillance process and the outcomes.