Pharmacovigilance and Outsourcing Case Study – Utilizing a Fully Outsourced Model for Case Processing

United Therapeutics has undertaken a fully outsourced model for case processing. Maintaining the efficiencies the model was expected to provide requires establishing a functional integration of the vendor into the global pharmacovigilance system, and effective management of the relationship. In this interview Dr. Anthony Lassiter, Head of Global Drug Safety at United Therapeutics, joins Pharma IQ to give an overview and analysis of their model.

Pharma IQ: Establishing a functional integration of the vendor into the global pharmacovigilance system is crucial to the success of an outsourced model for case
processing. How did you do this?

Dr. Anthony Lassiter:
Considerable forethought must be given to which aspect(s) of the
pharmacovigilance system one wishes to outsource and why. Once the parameters and goals are established, the next step is to create a compartment in which the outsourced function will occupy and the interfaces to the compartment. My preference was to make the presence of a vendor as transparent to the internal and external organization as possible. We did this by making no external changes to the inboxes and outboxes with which our customers were already comfortable. Second was a communication plan introducing the new functional model and the rationale for the change. Expectations are managed up front minimizing confusion at the changeover.

Pharma IQ: What can  you recommend as far as effective management of the relationship with the vendor?

Dr. Anthony Lassiter: A good start is to create a table listing all the functions and
responsibilities to be addressed followed by one column each for the sponsor and vendor. If there is more than one “x” per row in this table, you have not sufficiently though out the activity. This may seem a trivial exercise but without it, there is potential for constant fingerpointing wherever there is overlap. The sponsor is ultimately responsible for assuring that all vendor functions are executed to specification. Two levels of oversight meetings are necessary: an operational meeting where implantation issues are discussed and an executive oversight meeting where strategic and quality issues are resolved. The regulatory environment is not static thus the functional relationship will evolve over time.

Pharma IQ:
How do you ensure quality integration?

Dr. Anthony Lassiter:
Once the vendor’s operational plan was reviewed and approved, a
quality plan was build around it. The quality plan was designed to 1) review the “product” of the operational plan against the sponsor specifications and 2) track metrics and compliance.

Pharma IQ: What about managing processes and communication, what have you found to be effective?

Dr. Anthony Lassiter: As introduced above, there needs to be operational and strategic
planning and oversight. Likewise, communication was structured to follow this model. Apart from the formal communication at meeting, ad hoc issue driven communication in both directions should be encouraged. In a true partnership, feedback is valued in both directions. Partnering with an experienced CRO affords valuable “best practices” insights. Ignoring this often wastes a resource.

Pharma IQ:
What challenges have you faced?

Dr. Anthony Lassiter:
The first big decision is often whether to use sponsor or vendor
processes or a hybrid containing some of both. The hybrid approach for us proved to be the least workable. The challenge came in re-casting the relationship to solve these issues.

Pharma IQ: All in all, what is your evaluation of this model?

Dr. Anthony Lassiter:
For our organization, this was the best choice for the problem we needed to solve. In one form or another, outsourcing is the only scalable option for many organizations. There is a clear spectrum of available models. At one end, the vendor is a service agent and fully autonomous. We are at the other end where the vendor is functionally integrated into our global pharmacovigilance system. Large and small companies have the same options available to them depending on how they choose to view the problem to be solved. Our model carries the advantage, in my opinion, of deriving the full value of vendor expertise in executing our safety operations. We gain both service and knowledge in this model.

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