My idea of “Service Level Agreement (SLA) in P Perspectiveharmacovigilance.” #pharmacovigilance #servicelevelagreement #sla #agreement START BY DEFINING METRICS The first conversation with a service provider should include a discussion of the metrics considered critical to the success of the outsourced program or service. These metrics should reflect your business needs, measure economically (p.B performance calculation) and report and be easy to understand. With regard to this last point, everyone should agree that what needs to be measured can be easily written. Everest Group proposes to follow the acronym SMART in the definition of performance metrics: in addition to the definition of expectations for FSPs (functional service providers), the use of SLAs (Services Level Agreements) in the pharmaceutical industry is not common, despite the tangible benefits of these documents. Essentially, ALS defines critical metrics and expectations for service, as well as incentives and deterrence to achieve/miss these measures and expectations. In the pharmacovigilance (PV) industry, pharmacovigilance service providers and pharmaceutical companies (clients) come together for a variety of PV-related activities. This may be an individual PV activity or end-to-end photovoltaic activities on behalf of the customer. Many parties can participate in the conduct and conduct of a clinical trial and it is important that each party has a clear reference to what is expected of it. AVOID COMMON PITFALLS If you define what is acceptable with regard to your ALS, beware of traps as you can expect from your service provider more than you can expect from your own staff or go for perfection. While these may be valid objectives, you need to consider the costs of each position. For example, if your in-house team indicates that it is important for them to check the final monitoring reports within five business days of the visit, this may not be the SOP timeline for the service provider. Therefore, your in-house team needs to define the appropriate expected service levels and see how those expectations are compatible with the service provider`s capabilities.
At the site level, the roles and responsibilities of the Chief Investigator should be documented and agreed upon, particularly when it comes to delegated sponsorship missions (see sponsorship). Service Level Agreements (ALS) are generally a mutual commitment between the service provider and a customer. KPIs do not have financial loans, but they are important as early warning indicators for problems related to the implementation of CPIs. KPIs and CPIs may be “encouraged” and/or “degraded” at the sponsor`s discretion after 60 days in advance. The agreement may also offer a bonus for early completion of milestones, but does not offer bonuses for exceeding performance levels. In addition, it should be noted that the bonus does not correspond to the potential fine that the CRO may accumulate. In the end, you need to gain confidence to implement this type of agreement. To do this, regular meetings on governance and, if necessary, ad hoc discussions.