Clinical studies are becoming more complex and the regulatory expectations in terms of quality and compliance for clinical trials and pharmacovigilance are increasing while companies are also trying to drive down costs. A solution widely used is the outsourcing or offshoring of activities.
Outsourcing is at times limited to individual tasks but may include entire operations. Outsourcing decisions are not static and in large organisations in – and outsourced activities for the same service or product may coexist. This results in less direct control and, if processes are not designed to support this, to a loss of oversight, which can lead to regulatory non-compliance and material damage. The first step to undertake is the qualification of the vendor(s). The second step, once it is decided to transfer tasks to service providers, is to adapt the internal processes to a different business process model to ensure the appropriate level of oversight.
How can Widler & Schiemann assist with your Vendor Qualification & Assessments?
Both partners have extensive experience in qualifying vendors and designing processes ranging from pre-contract assessments (risk based) to in-process audits and quality risk assessments. In addition, Widler & Schiemann have comprehensive experience setting up a systematic assessment of vendors and in-process control of its quality related performance. Widler & Schiemann will work with your experts and process owners to establish a standardised approach to vendor qualification and assessment based on QRM methodology developing or using your existing key performance parameters and business priorities.
