Pharmacovigilance Operational Design

SSI Strategy has expertise in design and management of a variety of robust systems, including safety systems and quality management systems.  The same skills we employ during the process of analyzing safety systems in order to identify potential failure points are used during the design phase.  We build systems to meet the needs of the overall organization, the product portfolio, and the safety organization.

System design is not typically undertaken from a blank slate although we enjoy that the most.  We know that the best fit and most operationally efficient and effective systems are those that are build to purpose and incorporate the ability to capture metrics and flex as necessary.

SSI Strategy can work with your company to design a safety system from the ground up if appropriate, or can use the results of a diagnostic to redesign elements of the system.  We incorporate such methodologies as our proprietary 6-T Model^TM or Failure Mode and Effects Analysis to ensure the high quality of the system.