SAFETY TESTING
SafeMark’s unmatched approach to safety testing follows three simple and sequential steps, resulting in a transparent, efficient, and comprehensive process.
- Initial Brand Name Review (PreMark)
Before launching straight into full safety testing we analyze and assess name candidates through PreMark. This step consists of a set of 27 unduplicated questions based on regional regulatory guidance documentation to assess word construction, sound-alike/look-alike conflicts, promotional claims, and elements of confusion. This data is used alongside an in-depth POCA evaluation to ensure that our clients have the upmost confidence in the list of name candidates prior to moving into full safety testing and simulation.
- Prescription Simulation Study (RxSim)
Many regional regulatory authorities – including the FDA, EMA, and Health Canada – address prescription simulation in their guidance. RxSim emulates real-life prescription orders through the collection and interpretation of handwritten, verbal, and electronic orders amongst validated healthcare professionals tailored to the product’s specific prescribing environment to test for likelihood of confusion.
- Safety & Commercial Evaluation (ProMark)
ProMark provides comprehensive safety testing and evaluation of likelihood of confusion and associated risk for those regions that do not require prescription simulation testing, including Japan, Latin America, South Korea, and others. ProMark is conducted amongst validated healthcare professionals for thorough evaluation that goes beyond industry standard and may be expanded to include patients for commercial evaluation.
Why settle for just a single study with limited questions when you can ask more, get better data, and make the best decisions. Ask us about our commercial metrics and BrandScore!
