Clinical Performance Studies

Clinical performance studies aim to demonstrate or confirm the safety and performance of a product. Under the IVDR, such studies may only be omitted if adequate clinical and analytical performance data already exist, or if the product does not have a defined clinical performance.

For novel markers or technologies, a clinical performance study is typically required prior to the declaration of conformity. Even for established products, a clinical performance study in the form of a PMPF study may also be needed under the IVDR to fill any gaps in clinical evidence.

novineon CRO ensures regulatory compliance at every step and supports you through each phase of your performance study:

• Planning and execution of clinical performance studies in line with IVDR and ISO 20916
• Recruitment of suitable study centers / acquisition of sample material
• Project management, study monitoring, data management, and statistical analysis