Working closely with our partners and co-operation with local laboratories enable us to support IVD Manufacturers with clinical performance study in Europe.
With long term experience in IVD industry, our experts will familiarize with your IVD device quickly and create a Clinical Performance Study Protocol/Plan (CPSP). Our team will follow up with the test laboratory during the study and update the procedure to ensure valid data to be produced by the study.
When clinical performance study is conducted, the data obtained is used in performance evaluation process and forms an important part of the clinical evidence.
Clinical Performance Study and/or Layman Study for:
• COVID-19 Test (Antigen/Neutralizing Antibody)
• Influenza A/B Test
• HIV Test
• Syphilis Test
• HCG Test / LH Test
• FOB Test
• Other IVD devices
Our team will:
• Develop Clinical Performance Study Protocol/Plan (CPSP) for your IVD device
• Seek regulatory approvals
• Carry out the literature search for you and help you make sure your documentation is clear and comprehensible.
• Set up and manage the clinical performance study
• Prepare clinical study reports and other necessary technical documentation for Notified Body conformity assessments.
• Review and, if requested, correct your files before submission.
Our experts will assist you with following aspects:
• Strategy development
• Determination of the state of the art
• Planning and conduct of the evaluations
• Scientific validity
• Analytical performance
• Clinical performance
• Planning and conduct of the PMPF activities and studies, and updating of the performance evaluation