Evaluation and demonstration of product safety 

for medicinal products & medical devices

Clinical evaluations and investigations are an effective tool in obtaining key information on the performance of a medicinal product and medical device (particularly with regard to its safety, including interactions with other products). For both medicinal products and medical devices, we can prepare complete documentation required for submission to the SÚKL for NIS and PMCF. We also provide consultancy during the clinical evaluations/investigations, including support with the preparation of periodic reports as well as the final report.

In the field of clinical evaluations and investigations, we can:  

• Prepare an analysis of the available literature prior to the evaluation/investigation

• Assess an appropriate model and method for the evaluations/investigation process

• Prepare a protocol, documents for ethics committees approval, informed consent and other necessary documentation
• Provide and submit complete documentation for approval to SÚKL, report key data (beginning/end of the clinical investigation)
• Provide consultancy including preparation of documentation in case of deviations and changes during the evaluation/investigation
• Participate in monitoring, data collection&analysis
• Record and report adverse events during clinical evalutions
  
• Prepare interim and final reports

All documentation can be processed in Czech, Slovak or English according to your requirements.