A Clinical Evaluation Report (CER) documents the conclusions of the clinical evaluation of a medical device at a certain time. It consists of analyzed clinical data from previous studies and publications and demonstrates that this device achieves its intended purpose and that the balance benefit/risk is positive. Regular updates to CERs are required as part of the post-market surveillance to document any changes that may impact previous conclusions.
Medical and regulatory documentation developed by experienced medical writers plays a pivotal role in the success of a clinical research project. Our medical writing team works closely with key operational departments including Biostatistics, Analytics, Medical Affairs, and Clinical Operations to produce comprehensive and fully integrated deliverables.
The Medical Device regulatory landscape is constantly evolving. This requires development of agile and innovative technologies. Through ELCEVAR MedTech, ECLEVAR is developing methods that semi-automate several steps of the CER pipeline via machine learning. We have developed state-of-the-art natural language processing (NLP) algorithms to drastically reduce the time and costs required to produce standard CERs while enhancing comprehensiveness and quality.
Our technology accelerates the work of medical writers and enables them to harness and focus their expertise and experience to produce high-quality standard CERs. Automation help them expedite most steps of the systematic review process including search, screening and data extraction.
A clinical evaluation shall follow a defined and methodologically sound procedure based on the following:
Preparing a new CEP and CER
Do you need help updating your CER with PMS and PMCF data?
Conducting a gap analysis of your existing CER aiginst MDR
To comply with the recent regulatory requirements
Training your staff on how to write, improve CER preparations or review
A literature review is a mandatory part of each Clinical Evaluation.