Safety and CEC Management
Safety evaluation standards in the medical device world are progressively getting closer to those applicable to biopharmaceutical products.
Thanks to our global knowledge and wide experience in pharmaco- and device vigilance, ClinSearch can bring different services to companies by applying internal procedures in accordance with the European and International legislation and guidelines.
Our services include:
- Safety Management plan writing;
- Incident/Serious adverse event (SAE, SUSAR/USADE) reporting assistance;
- Narrative writing ;
- Writing of initial, follow-up and final SAE reports;
- Reporting to the authorities;
- CEC management including CEC charter writing;
- Writing of periodic safety summary and trend reports.
Our monitors are well trained for reviewing and processing the events/incidents during the duration of the study.
ClinSearch can also manage the CEC by selecting the experts and dealing with their agreement. This committee, in charge of the analysis of Adverse Events, will have an independent review of the events with a direct access to additional supportive documentation, such as hospital reports, laboratory results, images, etc. Adjudication could be carried out in a meeting or remotely. Adjudication results are collected directly on the EDClinTM, which has integrated a solution to upload imaging (DICOM files) and documents.