A close collaboration of scientific writers and biostatisticians to design your research project and communicate…
A wide range of safety services for your clinical research projects
OUR VIGILANCE EXPERTS WILL PROVIDE YOU
WITH THE BEST SUPPORT
A thorough collection and evaluation of product safety information is critical to the success of clinical research. Our vigilance experts will support you to define the best suited vigilance process to follow according to the specificities of your project and the applicable regulatory environment.
Our vigilance team, made up of doctors of pharmacy who have access to medical support as needed, provide full support for Drugs, Advanced Therapy Medicinal Products (ATMP) and Medical Device vigilance activities including:
- Management of vigilance activities during clinical trials, clinical investigations or other interventional studies
- Design / Consulting / Review of the Safety documentation: protocol, SAE Forms, safety management plans, clinical study reports, etc…
- Registration of IMP(s) in the eXtended EudraVigilance Medicinal Products Dictionary (XEVMPD)
- Adverse Events (AEs) and Serious Adverse Events (SAEs) management including case review, data entry and narrative writing in a safety database, CIOMs/MedWatch and line-listing edition
- SAEs reconciliation with the clinical database
- Expedited reporting of SUSARs or other reportable events to EudraVigilance, the national Competent Authorities and the Ethics Committees (as applicable)
- Writing of Annual Safety Reports / DSUR / Vigilance Reports and transmission to the Regulatory Authorities
Our safety database (Safety Easy®) is fully compliant with the European and ICH E2B requirements and includes a MedDRA dictionary tool. This database enables the ICSR export as XML files in ICH E2B format suitable for electronic transmission to the EudraVigilance database.