From Early Feasibility and First-In-Man Studies to Post Market Clinical Follow-Up (PMCF) Studies, we specialize in providing comprehensive support. Our Clinical Operations team is highly skilled and experienced in project management, site management, monitoring, and safety management. Furthermore, our multi-lingual clinical staff trained in ICH GCP and EN ISO 14155 are based all across the EU. We have a proven track record of successful audits by FDA and various EU Member State Competent Authorities.
From regulatory submissions to site close-out we process in full compliance with EN ISO 14155, EN ISO 13485, 21 CFR Part 820 which include :
- Site Selection and Qualification.
- Site Initiation (SIVs) and Support Visits/Staff Training.
- Site Management and Monitoring by local MedPass CRAs with native language ability.
- Clinical Project Management.
- Safety Management and Reporting.
- CEC/DSMB Set-up and management.
- Writing of Clinical Study Reports.
MedPass can also manage other specialist groups such as Core Labs and CROs outside of the EU including but not limited to the US, Australia and New Zealand.