Clinical Trial Activities including:
EudraCT number, IRB/EC submission, CTA submission, Collection and maintenance of required essential documents, Informed Consent Form (ICF) and Patient Information Form review, Trial protocol planning, Trial Master File (TMF) support, CT results disclosure in public registries (EU CTR, CT.gov, EU PAS), Archiving.
Quality Assurance Activities including:
QMS audits, Trial monitoring, Internal systems audits, TMF audits, Vendor qualification audits, Supplier qualification audits, Investigative site audits, Regulatory document audits, GMP audits (pharmaceuticals, food ingredients), Food safety audits (FSSC 22000).
- Trial staff training
- Internal GCP training
- Internal QMS training