Keywords
Skills
www.crqa.in
?GCP AUDITS:
?GCP AUDITS:
?Investigator Sites, IRB/IEC, Document Audits, Vendor, CRO (Phase I and/or BA/BE units)
?For Cause Audits
?Vendor Audits:
?Contract Research Organization Audits
?Central Laboratory Audits
?Clinical Trial Supply Audits
?Independent Ethics Committee Audits
?
?Clinical Data Management & Biostatistics Audits
?GCP AUDITS:
?Investigator Sites, IRB/IEC, Document Audits, Vendor, CRO (Phase I and/or BA/BE units)
?For Cause Audits
?Vendor Audits:
?Contract Research Organization Audits
?Central Laboratory Audits
?Clinical Trial Supply Audits
?Independent Ethics Committee Audits
?
?Clinical Data Management & Biostatistics Audits
Phamacovigilance Audits
-Database Set-up Audits
-Data Management In-Trial Audits
-Database Lock Audits
-System
-Process Audits
-Biostatistics Audits
Mock Inspections
GMP Audits
GLP Audits
GCP Trainings
Phamacovigilance Audits
?Global Pharmacovigilance audit
?MAH audit
?QPPV audit
?Company affiliates audit
?Business partner/Marketing partner audit
?Vendor/Service provider audit (Literature search, Case processing Unit, Translations, Vendor (PSUR/PABER/RMP/ADCO, etc.)
?Inspection/audit readiness
The audit program is designed to cover various aspects of clinical data management activities:
- EDC AuditsThe audit program is designed to cover various aspects of clinical data management activities:
-Database Set-up Audits
-Data Management In-Trial Audits
-Database Lock Audits
-System
-Process Audits
-Biostatistics Audits
Mock Inspections
GMP Audits
GLP Audits
GCP Trainings
Project history
Strong GCP Audits experience with several global clients. References would be provided upon request.
Local Availability
Only available in these countries:
India
Auditors are availale for India, China, South East Asia
Other
Please refer to our website - www.crqa.in
