06/20/2018 updated
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GCP Consultant / GCP Auditors / GCP Audits / Pharmacovigilance Audits / GLP / GMP Audits
India
India
AuditingBiostatisticsClinical Data ManagementClinical TrialsDatabasesContract ManagementData ManagementPharmacovigilanceLanguage TranslationMarketing Co-OperationsPeriodic Safety Update Report
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
Languages
EnglishNative speaker