Conduct of Phase-I/BA/BE clinical study is a strategic alliance between a contract research organization (CRO) and a pharmaceutical company. Pharmaceutical companies face lot of issues from selecting inefficient CROs leading to inevitable repercussions. Selecting such CROs gives uncertainty in approval of the product by regulatory authorities which ultimately leads to devastating business in the pharma market. To gain competitive advantage in drug discovery and clinical research, selecting suitable CRO has become more challenging for most of the pharmaceutical and biotech companies.
System and Facility Audit for CROs
The CliniApps Advantage
CliniApps assists in selecting the CRO and qualifying them by conducting System and Facility audits with well experienced professionals from regulatory environment. Our Inspectors evaluate and qualify the site for quality compliance, adherence to the procedures, sponsor obligations and breach of regulations. Under qualification audit we cover all the divisions of organisation for approval and authorization of Clinical and Bioanalytical project management.
What Qualification Audits include?
Management and Operations strategy
Regulatory approvals and refusals
Clinical facility
Bioanalytical laboratory
Quality assurance
PK and Statistics
Quality control
Information technology
Archival facility
Sample storage facility
Administration and Maintenance
Supply chain management
What Qualification audits in other areas include?
Vendor qualification (Service providers)
Pre inspection audits
GCLP mock audits
Site specific audits
Annual quality assurance audits
Deliverables
Monitoring Agenda and Monitoring Plan
All the communications with the CRO
Monitoring observations and complete monitoring report
CAPA and Reponses to the report.
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