Good Clinical Practice – Results with Integrity
The Pharmatek team includes qualified and trained subject matter experts (SME) to deliver quality services and meet regulatory requirements.
Our highly competent team of specialist GCP auditors has conducted audits in a broad range of therapeutic areas in phases I through IV of clinical research according to international and national regulations and guidelines. Our SMEs are globally experienced and have executed audits across the world in the USA, EU, Canada, and Asia Pacific countries including Japan and Australia. Our Auditors are proficient in conducting both on-site and remote audits.
For each audit project, our team creates a customized audit strategy which outlines the process for planning, preparation, execution and reporting to fulfill our client’s needs. Each of our audit reports endure a peer review process to ensure the audit outcome meets each client’s high standards.
Our range of Clinical audit services include:
Investigator Site Audits
- Phase 1 to Phase IV
Vendor Audits
- Qualification
- Clinical Trail supply / Drug Depot
- Systems Supporting Clinical Studies
- Central Imaging Facility
- Contract Research Organizations
- Data Management
- Biostatistics
- Call Centers
Institutional Review Board (IRB) Audits
- Systems and Process
Central Lab Audits
- Sample Management
- Clinical Lab
Trail Master File Audits
- Manual and Electronic TMF
System / Process Audits
- Electronic submission audits
- Clinical operations and monitoring,
- Data entry and data management
- Statistical and Biostatistical department
- Medical writing department
Pharmatek GCP audits are customized for your specific project and budget needs. We can support all aspects of your projects, including audit plan development, audit scheduling, audit conduct, audit reporting, and audit follow-up services (e.g., review of audit responses). We conduct general qualification audits, program level audits, and study level audits.