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| Home > Services > Clinical Audit Services and Quality Assurance |
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- Periodic Internal audits conducted
- Custodian of SIROs SOPs across all functions
- Employees trained in ICH-GCP
Quality assurance for clinical studies the world over is a critical function. It takes on a greater level of
criticality when such studies are conducted in a distant country. SIRO’s QA Group has performed more than 140
internal audits and twenty third party audits. And the group is one of the key drivers that ensures SIRO's quality
matches the best globally. Very often Clients request the services of our QA group to audit their on going
clinical research programs across geographies.
Internal Quality Assurance
In keeping with the SIRO philosophy of continuous improvement, internal audits are conducted by its auditors to
ensure compliance to ICH GCP across all functions.
The SIRO CQA group is the custodian of the SIRO SOPs across all functions and is responsible for updating,
maintaining and ensuring adherence within the company.
At SIRO, the CQA group also functions as the initial training manager wherein all new employees are trained in
ICH-GCP by this group.
Contract Audit Services
SIRO can organize independent reviews and audits of clinical trial investigator sites, research groups, data
management audits and sponsor clinical operations, to ensure compliance with Good Clinical Practice (ICH-GCP),
FDA, and local regulatory standards as a part of clinical trial services.
Individual contracts for investigational sites, central laboratories and other CROs are also taken up by our
CQA group. The CQA group includes professionals with a background in clinical monitoring, auditing & development
and implementation of quality systems.
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