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Independent Monitoring/ Auditing

Six Sigma Bio is capable of monitoring complete clinical phase of the study at multiple locations across India

We provide Monitoring Visit report within 24 hours after each monitoring visit

Six Sigma Bio also assists sponsors in selecting the suitable BA/BE facility to conduct their study

Our Monitoring/Audit services include:

Clinical Study Monitoring:

In process monitoring

Retrospective review of raw data

Pk time points deviation review

Clinical/ integrated (clinical+pk) report review

Bioanalytical study monitoring:

Method Development (MD)/Method validation (MV) data review

Method Validation Report (MVR) review

Method SOP review

In Process Monitoring

Retrospective Monitoring

Bioanalytical Report review

Electronic Site Master file review and Verification of EDC

GCP, GLP and feasibility Audits

Medical Writing and
Scientific Communications
Clinical Trial Management
Regulatory Liaison
Independent Monitoring / Auditing
Ethanol Sourcing

Medical Writing and Scientific Communications               Clinical Trial Operations                Regulatory Liaison            Independent Monitoring / Auditing            Ethanol Sourcing

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