Essential Documents review

Who likes unanticipated results. In Clinical Research there are multiple chances of small error which becomes deciding factor for success of any Trials. It becomes very essential to identify root cause of error by investigation for its corrective as well as preventive action. Pharmazone Auditors are having niche experience in such kind of audits and will analyze project with 360° investigation approach with utilizing all expertise from formulation, biostatistics, clinical and bioanalytical as needed, to find out the any possible reason.

• This helps in finding out any issue/human error in the conduct of a study.
• Correlating sequencing of event in chronological order to identify the error or cause of error.
• To search any assignable cause that may have caused any anomaly by reviewing all clinical, bioanalytical, PK-state data together to see the possible correlation.
• To see the impact of protocol design on such outcome.
• To design the best possible way forward.