Bio-Scientific Research Laboratories Pvt. Ltd.

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Description of Work Plan

For each project, a study director and principal investigator are appointed.
The study drug (test and reference) is acquired along with the certificate of analysis (CoA).
The study specific protocol and informed consent form (ICF) are prepared.
The study specific protocol and informed consent form (ICF) are submitted to the independent ethics committee (IEC) for approval.
The volunteers are presented with the independent ethics committee (IEC) approved informed consent form (ICF).
On signing of the IEC approved ICF, Volunteers undergo the screening, medical examination and laboratory examinations.
Based upon the screening, medical examination and laboratory examination reports subjects for the study are selected.
A randomization schedule of the drug administration (test and reference) is prepared by the statistician.
The study is conducted as per the study specific protocol and SOPs.
The final report is prepared by the integration of the clinical report with the analytical report.


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