Determination of sample size using WinNonlin or SAS Software for BA\\BE studies
Statistical inputs in the study protocol for BA\\BE studies
To generate randomization schedule using WinNonlin or SAS software
Carry out PK\\PD analysis using WinNonlin or SAS for BA\\BE studies.
Statistical inputs in the clinical study report.
Generate .xpt files as per the requirement of the project.
Compilation of the project data and statistical report as per the sponsor’s requirement and regulatory submission
Prepare, review and updating the SOPs of the department.
To ensure that all project related activities are strictly adhered to Standard Operating Procedures (SOPs) of the department and as per the protocol requirement.
The renewal of the Software licenses in the department.
Resolve the queries\\observation raised by Quality Assurance (QA) department.
Handling of archival\\re-archival of the projects in the department.
To give compliance and response to sponsor and regulatory queries.
Any other responsibilities assigned by the Management Representative.
ENEM NOSTRUM REMEDIES PVT. LTD. is integrated drug development solutions provider. We are a rapidly growing contract research organization (CRO) with a portfolio of capabilities partnering with health care companies specializing in generics global... Read More
