Tarun Raghu Email & Phone Number

Bengaluru, Ka, In

Bengaluru, Karnataka, India

Responsible for performing feasibility, site identification, site contract negotiation, and other SSU activities.Provide country-specific SSU expertise to study start-up team leads and project teams.Responsible for the preparation and coordination of submissions to regulatory, ethical, and other bodies.Develop, finalize, and review master and country-specific subject information sheets and informed consent forms.Worked on Due Diligence ChecksResponsible for critical findings and updates related to debarments, warning letters, etc. from the FDA or other regulatory databases.The following checks are performed by the Due Diligence team to identify any findings/issues noted by any investigator and update the Isprint database accordingly by reporting the same to the site ID team for further action from their end.Worked on eTMF (Electronic Trial Master File)Perform TMF Quality Review [Sampling and Coherence] as per the FMP.Create inbuilt workflows to raise action items for the identified issues.Track the progress of TMF QCs using dashboards and reports.

Bengaluru, Karnataka, India

Worked on Active Pharmaceutical Ingredients.

Bengaluru, Karnataka, India

Worked briefly in the formulation plant which includesParenterals (Dry powder injectables),Non-Parenterals(Tablets,Capsules, Powder and Liquid orals). And otherdepartments like Quality control, Quality Assurance, Microbiology department.