K C Nandhakumar Email & Phone Number

Bengaluru, Karnataka, India

Bengaluru, Karnataka, India

Coimbatore Area, India

Responsible to conducting internal audits.Review of Preliminary study designing of BA/BE studies and Clinical trials.Preparation and Review of protocol, Investigator Brochure’s, sample case report form and Inform Consent Form for various regulatory like USFDA, WHO, EMA, ANVISA, Canada, China, ROW, DCGI etc,Preparation of sample size calculation for BA/BE studies.Review of Pharmacokinetic Data Analysis & Statistical results.Preparation and Review ofClinical Trial Report, Clinical Study Report, Bioanalytical Report. Finalizing the clinical trial report and clinical study report with eCTD specifications to followE3 guidelines as per various regulatory guidelines (USFDA, WHO, EMA, ROW, China and DCGI etc). Responsible to address the sponsor and Regulatory related queries.Monitoring and verifying of Pharmacy related activities and documents – InvestigationalMedicinal Product (IMP) Acknowledgement, Accountability of IMP, Dispensing of IMP, labeling of IP and Retention of IMP.Verification of protocol/SOP deviation record and clinical study/summary update which includes reporting of AEs/SAEs occurred during study conduct to the sponsor/Ethics committee as required.Review of Trial Master File (TMF).Site monitoring before every study initiation to ensure availability of study materials andreadiness of the clinic and ICU to conduct study as per requirements. Monitoring and review of Volunteer Management activities and documents – includes, review of screening records of volunteer, monitoring screening activities, consent obtaining (Both Screening and Study related inform consent document).Monitoring and verification of dosing activity, blood sample collection, safety assessment, sample processing & separation, segregation of bio samples and transformation of samples to Bio-Analytical lab activities along with related documents to ensure whether the activities/documentation.Responsible for SOP revisions, corrections & implementation.