Dr. Kuriakose Joy
About Candidate
Review of preliminary study designing of BA/BE studies and Clinical Trials.
Preparation and Review of Study Details, Protocol, Investigator Brochure, Sample Case Report Form and Informed consent Documents for various regulatory like USFDA, WHO, EMA, ANVISA, Canada, China, ROW, DCGI etc.,
Preparation and sample size calculation for BA/BE studies.
Responsible to address the sponsor and Regulatory related queries.
On site monitoring of trial and Review of Trail Master File (TMF) before initiation of study, during the conduct of study and after completion of study.
Monitoring and verifying of Pharmacy related activities and documents – Investigational Medicinal Product (IMP) Acknowledgement, Accountability of IMP, Dispensing of IMP, Labeling of IP and Retention of IMP.
Handling of Investigational Medicinal Product for BA/BE studies and Clinical Trials.
Generation of Randomization Schedule using R Studio.
Handling of Randomization schedule for BA/BE studies and Clinical Trials.
Handling of BA/BE and clinical trials documents.
Responsible for SOP revisions, corrections and implementation.
Ethics Committee Coordination.
Preparation of Study Update and Summary Updates for clinical Trials.
Preparation and Review of Clinical Trial Report & Clinical Study Report.
Review of Pharmacokinetic Data Analysis & Statistical Results
Worked as Trainer in Naan Mudhalvan scheme for Clinical Trials
Trainer for clinical trials, BA/BE studies, Pharmacovigilance and GCP.
