Participated in monitoring and co monitoring visits- Approximately 200 to 300 monitoring experience at various sites all over India1. SEV (Site Evaluation Visit) The purpose of the visit is to monitor the facilities for the conduct of the Clinical Trial. The initial meeting with the investigator is scheduled at this visit in which the details of the trial are discussed. The visit also determines the need of providing GCP training at the site2. SIV (Site Initiation Visit)The… Show more Participated in monitoring and co monitoring visits- Approximately 200 to 300 monitoring experience at various sites all over India1. SEV (Site Evaluation Visit) The purpose of the visit is to monitor the facilities for the conduct of the Clinical Trial. The initial meeting with the investigator is scheduled at this visit in which the details of the trial are discussed. The visit also determines the need of providing GCP training at the site2. SIV (Site Initiation Visit)The purpose of this visit is to finalize site for the conduct of the study. The documents are filed properly and the responsibilities are given to the site staff.3. Interim MonitoringOn-Site & In-house monitoring as per monitoring plan in order to check & ensure compliance with study management, protocol GCP & other requirements at all assigned sites.Monitor study-related documentation ICD, Source Data CRF, Drug accountability logs at the site to check & ensure the completeness & accuracy with compliance to protocol GCP, GLP & regulatory.Identify and assist in reporting SAEs to sponsors and regulatory authorities coordinate in generating CRF data and all other activities with the clinical research team. Reporting of study progress at regular intervals, to study manager and Sponsor.4. Study Close-outWith comprehensive overview of study relevant documents retrieval of CRFs, Complete Drug accountability & Destruction, resolving Budget & other miscellaneous issue & Submission of final study report to the regulatory authority and ethics committee. Show less