Troikaa Pharmaceuticals - DGM/GM - Clinical Trial

To Support in Development of Clinical Trial Protocol

- Review of published literature

- Review of pre-clinical & BA/BE reports

- Preparation of drat protocol

- Co-ordinate review of protocol with Medical Services & other department

- Preparation of appendices, Patient diary, activity schedule

Development of Informed Consent Document

- Review protocol

- Preparation of Draft ICD and co-ordinate review

- Translation and back translation of ICD as and when required

Updating Clinical Trial SOPs

- Updating Clinical Trial SOPs

- Train Medical Service Department personnel on updated SOP

- Design logs and forms, index, separators

Clinical Trial Operations:

- Preparation of protocol related presentation for SEC meeting

- Protocol training to study personnel

- Site selection and feasibility

- Co-ordination for site documents like: CDA, Feasibility Questionnaire, IU etc.

- To support investigators for EC submission and query resolution

- To Support in Preparation & Conduction of Site Initiation Visits

- Monitoring of Clinical Trial Sites

- To Support in Preparation & Conduction Site Closeout Visits

- Site Visits: SIV, SMV, SCV

- Review and approval of site visit reports

- Development and Maintenance of Trial Master File

- Site follow up for patient recruitment and pending action items

To Support in Development & Compilation of Clinical Study Report

To Support in Pharmacovigilance Function

- Knowledge about Pharmacovigilance system

- Medical Review of ICSRs

- Knowledge about MeDRA and WHO-DD

- Review of PSURs / RMP etc.