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.

📌 Deputy General Manager (Western India)
🏢 Troikaa Group
📍 Western India