Prasanna Krishna Patil

• Coordinate study planning, subject screening, and eligibility assessment with clinical teams and investigators
• Review and verify screening documents (ICFs, CRFs, medical records) and maintain study documentation (CRFs, source, TMF)
• Ensure compliance with study protocols, SOPs, and regulatory guidelines
• Supervise dosing, blinding activities, and monitor pre-/post-dose restrictions and meals
• Prepare protocols, ICFs, CRFs, SOPs, conduct SOP trainings, and ensure timely submissions
• Respond to sponsor queries, document protocol deviations, and resolve QA/QC and audit findings
• Prepare clinical study reports and study summary reports
• Prepare, review, and submit applications on the SUGAM portal (BENOC, Test License, Protocol Amendments, IEC Notifications, etc.).
• Handle regulatory submissions, query responses, and approvals from
  DCGI, CDSCO (Central/Zonal), CBN, NCB, and Local FDA.
• Manage narcotic drug approvals, quarterly returns, pharmacy license
  renewals, and director/pharmacist registrations.

• To perform clinical feasibility assessment
• To review of Protocol as per regulatory requirements for accuracy and adequacy
• To prepare and review documents for BENOC and Test license application
• To review and coordinate with CRO for finalization of Clinical Study Report as per ICH E3 and in accordance with respective regulatory requirements
• To review of regulatory dossier (eCTD) as per the requirements of the various regulatory agencies
• To coordinate with Sponsor and CRO to ensure study resources (IMPs and study schedule) to meet the study timelines
• To conduct CRO qualification audit, preparation of audit report, gap identification and CRO selection
• To conduct site initiation, visit (SIV), in-process monitoring in Period, I, Period-II or as per study design to monitor dispensing, dosing, safety assessment, PK sample collection etc
• To conduct retrospective review of source data from BE study
• To track all activities project inception to dossier delivery

• Assess feasibility for new client requests and prepare quotations.

• Communicate with clients regarding feasibility, technical aspects, and study planning.

•Coordinate with internal teams (clinical, bioanalytical, statistical, QA, and management) for study execution.

•Monitor study progress, update clients, and manage project risks.

•Oversee project scheduling, timelines, and administrative aspects.

•Prepare, review, and submit applications on the SUGAM portal (BENOC, Test License, Protocol Amendments, IEC Notifications, etc.).

•Handle regulatory submissions, query responses, and approvals from DCGI, CDSCO (Central/Zonal), CBN, NCB, and Local FDA.

•Manage narcotic drug approvals, quarterly returns, pharmacy license renewals, and director/pharmacist registrations.