Hear from the Expert’ Speaker Monthly Series by Clinical Data Management Council
ISCR West Chapter is happy to organize Monsoon Virtual Bootcamp Series in Sep-2025.This Bootcamp focuses on imparting knowledge and experience sharing by industry experts on interesting topics pertinent to all clinical research professionals.
Workshop overview: This workshop aims to strengthen the efficiency and strategic thinking of medical writers and clinical professionals involved in early-phase development. The focus is on authoring high-quality pre-IND briefing documents and scientific advice questions that guide regulatory interactions and early phase development strategy.
Introduction:- The ISCR is pleased to announce the launch of a focused monthly webinar series designed specifically for Clinical Research Coordinators (CRCs). This initiative aims to support continuous professional development and enhance the operational excellence of CRCs across clinical research sites in India.
Regional Training Centre, Department of Clinical Pharmacology and Therapeutics, NIMS, Hyderabad In collaboration with
Indian Pharmacopoeia Commission (IPC), Ministry of Health and Family Welfare
&
Indian Society For Clincal Research (ISCR)
Venue: Novo Nordisk Service Centre India Private Ltd., Plot No 75, CIGNUS, 10th floor, Road #7, 2nd Phase, EPIP Area, Whitefield, Bangalore - 560 066
Overview: Two-day interactive workshop featuring expert-led sessions, case studies, and group activities. This workshop aims to provide a comprehensive understanding of Real-World Evidence (RWE) studies, protocol development, study design, ethical considerations, statistical analysis, and reporting. It brings together industry experts to share practical insights and facilitate hands-on learning through case studies and group discussions.
Workshop Highlights:
The workshop offers a comprehensive understanding of content and Quality Review (QR) approach to key safety documents such as DSUR, PSUR, and RMP. Participants will gain insights into data integrity checks of safety deliverables with interactive sessions and hands-on exercises; practical guidance on review strategies and integration of technology to enhance QR workflows; and a panel discussion on adopting lean QR approach in accelerated submissions.
Timing: 9.30 am to 5:30 pm