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T2S5: Trust Through Transparency: The Future of Clinical Trial Communication
Session Chair(s)
Sonica Sachdeva Batra, MD
Associate Vice President Enterprise Medical;Global Head- Regulatory Affairs
Indegene Ltd., India
As the global clinical research landscape evolves, transparency has emerged not just as a regulatory mandate but as a cornerstone of public trust. This session will explore how modern transparency practices are transforming clinical trial communication, offering insights into how transparency is being redefined to serve regulators, researchers, and most importantly, patients. We will delve into the impact of the EU Clinical Trials Regulation (EU-CTR) in elevating disclosure standards and reshaping sponsor responsibilities. The session will also highlight the growing importance of plain language summaries, both for protocols and results, as a means to foster meaningful engagement with patients and the public. Additionally, we will examine anonymization methods and their pivotal role in ensuring data privacy while preserving the utility of clinical data. Throughout the session, we will emphasize the evolving and strategic role of the medical writer in driving these initiatives — shaping content, ensuring compliance, and acting as a bridge between regulatory expectations and patient needs.
Speaker(s)
Clinical Trial Transparency- The Need, Current Status And The Way Forwards
Sonica Sachdeva Batra, MD
Indegene Ltd., India
Associate Vice President Enterprise Medical;Global Head- Regulatory Affairs
Evolving Role of Medical Writers Towards Ensuring Clinical Trial Transparency
Priyanka Kumari, DMD
Indegene, India
Director, Regulatory Affairs & Labeling
Regulatory Document Submissions, Anonymization Techniques And EU CTR
Sandeep Undavalli, MS
Novo Nordisk Service Centre India Private Ltd, India
Clinical Transparency Specialist
With the Additional Presence of
Pooja Phogat, Ph.D, PhD
Krystelis Ltd., India
Founder and Co-CEO
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