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Track 3 Session 3: Clinical Investigation Core Components
Session Chair(s)
Priyadarshini Arambam
Academics & Research Department - Batra Hospital and Medical Research Centre
General Manager - Clinical Research Operations, India
The evaluation of medical devices through clinical investigation entails a comprehensive and organized methodology that assesses the safety, effectiveness, and performance of the device in question.
Undertaking clinical investigations for medical devices presents distinct obstacles arising from the inherent characteristics of these devices, the regulatory landscape, and the necessity for specialized knowledge.
In this session, we will deal with nuances related to operations, data management and data analysis.
Speaker(s)
Clinical Data Management And Medical Coding for Medical Devices – Best Practices And Recommendations
Utkantha Kulkarni
KlinEra Global Services, India
Sr Manager CDM
Coming Up the Device Way – Clinical Operations Nuances
Pallavi Singh
Abbott, India
Associate Project Manager,
Dialogue Interview: Differentiating Analytics And Statistics And Real-world Evidence For Medical Device
Manish Narang
Abbott Vascular, India
Director Medical Affairs APAC
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