Novel System Development Techniques in Clinical Trials

Authors

  • Sasidhar Duggineni Compliance Manager, Pharmaceutical Product Development Author

DOI:

https://doi.org/10.47363/f4f35q85

Keywords:

Data Governance, Data Integrity, Data Management, Data Security, Technical Controls, Regulations

Abstract

Data Integrity Improvisations can capture measures as clinical trial participants go about their daily lives. These measures can be used as novel endpoints, defined as new endpoints that have not previously been possible to assess or (2) existing endpoints that can be measured in new and possibly better ways. Because novel endpoints have the potential to provide high-quality data pertaining to outcomes that are meaningful to patients while enabling broader, more accessible trials with reduced barriers to participation. Data Integrity (DI) enhancements focus on measures that are meaningful to patients and clinically relevant. Data Integrity (DI) enhancements Identify key endpoints by assessing and meeting the needs of each stakeholder.

Author Biography

  • Sasidhar Duggineni, Compliance Manager, Pharmaceutical Product Development

    Sasidhar Duggineni, Compliance Manager, Pharmaceutical Product Development.  

Downloads

Published

2022-01-18