Pharmaceutical Regulatory Affairs: Open Access

Tapan Kumar Pal

Publications

• Review Article
  Digitization of Clinical Trials in India: A New Step by CDSCO towards Ensuring the Data Credibility and Patient Safety
  Author(s): Shubhasis Dan, Sanmay Karmakar, Balaram Ghosh and Tapan Kumar PalShubhasis Dan, Sanmay Karmakar, Balaram Ghosh and Tapan Kumar Pal
  
  Supervision provides a foundation for future workers to learn practical skills from a qualified professional, and is essential for the development of a profession. Supervision is also very much essential for developing workforces. Recently CDSCO has proposed to create an IT enabled system for online submission of various information on clinical trials to streamline the process of approval, maintaining comprehensive database and monitoring The clinical trials for ensuring the protection of rights, safety and well beings of trial subjects and authenticity of the data generated. Looking at the current regulatory environment .. Read More»
  DOI: 10.4172/2167-7689.1000149

  Abstract PDF