About Aceas -IEC

Aceas -IEC  is constituted for protection of the rights, safety, and well-being of clinical trial subjects (patients and healthy human volunteers) participating in clinical trials at the sites of Contract Research Organizations, Hospitals, and Clinics, in conformation to the requirements and guidelines of:

  • Good Clinical Practice (GCP), Guidance for Industry, E6, developed by the Expert Working Group (Efficacy) of the International Conference on Harmonization for the Technical Requirements for registration of Pharmaceuticals for Human Use (ICH), for adoption to the regulatory bodies of the European Union, Japan, and the United States.
  • Good Clinical Practice Guidelines for Clinical Research in India, Central Drug Standards and Control Organization, Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India, New Delhi.
  • Ethical Guidelines for Biomedical Research on Human Subjects, Indian Council of Medical Research, Government of India, New Delhi.
  • Schedule-Y of the Drugs & Cosmetics Act, 1945.
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