Contacts

Unit 863, Cospacio: Premium Coworking, 8th Floor, Celica Park, 24, Park Street Park Center, Kolkata, West Bengal 700016
contact@orcivita.com
+91 91473 10088
Ethics Committee

Ethics Committee (ECMS) Registration & Management Services

OrciVita provides end-to-end Ethics Committee (ECMS) registration, re-registration, and management services to hospitals, institutions, and research centers across India. Our services are designed to ensure full compliance with NDCTR 2019, ICMR Ethical Guidelines, and ICH-GCP requirements, while reducing administrative and operational burden for institutions.

EC Registration Services

OrciVita supports hospitals and institutions seeking to establish their Institutional Ethics Committee (IEC) from inception. Our services include:

  • Guidance on EC constitution as per regulatory requirements
  • Complete documentation support for EC registration
  • Development and implementation of EC SOPs
  • Assistance with EC member onboarding and role clarity
  • Submission support and follow-up with regulatory authorities
  • GCP training and clinical trial orientation for site team

EC Re-Registration & Management Services

For institutions with already registered ECs, OrciVita offers comprehensive EC re-registration and ongoing management support, including:

  • Documentation review and preparation for EC re-registration
  • Gap analysis and regulatory compliance assessment
  • Arrangement and coordination of EC meetings
  • Quorum and member availability management
  • Support to EC members during protocol and dossier review by providing complete and compliant documentation
  • Maintenance of EC records, minutes, and correspondence
  • Ensuring inspection and audit readiness
Track Record & Experience

OrciVita has successfully supported multiple EC registrations and re-registrations, including:

  • VIMS EC re-registration (2019)- Registration
  • AMRI Salt Lake EC (2020) – now Manipal Hospitals
  • OrciVita Independent Ethics Committee (2020) -Registration
  • OrciVita Independent Ethics Committee (2025) -Re-registration

Currently, multiple EC registration and re-registration projects are ongoing, with OrciVita providing comprehensive regulatory and documentation support.

OrciVita Independent Ethics Committee (IEC)

In addition to providing EC services, OrciVita has its own Independent Ethics Committee (IEC), which functions as an autonomous and unbiased ethical review body. Importantly, this IEC reviews only those clinical trials in which OrciVita is not involved, ensuring independence and avoidance of conflict of interest.

  • First Registration: October 2020
  • Re-registration Approved: 22 December 2025

The OrciVita Independent EC operates strictly in accordance with NDCTR 2019, ICMR Ethical Guidelines, and ICH-GCP, with clearly defined SOPs, quorum requirements, and conflict-of-interest management processes.

Get in touch with us: iec@orcivita.com

EC Memberlist

The OrciVita Independent IEC is constituted as per regulatory requirements, comprising medical, non-medical, scientific, non-scientific, legal, and social representatives to ensure balanced and ethical decision-making.