Ethics Committee Services

Ethics Committee Services In India, it is a legal requirement that any sponsor, organization or institution which is conducting a clinical trial should seek the approval of an Ethics Committee in order to ensure compliance with ethical principles and Good Clinical Practice (GCP). The Ethics Committee is assigned the task of reviewing the clinical trial designs, vetting investigators and sites, approving the ethics of the informed consent procedures. Institutional, and Independent Ethics Committees are active in the clinical trial processes, bioavailability and bioequivalence studies, and biomedical and health research as well.

Ethics Committee Registration & Re-Registration

Ethics Committee Registration & Re-Registration The Ethics Committee of India is, however, unable to function without being pre-registered with the Central Licensing Authority of India. Such registration is important as it guarantees transparency, control and quality of management of ethical issues during the conduct of clinical trials in India. A sponsor or organization that wishes to register an Ethics Committee must specifically complete and submit as required by CT-01 Form of New Drug and Clinical Trials Rules, 2019 and other requirements to register an Ethics Committee.

Curaclin Research offers easy registration as well as re-registration for the Ethics Committee as per the laws. It does not matter whether it is the first time you apply for Ethics Committee’s or if you want to renew the registration; we help you throughout the process and also in preparation and submission of necessary papers and documents.

Renewal Process:Applications for renewal of registration will be submitted 90 days before the date of expiry of registration; in this case, as well, when nothing has changed since the time of registration, no new documents are required. We may assist to file renewals in accordance with the requirements of the CLA, so that the work of Ethics Committee is not interrupted.

Amendments & Updates: The changes in relation to the changes SOPs or changes in the committee membership to the Registrar are lodged also by us to ensure smooth operations of the Ethics Committee and its continued validity of registration.

End-to-End Support for Ethics Committee Registration

Selective ServicesWe prepare and submit any kind of registration or renewal application in full or assist in other tasks related to application preparation, Whenever necessary, relevant documents are submitted, and any formalities required are satisfied in order to ensure approval speed

SUGAM Portal Support: Submissions through the SUGAM portal for CDSCO, and efforts are made to chase up on submitted applications to render assistance with cases where there are outstanding queries.

Maintenance Phase activities: Addressing the need for practice, management and support of clients to ensure regulatory changes and changes in the composition of committees are adhered to.

At Curaclin Research, we simplify the complexities of Ethics Committee operations, enabling sponsors and institutions to focus on advancing clinical research while ensuring strict adherence to ethical and regulatory standards

Contact us today to streamline your Ethics Committee registration and compliance processes.