CRO

REGULATORY SERVICES

Clini Counsel team has a cumulative experience of more than 10+ Years in Regulatory affairs. Over years, our experts have been Behind breakthrough CRO approvals by helping number of companies from India and the World with a clear Regulatory Pathway for Successful Launch of their products under different Rules in India.

INTRODUCTION

An organisation known as a contract research organisation (CRO) supports the pharmaceutical, biotechnology, and medical device sectors by offering expert services by contracting out research. Additionally, they have the expertise to support government agencies like the European Medicines Agency (EMA) and the National Institutes of Health (NIH), as well as research foundations, institutions, and universities. Development of biopharmaceuticals and biological assays, product commercialization, pre-clinical and clinical research, management of clinical trials, and pharmacovigilance are among the services offered by a CRO. A CRO is a blessing for all of the pharmaceutical as well as research needs because they can multitask within a set time frame. However, it takes effort and a thorough search to find a trustworthy, qualified CRO. When CliniCounsel is available to assist, there is no need to be concerned. A methodical, scientific, and synergistic strategy is offered by CliniCounsel to address all regulatory affairs. We have a team of dependable industry specialists who help our clients get the best CRO for their requirements.

Our network of CROs are skilled to provide support in terms of clinical trials and research, for which a GCT approval is very essential. The flow of GCT is as follows:

  • Application for a GCT approval includes informed consent form, trial site details, investigators brochure, data related to formulation, preclinical data involving animal pharmacological and toxicological studies, results and clinical report of phase I, II, III trials, etc.
  • Checklist of protocol development which includes major as well as minor changes/modifications.
  • Checklist for import license which include TR 6 challan, copy of permission letter for conducting clinical trials, etc.
  • Check for site addition/deletion/closure/change in principal investigator.

Safety reporting is an important component of pharmacovigilance. According to schedule Y, periodic safety update reports (PSURs) are submitted once in every six months for two years and subsequently, once in every two years. PSURs include current worldwide marketing status, update of actions taken for safety reason, etc.

A test license is key for importing any samples of drug, cosmetics, medical device, etc. in small quantities for R&D, testing and analysis purposes. The application content and list of documents to be attached are mentioned in form 11.

CTRI registration is taken care by ICMR’s National Institute of Medical Statistics. It offers a free and online public record system for registration of clinical trials which are conducted in India as well as in case of multi-national trials where India is also participating. Although, it was initiated as a voluntary measure, but, now, trial registration in the CTRI has become an important as well as mandatory step to be followed. For publications, it has become compulsory to provide a registration number for each trial being conducted in India. CTRI includes Indian investigator’s details, trial sites, Indian target sample size and date of enrollment. Once a trial is registered, a regular updating of trial status including changes is mandatory.

Submission of ethics committee registration application is essential to get Ethics approval. A DCGI approval is also extremely important for trial registration in the CTRI. The amendment in the Drugs & Cosmetics Rules vide GSR no. 72 (E) dated 08-02- 2013 inserted a Rule 122DD, in Schedule ‘Y’ along with other amendments. It specifies the detailed procedures for the registration of Ethics Committee. As per Rule 122DD, a prior registration of clinical trial protocol with DCG(I) is mandatory to review and accord its approval. The procedure involves submission of an application for registration of Ethics Committee to the DCG(I) in accordance with the requirements as specified in the Appendix VIII of Schedule Y. To streamline the submission and examination procedure, CliniExperts conducts a preliminary scrutiny where the preliminary scrutiny of the applications will be conducted by our team as per CDSCO guidelines. Then the CDSCO officers will conduct their preliminary scrutiny on the basis of a standardized checklist. The check list includes the list of documents which are to be submitted such as name and address of ethics committee, membership requirement, details of supporting staff, etc. after acceptance of application, the information will be reviewed by officers of CDSCO as per the specified procedures. There is a special and specific format in which the application should be submitted such as with page numbers, serial order of documents attached, etc.

CRO