CRO

CRO

Introduction

A contract research organization (CRO) is an organization supporting the pharmaceutical, biotechnology, and medical device industries by providing professional services by outsourcing research on a contractual basis. They are also highly skilled to support research foundations, institutions, and universities as well as the governmental organizations including National Institutes of Health (NIH) and European Medicines Agency (EMA). The services provided by a CRO include development of biopharmaceuticals and biological assays, commercialization of products, pre-clinical research, clinical research, management of clinical trials, and pharmacovigilance. To perform multitasking in a defined timeline, a CRO is a boon for all the pharmaceutical as well as research needs. However, searching a reliable, certified and skillful CRO needs extensive survey and time. There is no need to worry when CliniExperts is there to help! CliniExperts provides a systematic, scientific and synergistic approach to handle all regulatory affairs. We have a set of reliable, industry experts who assist our clients to collaborate the perfect CRO for their needs.

CRO Support: A multitasking approach

1. Global Clinical Trials (GCT) approval – 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.
2. Safety reporting – 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.
3. Test license – 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.
4. Clinical Trial Registry India (CTRI) Registration – 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.
5. Ethics Committee Registration – 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.

CliniExperts: A multitasker

1. We provide one roof for all your regulatory issues, beginning from filing till approval.
2. We ensure complete client satisfaction by providing post-task services, in case of changes/ modifications.
3. We, as a team, strive hard to get the job done not just well in time, but well before deadlines.
4. We offer cost effective deliverables with accuracy and precision.
5. We help the client in searching the best, certified and skilled CRO to get most competitive services for their custom requirements.
6. We provide them the list of documents required for the fulfillment of procedure, where the forms (related to regulatory affairs) are provided by us.
7. We assist client in filling up of the forms where even a single error might lead to delayed submission and approval.
8. We take care of all the challenges which can hinder the process flow by lubricating the path by our subject knowledge, skills and expertise.
9. We try to get the approvals in one go, that too hassle free.
10. We strive hard to keep the client stress free, by saving their time. For this we take care of the procedure from retrieving forms to procuring the approval.
11. We assist in filing of GCT for smooth running of the trials.
12. We ensure that the PSURs are filed thoroughly so as to support the pharma covigilance system.
13. Our skilled team of experts ensures that the application and documents required for ethical committee registration are attached in serial order so as to achieve acceptance of form.
14. We also support client in filling the technical details to pass through further scrutiny procedures.

Overall, CliniExperts is a single hand service provider, with an expertise to resolve multiple regulatory challenges given our years of experience in the field of healthcare.