CLINICAL TRIAL UNIT
- Government Institute of Medical Sciences (GIMS), Greater Noida, is an autonomous tertiary care institute of Government of UP, with a mission to provide affordable health services to all sections of the society and has been envisioned to be in the forefront of providing state of the Art Patient care, excellent medical education and multi-disciplinary research. The institute has started MBBS (2019), College of Nursing (2021), Institute of Paramedical Sciences (2021) and Post Graduate courses (MD/MS) in 13 specialities in 2024.
- GIMS hospital is the only Govt hospital in UP to have NABH and NABL certified by the quality council of India. The treatment facility at GIMS completely free for Pregnant females, Ayushman bharat patients, emergency patients, Trauma and accident cases, destitute patients and all the poor patients reporting to GIMS.
- Clinical Trial Unit (CTU) was set up by the Government Institute of Medical Sciences, with an aim to centralize the management of clinical trial studies to set quality of ethical research. CTU-GIMS is a listed centre of Indian Clinical Trial and Education Network (INTENT), established by the Indian Council of Medical Research (ICMR), Government of India. Our commitment is to improve the quality of human life & to provide world class clinical research services to pharmaceutical, biotechnology, medical device, in-vitro diagnostics companies, and funding government organizations.
- We wish to focus on the prevailing issues in clinical research & give their solutions with a fresh and rational approach. In this endeavour, we have successfully established a team of highly qualified and experienced multi-disciplinary GCP trained personnel. The services provided by CTU are knowledge-driven and based on the understanding of the pharmacology and molecular basis of disease. We believe in providing quality services & we prioritize customer relationships.
- CTU team comprise of highly qualified and experienced professionals who manage all aspects of Phase III and Phase IV studies including:
- Development of essential clinical trial documents (Protocol, ICD, CRF and Investigator Brochure)
- Feasibility of clinical trial studies.
- Add-on Investigator site selection and management.
- Dossier preparation and submission to Institutional Ethics Committee (IEC)
- Internal Monitoring and audit of Add-on clinical trial sites.
- Clinical trial material logistics and management.
- Analysing and preparation of clinical study reports.
- Responding to regulatory agency’s request for information pertaining to patient safety<
- CTU provides as additional services of regulatory affairs consultancy tailored to meet our start-ups and client’s specific needs as well. Client’s data security and confidentiality is assured to the highest level. Our regulatory team have significant experience in development of Dossiers of Clinical Trial Document (CTD). We provide services from submission to final approval of regulatory documents at the office of DCG (I), FDA Bhawan, New Delhi. We facilitate the guidelines for getting approval / N.O.C. for following applications:
- Finished Formulations
- Medical Devices and IVDs
- Vaccines
- At CTU, we ensure that timelines are met and quality is maintained. Responsibilities, processes and expectations are clearly defined at an early stage for a smooth Therapeutic Drug Monitoring & Clinical Data management execution. CTU offers services for management and execution of Therapeutic Drug Monitoring & Clinical Data Management from single centre to multi-centric studies in a variety of therapeutic areas.
- CTU offering all medical writing services from Phase I to IV clinical studies. Our medical writing team comprises of physician and pharmacologists who have sound experience in developing documents in various therapeutic areas such as Cardiology, Diabology, Dentistry, Dermatology, ENT, Gastroenterology, Gynaecology, Haematology, Infectious Diseases, Nephrology, Neuropsychiatry, Ophthalmology, Orthopaedics, Oncology, Paediatrics, and Respiratory and pulmonary Disorders.
- Our team have expertise in scientific writing, abstracts, posters, manuscripts and SOPs development. Documents are prepared strictly in accordance with ICH/EU/US guidelines and regulations.
- The medical writing team has access to excellent translating services ranging from patient information sheet, Patient Diaries, ICD, CRF, Product Labels, Pharmacology Reports, Toxicology reports, Clinical Study Reports (CSR) and Investigator Brochures. We are providing translation services in 70+ languages.
- Call Centre services to sort and compile adverse event data
- Literature search
- Data processing and reporting to regulatory authorities
- Periodic Safety Update Reports (Preparation of PSURs)
- Preparation of Individual Case Safety Reports (ICSR)
- Skill Development Certificate Programme & Courses
- Workshops & Conferences
- CMEs
- Webinars & Seminars
SERVICES
CLINICAL TRIAL OPERATION & MANAGEMENT
REGULATORY AFFAIRS
In short, we serve the entire spectrum of regulatory needs for our clients, based on experience and knowledge
CLINICAL DATA MANAGEMENT
MEDICAL WRITING & TRANSLATION
POST MARKETING SURVEILLANCE
GIMS is a registered centre for adverse drug reaction monitoring under Pharmacovigilance Program of India (PVPI). Under the PVPI, CTU offers Post-Marketing Surveillance or Pharmacovigilance services that help the sponsors in collecting, comparing, processing, tracking, and reporting the possible adverse events to determine safety of products.