Clinical Research work

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Clinical Research work

NGMC's clinical research department specializes in conducting and enabling innovative and systematic research with the goal of advancing healthcare in a positive direction. We have dedicated facilities and teams to support clinical trials and research, making them capable of assisting both clinicians and organizations in the development of new healthcare delivery systems.

The department's services encompass the entire research cycle, from feasibility studies to archival. We prioritize upholding NGMC's rigorous ethical standards and ensuring compliance with regulatory requirements when conducting clinical trials. This commitment ensures the safety, well-being, and rights of the subjects involved.

Trials conducted at the site:

1. This is with reference to Vi-DT phase 3 clinical trial of the study entitled "A Phase III Multicenter, Observer-Blinded, Randomized, Active Controlled, Immune Non-inferiority and Safety Study of Diphtheria Toxoid Conjugated Vi-Polysaccharide Typhoid Vaccine compared to Typbar TCV® in healthy 6 months-45 years aged Nepalese participants. Which was started on NOV 2019 and ended on March 17 .

Study Timeliness

Main Study:

S.No Sites
1 Nepalgunj Medical College Nepalgunj
2 Kanti Children Hospital, Kathmandu
3 School of Medical Sciences Kathmandu University, Dhulikhel
4 B P Koirala Institute of Health Sciences, Dharan

These are the sites involved in the study of Vi-DT phase 3 clinical trial conducted by International Vaccine Institute among which around 2,500 people were enrolled as a participants.

Nepalgunj Medical College, Nepalgunj which includes

Main Study:

Sites Study Completed
Nepalgunj Medical College Nepalgunj 438

Additional Study:

Sites Study Completed
Nepalgunj Medical College Nepalgunj 100

2. “A Phase III, Multicenter, Observer-Blinded, Randomized, Active Controlled Trial to Evaluate Immune Non-Inferiority, Safety and Lot-to-Lot Consistency of Oral Cholera Vaccine-Simplified Compared to Shanchol TM in 1 to 40 years old Healthy Nepalese Participants.Which was started on OCT 2021 and ended up on 29 Nov 2022 .

The study was conducted according to the protocol and in compliance with International Council for Harmonization (ICH)E6 (R2) Good Clinical Practice (GCP), Belmont Principles, CIOMS guidelines, Declaration of Helsinki and other applicable regulations in the National Regulatory Agency and sponsor requirement.

These are the sites involved in OCV-S Project around which 2,530 participants were involved.

S.No Sites
1 Nepalgunj Medical College Nepalgunj
2 Kanti Children Hospital, Kathmandu
3 School of Medical Sciences Kathmandu University, Dhulikhel
4 B P Koirala Institute of Health Sciences, Dharan

Nepalgunj Medical College, Nepalgunj which includes;

Sites Study Completed
Nepalgunj Medical College Nepalgunj 632

3. Ref:“A parallel-group, Phase III, multi-stage, modified double-blind, multi-armed study to assess the efficacy, safety, and immunogenicity of two SARS-CoV-2 Adjuvante Recombinant Protein Vaccines (monovalent and bivalent) for prevention against COVID-19 in adults 18 years of age and older as a primary series and open-label extension to assess immunogenicity, safety, efficacy of a monovalent booster dose of SARS-CoV2 Adjuvanted Recombinant Protein Vaccine”.

These are the sites involved in VAT00008 Project ,which was started on September 2021;

S.No Sites
1 Nepalgunj Medical College Nepalgunj
2 Kanti Children Hospital, Kathmandu
3 School of Medical Sciences Kathmandu University, Dhulikhel
4 B P Koirala Institute of Health Sciences, Dharan

Nepalgunj Medical College , Nepalgunj which includes

Main Study:

Site Study Completed
Nepalgunj Medical College Nepalgunj 915

Additional Study:

Site Study Completed
Nepalgunj Medical College Nepalgunj 260

Other program like: Rota surveillance program, Retrospective study on Typhoid and others under pipeline

To ensure each clinical study is conducted in ethical and safe manner that offers the highest possible quality with clean and accurate data, meeting international standards cost effectively on time, every time. To collaborate and support sponsors with premier clinical, regulatory, and scientific expertise in developing sound, scientific strategies that will expeditiously move their products to market. Enduring and enhancing the relationships with the clients.