In reference to the clinical development of Biologicals (Vaccines and Biotherapeutics), one of the needs identified by Biotech companies is the challenge in accessing trained and equipped clinical trial sites in the country. Clinical trials are currently an important bottleneck in the product development process as companies usually have to go through an ad hoc process of finding sites with access to the required target population. To solve this bottleneck, National biopharma Mission (NBM) will support the establishment of a clinical trial networks (CTN) for specialties of Diabetology, Ophthalmology, Rheumatology, Oncology and strengthen clinical trial capacity in the country.

 

To support vaccine development, epidemiology studies of relevant diseases in healthy cohorts will be carried out in already existing Demographic Surveillance System (DSS) sites in the country. These sites will also be further strengthened for conduct of GCP compliant clinical trials. For complete geographical representation additional DSS or DHS (Demographic Health System) sites will be established for subsequent epidemiology studies.

 

The vision of the Program is to enable and nurture an ecosystem for preparing India’stechnological and product development capabilities in biopharmaceuticals including vaccines,biologics, medical devices and diagnostics to a level that will be globally competitive over the next decade. Through this RFP, NBM proposes to establish Clinical Trial Networks (CTNs)and Strengthen Clinical trial capacity.

 

KEY FEATURES OF THE CALL: The call is to seek Letter of Intent (LoI) for the Request for Proposals (RFPs) mentioned below:

 

RFP 1:To establish Clinical Trial Networks (CTNs) for hospital-based trial in specialties of Diabetology, Ophthalmology, Rheumatology and Oncology.

 

RFP 2:To study epidemiology of Dengue & Chikungunya in different age-groups at existing DSS/DHS/DDESS* site(s) and to further prepare the sites for conduct of GCP compliant field-based clinical trials.

 

RFP 3: Establish new DSS/DHS/DDESS* sites within the country to have complete geographical representation of potential trial sites and to study epidemiology of Dengue & Chikungunya in different age-groups at these sites.

*Demographic Surveillance System / Demographic and Health Surveillance / Demographic, Development and Environmental Surveillance System

 

RFP 4: To Establish data management platform: An IT platform for community-based data collection, analysis and reporting.

 

For queries contact:

Mission Director, PMU-NBM: technical.birac@gov.in

 

Announcement Date: 15-08-2019

Last Date of Submission of Letter of Intent (LoI): 10-10-2019 (02:00 PM)

Last Date of Submission of Full Proposal: Will be communicated through email to shortlisted applicants after screening of LoI

 

For further details: https://birac.nic.in/webcontent/1565800186_ctn_rfp.pdf

Through this RFP, NBM proposes to establish Clinical Trial Networks (CTNs) and Strengthen Clinical trial capacity