Call For Proposal

Request for Proposals RFP for establishing Clinical Trial Networks CTNs and Strengthening Clinical Trial capacity, Last Date: 10th Oct, 2019, 2PM

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 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.

The proposals can be submitted:

• Solely by Non-profit organizations / Societies / Trusts/ Foundation/ Associations/ Government entities/ Institutes/ Institutes established under Acts/statute OR

• Jointly by Non-profit organizations / Societies / Trusts/ Foundation/ Associations/ Government entities/ R&D Organizations / Institutes established under Acts 

Criteria Particulars for the Proponent entities 

Non-profit organizations/ Government entities/ Institutes/ R&D Organizations

This will include Academic Research Institutes, Universities, Research Foundation, Medical Colleges and Institutes – both public and private who are valid legal entities such as Trust, Society or established under central or state statute.

Relevant documents to be submitted at the time of LoI submission:

Applicant being an Indian academic scientist and researcher:

a. Copy of passport (from academic scientists & researchers) or self-declaration of Citizenship attested by a gazetted officer.

b. A declaration/authorization in favour of applicant, issued by Host Organization (which states that the host organization is willing to give facilities to applicant for the project applied for).

Indian institution/ universities/ public research organization:

a. Affiliation/registration certificate or statute reference for establishment.

b. Details regarding in-house R&D facility, if any.

c. If the institution/public research organization are registered under/as Society or Trust, then they have to submit the documents as mentioned in the case of Society/Trust.

Society/ Trust/ NGO/ Foundation/ Association:

Society

a. Society registration certificate and Byelaws

b. Details regarding in-house R&D facility, if any.

c. CA certificate (supporting the fact that half of the members of the society are Indian citizens)

Trust

a. Trust deed and Registration Certificate

b. Details regarding in-house R&D facility, if any 

c. CA certificate (supporting the fact that half of the members of the trustees are Indian citizens)

NGO/ Foundation/ Association

a. Registration details/ certificate.

b. Details regarding in-house R&D facility, if any.

c. If the NGO/ Foundation/ Association are registered under/as Society or Trust, then they have to submit the documents as mentioned in the case of Society/ Trust.

Letter of Intent (LoI) to be submitted online only. For LoI submission please log on to www.birac.nic.in. For details on Request for Proposal (RFP) and Mission Document, log on to:    www.birac.nic.in/nationalbiopharmamission.php

Call Opens: 15th August 2019; Last date of Submission: 10th October 2019 (2:00 PM)

For queries please contact:

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

ANNOUNCEMENT DATE | LAST SUBMISSION DATE:

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:

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For Related Documents:

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Announcement Date: 15-08-2019
Last Submission Date: 10-10-2019 02:00 PM

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