NOTICE

Request for Proposal (RFP)

Request for Proposal (RFP) Notice:
Clinical Research Organization (CRO) Support for diagnostic performance of Fragmentomics-based Methylation Analysis (FRAGMA) for the detection of lung cancer

Release Date: 26 March 2024
Contract Period: For a period of 60 months from the Date of Tender Acceptance or 6 July 2024, whichever is the later.
Closing Date and Time: 30 April 2024 at 12.00 noon (Hong Kong time)
  1. Project Overview
    The project aims to evaluate the use of non-invasive surveillance tool for the early detection of non-small cell lung cancer (NSCLC).
    The project is a multinational, multi-center study consisting of a total of 1,500 - 2,000 subjects.
    The study will be conducted across 6 sites located in different countries.

  2. Scope of Work
    The study will be conducted across 6 sites located in different countries. The specific scope of work is as followed:

    • Study start up
    • Clinical monitoring
    • Project management
    • Investigational product management
    • Data management
    • Statistical analysis
    • EDC
    • Sample distribution
    • Local CRO
  3. Criteria for Selecting Service Provider

    1. 3.1 Experience and Expertise
      The service provider should have a professional background with the relevant clinical research experience required for the project.
    2. 3.2 Quality Assurance and Compliance System
      The service provider should have a robust quality management system with high accuracy and reliability. The system should assist in quality assurance, compliance, documentation, auditing, data management, and reporting. The service provider should have excellent project management skills such as communication, planning, resource allocation, and time management to effectively progress the project.
    3. 3.3 Project Management Capability
      The service provider should have excellent project management skills such as communication, planning, resource allocation, and time management to effectively progress the project.
    4. 3.4 EDC and Data Management
      The service provider should be capable of customizing the EDC system and possess expertise in data management, data storage, data compliance, and related areas.
    5. 3.5 Pricing and Contract Terms
      The service provider should effectively communicate the cost structure, payment terms, scope of services, and delineation of responsibilities.
    6. 3.6 References and Reputation
      The service provider should have a favourable reputation (e.g. work quality, responsiveness, customer satisfaction).
    7. 3.7 Geographic Location and Resources
      The service provider should have a favourable geographical location and/or resources to carry out all required activities, along with local representatives or long-term partners in the selected countries. This includes equipment, technology, and human resources.
  4. Application Guidelines
    In preparing your proposal, please adhere to the instructions and conditions contained in this RFP. The following instructions and conditions are intended to assist you in the preparation and submission of a response to the RFP.

    1. 4.1 Please Submit the Proposal as Outlined Below:

      1. Cover Page
      2. Key Assumption
      3. Budget Summary
      4. Service Fee Breakdown — Global management
      5. Service Fee Breakdown — Regional Specific management
      6. Pass Through Fee Breakdown
      7. Payment Schedule 
    2. 4.2 Budget Submission and Site Cost Calculation Instructions:

      1. Submit the budget in a format that details the price per task as outlined in the Budget Summary, Service Fee Breakdown — Global management, Service Fee Breakdown — Regional Specific management and Pass Through Fee Breakdown. Estimated pass-through expenses are also required.
      2. The cost of each clinical site should be calculated separately.

All documents must be written in English and formatted in Microsoft Word or as a PDF.

For any inquired, please email to info@insighta.com.