FAQs

1. What does CRIX stand for?
   CRIX stands for Clinical Research Information eXchange.
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2. What is CRIX International?
   CRIX International is a not-for-profit organization formed by industry leaders and standards organizations to realize the vision of a shared clinical information exchange.
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3. Who is the CRIX Community?
   The CRIX Community includes patients and patient advocates, hospital groups, academic research centers, biopharmaceutical companies, trade and standards-setting organizations, contract research organizations, and industry service providers.
   The CRIX Community is open to everyone involved in clinical research and the development of new therapies and products that improve health and quality of life. Individuals and organizations can become part of the CRIX Community.
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4. What is an information exchange?
   An information exchange consists of a secure, standards-based information platform coupled with low-cost tools designed to support research business processes. Such an exchange will act as a hub capable of receiving, storing, and sending regulated information, with spokes that can reach out to anyone interested in biopharmaceutical research or products.
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5. What is the need for an information exchange?
   Currently, the parties involved in clinical research exchange information through a series of one-to-one connections. The result is siloed information and redundant investments in technology. CRIX will consolidate those investments, freeing time and resources for clinical research.
   With the entire clinical research community- patients, patient advocates, hospital groups, academic research centers, sponsors of new therapies, and health authorities-connected through this exchange, CRIX represents a more efficient model for information sharing. The broad adoption of such an exchange will create a shared knowledge base, increased opportunities for collaboration, and the efficiencies of scale afforded through centralization.
   Ultimately, these shared services will allow for the speedier delivery of improved medical therapies to patients.
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6. What is CRIX International's role in the delivery of an information exchange?
   We are a neutral, not-for-profit organization that will oversee and govern the operation of an information exchange. As part of that oversight, we will also promote innovation for the information exchange on behalf of the CRIX Community. The division of governance and operations lends itself to participation by both public and private stakeholders without conflict of interest, to the benefit of the entire community.
   
   As a neutral entity, we are focused on the following four sets of activities:
   • Governance of the information exchange
   • Oversight of the development, management, and maintenance of the information exchange
   • Evaluation and incubation of potential new services of interest or benefit to the CRIX Community
   • Promotion of the exchange for use across the CRIX Community.
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7. What is the governance structure of CRIX International?
   Our governance structure is built on four foundational elements:
   • A Board of Directors that, by charter, will include a broad range of industry participants. The Board will eventually be comprised of representatives from US and international regulatory agencies, standards organizations, pharmaceutical companies, patient advocate organizations and clinical research organizations. The Board is responsible for setting and approving CRIX strategy and objectives, as well as providing oversight to the Management Team.
   • The Management Team provide day-to-day operational oversight of the platform to ensure that services delivered by third-party vendors meet the security requirements and standards required by all users of the platform.
   • Regional Advisory Councils that allow a cross-section of the CRIX Community to participate in our activities. Members of these councils represent their stakeholder groups and provide expertise into the conceptualization, planning, and execution of CRIX International initiatives.
     • The North American Advisory Council (NAAC) includes representatives from large pharmaceutical companies, small bio-techs, patient advocates, healthcare-related non-profit organizations and clinical research organizations. These members represent the business and research requirements for activities in North America.
     • The European Advisory Council (EAC) launch has been planned to include a similar group of representatives to guide CRIX in matters of importance for research in Europe
     • The Emerging Regions Advisory Council (ERAC) will be planned to include advisors from areas of the world that are of emerging importance to the global research community. These areas include South America, Eastern Europe and continental Asia.
   • Special Interest Groups that will provide subject matter expertise, feedback, and technical advice in specific areas, such as clinical operations, product safety, or public interest.
   Regulatory agencies will have an opportunity to participate at all levels of the CRIX organizational structure. Seats on the Board of Directors have been specifically reserved for both US and international regulatory agencies. We encourage the involvement of regulatory agencies in each of our planned advisory councils to provide needed input to prioritization of potential services. Finally, we expect routine interaction at the management level with regulatory agencies to discuss operational issues as they arise.
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8. What is CRIX International's role in service delivery?
   As the governing body for the exchange, we will establish the standards and operational framework for the exchange and its services, and engage third-party vendors in the development and delivery of both through an open, transparent Request for Proposal process.
   
   We will work closely with the Community to identify their most valuable, urgent, and requested services, to define requirements, and to monitor the quality of these services once available.
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9. What is the process for identification, prioritization, and development of new services?
   We have implemented the StageGate® methodology for reviewing areas of potential service, organizing analysis, and prioritizing services. The process is as follows:
   • We will actively engage the CRIX Community via our Regional Advisory Councils and Special Interest Groups to determine priorities for services. These priorities are based on public health benefits, business need, and market and regulatory challenges.
   • Based on their recommendations, the Management Team will collaborate with the Community to develop a more detailed business case for the service in question. The Management Team will include appropriate analysis of value, market solutions, costs for development, and operations requirements.
   • Where required, the Management Team may engage a partner to prototype a solution or conduct a proof-of-concept to gauge viability and/or cost of delivery of the solution.
   • The Management Team will analyze this business case and prepare a presentation and recommendation to the Board of Directors for action.
   • The Board of Directors will review the business case and recommendations to make a final determination regarding service deployment.
   • If the Board approves the identified service, the Management Team will create a formal Request for Proposal and manage a competitive evaluation process for the development and deployment of the service among third-party vendors.
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10. How will CRIX International gather requirements for services in development?
    Our process for gathering requirements from the CRIX Community is documented in the CRIX Product Management and Development plan, which is available upon request. This process includes:
    • Open solicitation and invitation to participate in the Special Interest Group for the service.
    • Establishment of a public web area for the exchange of documents, e-mail distribution, and collaboration by the group with open, anonymous registration.
    • Regularly scheduled conference calls with this group to discuss discreet areas of functionality, addressing the solution in manageable components.
    • Catalogue of business use cases and requirements in an electronic analysis tool which supports:
      • Versioning of requirements
      • History of revision
      • Association of requirements with specific releases
      • Generation of test cases
      This tool will be made available via web interface to our user groups in 4Q07 to allow online review and comment of requirements for CRIX business components
    • Review of a service prototype by the Special Interest Group to ensure that the requirements documented are properly interpreted and understood by us.
    • Following the prototype review, we use a documented Software Development Lifecycle to build the functioning service with iterative review sessions with the Special Interest Group. This approach increases user acceptance of the final product and ensures that the delivered software meets user group expectations.