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Program Guidance

Investigator Sponsored Research Process Flow
  • The following diagram provides an overview of the ISR Process Flow and target timelines. Note: This diagram is focused on ISS studies and SCS studies may be longer.

    • ISR Process

    What types of support can be provided by ViiV?
    • ViiV support of approved proposals can be in the form of funding and/or study materials (including ViiV products or placebo)
    • In exceptional circumstances where the study requires a specialized capability to perform a specific activity (e.g. biomarker research) that the sponsor does not have and cannot feasibly retain an appropriate vendor; ViiV may perform the specific activity as part of ViiV’s support. Any ViiV funding for the study will reflect the fact that ViiV is providing this support.
    Is there an opportunity to collaborate on a study?
    Investigator Sponsored Research is research conducted by an external Sponsor with VH's support.

    There are three different ways VH can provide support:
    • Pure Substance Requests (PSR) are entirely designed and managed by an external Sponsor. VH can support in the form of supplying active pharmaceutical ingredient (API)/pure substance of VH product for HIV research purposes.
    • Investigator Sponsored Studies (ISS) are entirely designed and managed by an external Sponsor. VH can support in the form of funding and/or VH product. Specialized Capability support may be provided in exceptional circumstances, if capability is only available at VH. These studies are also known as Investigator-Initiated Studies, Investigator Initiated-Trials, Investigator Initiated Research or Investigator Sponsored Research.
    • Supported Collaborative Studies (SCS) are conducted by an external Sponsor, with VH contributing to study design and deliverables, in addition to the provision of funds and/or VH product. The level of collaboration from VH will vary from study to study and will be discussed through the proposal review process.

    In all circumstances the Sponsor of the research is accountable for all aspects of the study as well as for complying with all applicable ethical, regulatory, and legal requirements.

    If you are interested in collaborating, please include any additional support/capability required as part of your submission.
    How to apply for ISS/SCS support and what information is required as part of the submission?
    • VH reviews proposals aligned with VH’s Areas of Interest as they are received, working to the expected review timelines.
      • The exception is for Request For Proposals (RFP), which are released/reviewed at set points as identified by RFP.
    • Submit your study proposal by completing the online submission webform . You can access your submission at any time, however, once submitted, you cannot make any changes in the system.
    • You will be required to provide your CV and a detailed Budget template in case funding is requested as part of your submission.
    What happens after submission?
    • After submission, Sponsors receive an automatic e-mail notification from the system confirming that the proposal has been submitted successfully
    • Sponsors may be contacted by a VH representative (e.g., MSL) in case further information is required.
    • The following timings are subject to the submission being complete/all necessary documents received, in addition to complexity. Successful submission includes; VH proposal template, PI’s CV and the VH budget Tool (if applicable).
      • The initial assessment of a proposal's interest is based on its alignment with VH's Areas of Interest and strategic merit. VH is committed to getting back to all Sponsors on whether proposals/protocols are of strategic interest within 4 weeks of receiving all required documentation.
      • If proposal is of strategic interest, the proposal/protocol will then be reviewed by a cross-functional review for scientific merit, feasibility, and the quality of the proposal within 6 – 8 weeks of initial assessment completion.
      • The final decision to provide support is subject to a review and endorsement by VH Management within 6 weeks of Scientific review.
    The status of your proposal submissions can be viewed at any time and be available via logging in to "My proposals"
    How does VH assess whether a proposal is of strategic interest?
    The decision as to whether a proposal is of strategic interest is based on:
    • The importance and innovation of research objectives to medical science or patient care
    • Alignment with VH's current areas of interest
    How does VH assess during the scientific review?
    • The ability of the study Sponsor to deliver a high-quality ethical study
    • Scientific merit, quality of proposal and feasibility
    • If drug is requested, drug availability will be carried out
    • If funding is requested, a proportionate fair market value (FMV) analysis will be carried out.
    Although VH is more likely to support studies aligned to our current areas of interest for supported studies, we are interested in supporting studies that are innovative and contribute to scientific knowledge relating to medicine, medical condition or advancing a technology that supports human subject research. Full approval of the support is dependent upon the agreement of the protocol and signature of the legal agreement.
    What response will I receive?
    VH may get back to you before a decision is made in case further information is required. Once we have all the necessary information, we will review the proposal submissions as shown in the graphic above.

    VH commits that you will receive a response within 4 weeks, indicating either the proposal is of strategic interest, or it is not at this time (subject to receiving all required documentation).

    The proposal of strategic interest is an initial assessment, and it is not guarantee that studies will be supported.
    What are some best practices to facilitate the review process and ensure it runs smoothly?
    • At initial submission:
      • Submit a draft protocol instead of a proposal
      • Ensure all documents are submitted (CV, VH Budget Tool)
    • During Review Stage:
      • Respond to VH questions regarding your proposal in a timely manner (ideally within 72 hours)
    What will happen next if I hear back that the Proposal is approved?
    • We will ask you to produce the first draft of the full protocol within 12 weeks. Depending on the complexity of the protocol and agreement with VH this deadline can be increased.
      • If SCS, the protocol will be collaboratively developed with VH.
    • We will then progress to drafting and finalization of the legal agreement. VH has a legal agreement template that will be tailored with you to reflect the specific support being provided and expectations of both parties. Final approval to support a study is when the full protocol is accepted, and the legal agreement is signed.
    • Throughout the life of the study, the Sponsor is required to provide study progress reports and documentation as per the legal agreement.
    • Once the study is complete, the Sponsor is required to provide the final deliverables/publication as detailed in the legal agreement.
    What are the responsibilities of you as the Sponsor?
    Investigator Sponsored Studies are conducted independent of VH. The Sponsor of the research is accountable for all aspects of the study as well as for complying with all applicable ethical, regulatory and legal requirements.

    Responsibilities of the Sponsor include:
    • Develop the study proposal
    • Submit research proposal via the system, by completing all mandatory sections as per the forms on this site
    • Provide a Publication Plan as requested in the submission form including details around publications and posts to a worldwide public register for all human subject research
    • Produce the Protocol
    • To negotiate and execute a contract within 6 months of approval
    • Conduct high quality ethical study
    • Conduct the study within approved funding allocation and being accountable for managing drug supplies where applicable
    • Develop and maintain the case report forms
    • Initiate and monitor the study
    • Understand and comply with any and all pertinent laws, regulations, and guidelines
    • Understand and comply with any and all requirements of the institution(s) with which they are associated or at which research will occur
    • Meet applicable deadlines and all other requirements as defined in the legal agreement
    • Report safety data to regulatory authorities, the IRB/IEC (institutional review board, also known as an independent ethics committee), and VH as defined in the legal agreement
    • Provide updates on study progress to VH as defined in the legal agreement
    • Disclose any affiliation or financial conflicts of interest
    Any failure by the Sponsor to meet the above commitments may result in a decision by VH to cease supporting a Proposal, and VH may not support any subsequent proposals submitted by the Sponsor.
    What should the Sponsor expect of VH?
    • Review Proposals received and communicate within 4 weeks whether the Proposal is of interest.
    • A final decision on proposals of interest will be made within 18 weeks.
    • Provide approved support as outlined in the legal agreement in a timely manner.
    • Provide any scientific/medical feedback to the Sponsor at any point regarding the proposal, the Protocol, or any aspect of the study where VH has a concern about scientific integrity or patient well-being.
    • Timely responses to any inquiries or requests coming from the Sponsor, including decisions on completed Proposals.
    • Compliance with all applicable laws and regulations, including data protection laws with respect to the personal information of the sponsors/investigators.
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