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Please note: The ViiV ISS portal will be down for a system upgrade from Wednesday, November 14th from 12:00PM EST to Friday, November 16th 5:00PM EST. Please reach out to ops.visions@viivhealthcare.com for any questions or concerns during this time. We apologize for any inconvenience.
PSR

ViiV Healthcare Investigator-Sponsored Study (ISS)

ViiV Healthcare (VH) VH provides some form of support (product, funding, expertise*, specialized activities), but another entity is the Sponsor accountable for ALL aspects of the study.

Types of research eligible for support:

  • Interventional clinical studies (phase I-IV).
  • Non-interventional studies and studies using biological samples or data from previous studies (e.g. meta-analyses and pooled analyses, observational studies including epidemiology, methodology development and health outcomes studies).
  • Mathematical and health economic models.
  • Implementation Sciences Project (ISP).
  • In vitro or animal studies that include funding.**

In order to fully utilize this site, you must first register a profile. Once registered, you will be able to:

  • Submit a study high level “Concept” directly into VH’s ISS system, which will allow ViiV to determine if they are interested in this proposal and would like to have a full proposal submission.
  • Submit full study proposals directly into VH’s ISS system, which will facilitate more timely reviews and decisions.
  • Check on the status of both proposals and previously approved studies.
  • Post and receive electronic documentation directly through the system.
  • Receive periodic prompts regarding key milestones and deliverables associated with your proposals or previously approved studies.
*ISS expertise is limited to benefit/risk expertise related to the VH product in the study.
**Pure Substance requests that do not require funding should be submitted directly from the Pure Substance Request overview page.
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All Safety Reporting must be conducted as per your study agreement. If you need to report a suspected side effect for a ViiV Healthcare medicine that is not part of your study, please click the following.

Report a side effect

To report a suspected side effect, please use the online reporting form below. This facility is provided under our service agreement with GlaxoSmithKline (GSK), so please choose ‘ViiV Healthcare medicines’ from the drop-down product list on the form. In North America, you can report a side effect via the GSK Response Center at 1-888-825-5249, Monday-Friday, 8am - 8pm ET.

VH requires that all concepts are discussed with a VH representative BEFORE being entered in this portal

Start ISS Concept Proposal ➤
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