Collaborative Studies

ViiV Healthcare (VH) VH provides support and collaboration (product, funding, expertise*, input on protocol design, and specialized activities) for studies that are aligned to strategic priorities and where the benefits of the study justify the Collaboration which is not available in other types of ISR**. In these studies VH will NOT be the study sponsor, another entity will be the Sponsor and be 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). (See Implementation Science Proposal Guidance for additional information.)

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

• Submit a study proposal form directly into VH’s ISS system, which will initiate the ViiV review process. Note: For proposals involving Implementation Science please review the Implementation Science Proposal Guidance in the toolbox before submitting the proposal.
• Invite additional users and provide shared access to the system information and collaborate on the proposal/study.
• Check on the status of both current 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.

*Expertise allowed for Supported Collaborative Studies is broader than that available for other types of ISR. The expertise may include collaboration on the proposal, study design, and the study protocol. However, this additional support will not include assuming accountability for items that are the responsibility of the sponsor.

**Normal Investigator Sponsored Studies that involve funding and or drug support and Pure Substance requests that do not require funding should be submitted to the ISS or PSR request pages.

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