Site startup is one of the biggest causes of delays and difficulties in clinical trials, and a key area that has not benefitted from adequate system automation. TriPort Site Startup™ addresses this gap with a new, purpose-built platform that optimizes the startup process. TriPort Site Startup incorporates step-by-step workflows and intuitive design to make it easy for sponsors, CROs and sites to rapidly complete the full range of clinical study startup activities. Site startup managers and CRAs benefit from more effective tools, while senior-level sponsors gain a view of graphical metrics showing overall progress in selecting and activating sites.

Site Selection

Once engaged in study startup, sites can automatically proceed through a clear timeline of activities, while study startup managers can view activity completion in real time. Data from site visits and the feasibility survey flow into a custom study startup workspace with flexible data sorting tools, enabling study startup managers and sponsors to view the best information and make optimal decisions on site selection.

Invitation

Send emails inviting sites into study startup and track completion.

CDA

Automatically proceed on the TriPort Study Startup platform to a CDA for eSignature.

Study Synopsis

Gain access to a study synopsis to determine site interest in study startup.

Qualification Documents

Sites easily upload various study startup related documents into placeholders.

Site Selection Visit

Schedule and track completion of pre-study visits by CRAs supporting study startup.

Feasibility Questionnaire

Assign access to a versatile on-platform questionnaire to qualify sites for the study startup process.

Site Selection Decision

Consolidate and assess comprehensive study startup data for all sites in a flexible workspace.

Site Activation

Study startup managers can effectively guide a multitude of sites through a clear pathway of study startup activation activities, with on-platform tracking, document collaboration and approvals. Study startup milestone activities are configurable to match the plans for each study startup campaign.

Agreement and Budget

Collaborate with sites; track, accept and reject changes.

Form FDA 1572

On-system form completion, review and approval.

Site Documents

Sites easily upload study startup documents into placeholders.

Sponsor Documents

Selectively distribute study startup documents for eSignature.

IRB/EC Approval

Upload and confirm IRB/EC approval letters.

Site Staff Training

Training Center with slides, modules and certificates.

Site Initiation Visit

Schedule and confirm successful visit completion.

Activate Site

Review all requisites and promote sites to go-live.

Research Solutions

Related Resources