Study 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 Study Startup™ addresses this gap with a new, purpose-built platform that optimizes the startup process. TriPort Study 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. Study 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.
