Step-by-step workflows and intuitive design 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
Sites can automatically proceed through a clear timeline of activities, while startup managers can view activity completion in real time. Data from site visits and the feasibility survey flow into a custom workspace with flexible data sorting tools, enabling startup managers and sponsors to view the best information and make optimal decisions on site selection.
Invitation
Send email invitations and track completion.
CDA
Automatically proceed to a CDA for eSignature.
Study Synopsis
Gain access to a study synopsis for review.
Qualification Documents
Sites easily upload documents into placeholders.
Site Selection Visit
Schedule and track completion of pre-study visits.
Feasibility Questionnaire
Assign access to a versatile on-platform survey.
Site Selection Decision
Consolidate and assess data in a flexible workspace.
Site Activation
Startup managers can effectively guide a multitude of sites through a clear pathway of activation activities, with on-platform tracking, document collaboration and approvals. 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 documents into placeholders.
Sponsor Documents
Selectively distribute study 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.
