OpenQ

Navigate

Navigate IconNavigate is a full-featured solution for managing investigator initiated studies while ensuring regulatory compliance and maximizing your programs’ efficiency.Navigate  increases your efficiency while enhancing the visibility and value of your IIS programs.

Concerned about ensuring a compliant Investigator Initiated Study (IIS) Program? Worried about recent government investigations into IIS in your industry?Navigate  is the compliant solution that manages and automates the IIS process - from application, to documentation, to approval, to funding and auditing.

Users of Navigate will enjoy:

Business Process Efficiency – Navigate can be adapted to your business processes using its powerful workflow platform. Automate time-consuming, manual processes to decrease the time from submission to approval and activation. Ensure submission completeness using an on-line submission portal. Email-based notifications keep stakeholders up-to-date on required actions, such as approvals.

Objective Decision Justification – Complete audit trail of study reviews, decisions, and comments.Navigate  also records submissions and documentation, including version control.

Deep Program Insight – A powerful reporting engine turns recorded data into powerful and actionable insight. Track study financials – budget vs actual vs forecast. Analyze study and submission grouped by compound or therapeutic area. Measure key performance indicators for studies such as submissions received vs. approved, time from submission to approval, etc.

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