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The smarter, faster way to
   start your clinical study on the web

                                      Starting a clinical trial? You probably track site and country activation tasks
HIGHLIGHTS
•	 Predict progress more accurately   and documents using a clunky spreadsheet, expensive 3rd-party application,
•	 Drive business decisions with      or cumbersome internal solution. Why is it so easy to book travel or purchase
   actionable metrics
                                      movie tickets online, yet we settle for complex, confusing, and overpriced
•	 Identify bottlenecks
                                      eClinical solutions? Not any more.
•	 Get local flexibility and global
   standardization of progress data
                                      Introducing Tracker 2.0                        Reports and metrics provide
•	 Intelligent, customizeable
   workflows                          Tracker is the cloud-based software-as-        actionable data to improve efficiency
•	 Realtime status at a glance        a-service (SaaS) application that gives        Tracker records when each task starts
                                      sponsors, CROs, and sites anytime,             and completes. Set baseline dates for any
•	 Adjust resources quickly           anywhere access to study startup status,       milestone, then compare them against
•	 Get up and running in days         metrics, and data.                             actuals to measure and manage team
                                                                                     performance. No need to compile status
•	 Access study data 	
                                                                                     reports — now everyone sees real-time
   anytime, anywhere                  Workflows reflect your SOPs
                                                                                     study progress on their Tracker dashboard.
•	 Built with usability in mind       Tracker’s workflows guide study teams
                                      to complete and track the specific
                                      documents and tasks required for any
                                      site, country, or study based your SOPs.
                                      If your requirements change, just update
                                      Tracker’s workflows accordingly. Our
                                      new workflow wizard helps you choose
                                      the right workflow to create the required
                                      activities for the right countries or sites.


                                      To-do lists guide the work

                                      When it’s time to complete an activity,
                                      Tracker displays it on your to-do list. See
                                      to-dos for today or later, for you or your
                                      entire study team.




tracker2_datasheet_13FEBV2013_v1
                                                                                          1
datasheet                                                       author


             Smart     •	 Customize workflows to reflect your SOPs                                  prep & send
     customizeable
                       •	 Create workflows for local and global tracking requirements
         processes                                                                                                                   approved
                                                                                                                            review
                       •	 Re-use workflows for other studies

                       •	 Change workflows as requirements change                                                rejected
                                                                                                                                          accept
                       •	 You aren’t asked to perform an activity until all pre-requisites are met (Dependencies)

                       •	 Workflow wizard helps you run the right workflows

                       •	 Assign team members to manage tasks, one-at-a-time or in bulk

                       •	 Specify requirements and key dates for each competent authority or ethics committee

                       •	 Record notes about sites, documents, and submissions then save them as part of a site
                          or country record

                       •	 Manage protocol amendments

                       •	 Manage study and site documents for convenient anytime, anywhere access

                       •	 Enter a document location to indicate where documents are stored on a shared drive or other repository

        Actionable     •	 The entire study team sees study status on their Tracker dashboard
 reports & metrics     •	 Gain new metrics and insights into your study team’s performance by tracking tasks and
                          completion times for each activity

                       •	 Visual timelines, charts, and graphs help you quickly determine status and milestones

                       •	 Study country and site timelines show baseline, projected, and actuals dates for key global milestones

                       •	 Interactive report shows global status and allows you to drill down into the details

                       •	 Generate reports to print or export to a spreadsheet

                       •	 Entire startup history is consolidated and accessible by the
                          entire study team
                       •	 See at a glance which activities haven’t started, are
                          in-progress, or activated

                       •	 Study status updates in realtime as activities start
                          and complete

                       •	 See documents required for each country and site

                       •	 See all activities in one, convenient place

                       •	 See at a glance which team members are assigned to a site or country

         To-do lists   •	 To-do lists help organize the work and let you know when it’s time to take action

          Safety &     •	 Built using a software development process that helps you meet
        compliance
                       •	 21 CFR Part 11 requirements

                       • Full audit trails and traceability
                       •	

                       •	 Data backed up daily




                       Call, email, or visit us
           address:    351 California Street, Suite 1450 | San Francisco, CA 94104 USA

           phone:      415.671.4372 or 877.230.4168 (7am-5pm PST, M-F)

           email:      info@gobalto.com                 web: www.gobalto.com/tracker

tracker2_datasheet_13FEBV2013_v1
                                                                                                      2

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The smarter way to start your clinical study

  • 1. The smarter, faster way to start your clinical study on the web Starting a clinical trial? You probably track site and country activation tasks HIGHLIGHTS • Predict progress more accurately and documents using a clunky spreadsheet, expensive 3rd-party application, • Drive business decisions with or cumbersome internal solution. Why is it so easy to book travel or purchase actionable metrics movie tickets online, yet we settle for complex, confusing, and overpriced • Identify bottlenecks eClinical solutions? Not any more. • Get local flexibility and global standardization of progress data Introducing Tracker 2.0 Reports and metrics provide • Intelligent, customizeable workflows Tracker is the cloud-based software-as- actionable data to improve efficiency • Realtime status at a glance a-service (SaaS) application that gives Tracker records when each task starts sponsors, CROs, and sites anytime, and completes. Set baseline dates for any • Adjust resources quickly anywhere access to study startup status, milestone, then compare them against • Get up and running in days metrics, and data. actuals to measure and manage team performance. No need to compile status • Access study data reports — now everyone sees real-time anytime, anywhere Workflows reflect your SOPs study progress on their Tracker dashboard. • Built with usability in mind Tracker’s workflows guide study teams to complete and track the specific documents and tasks required for any site, country, or study based your SOPs. If your requirements change, just update Tracker’s workflows accordingly. Our new workflow wizard helps you choose the right workflow to create the required activities for the right countries or sites. To-do lists guide the work When it’s time to complete an activity, Tracker displays it on your to-do list. See to-dos for today or later, for you or your entire study team. tracker2_datasheet_13FEBV2013_v1 1
  • 2. datasheet author Smart • Customize workflows to reflect your SOPs prep & send customizeable • Create workflows for local and global tracking requirements processes approved review • Re-use workflows for other studies • Change workflows as requirements change rejected accept • You aren’t asked to perform an activity until all pre-requisites are met (Dependencies) • Workflow wizard helps you run the right workflows • Assign team members to manage tasks, one-at-a-time or in bulk • Specify requirements and key dates for each competent authority or ethics committee • Record notes about sites, documents, and submissions then save them as part of a site or country record • Manage protocol amendments • Manage study and site documents for convenient anytime, anywhere access • Enter a document location to indicate where documents are stored on a shared drive or other repository Actionable • The entire study team sees study status on their Tracker dashboard reports & metrics • Gain new metrics and insights into your study team’s performance by tracking tasks and completion times for each activity • Visual timelines, charts, and graphs help you quickly determine status and milestones • Study country and site timelines show baseline, projected, and actuals dates for key global milestones • Interactive report shows global status and allows you to drill down into the details • Generate reports to print or export to a spreadsheet • Entire startup history is consolidated and accessible by the entire study team • See at a glance which activities haven’t started, are in-progress, or activated • Study status updates in realtime as activities start and complete • See documents required for each country and site • See all activities in one, convenient place • See at a glance which team members are assigned to a site or country To-do lists • To-do lists help organize the work and let you know when it’s time to take action Safety & • Built using a software development process that helps you meet compliance • 21 CFR Part 11 requirements • Full audit trails and traceability • • Data backed up daily Call, email, or visit us address: 351 California Street, Suite 1450 | San Francisco, CA 94104 USA phone: 415.671.4372 or 877.230.4168 (7am-5pm PST, M-F) email: info@gobalto.com web: www.gobalto.com/tracker tracker2_datasheet_13FEBV2013_v1 2