Below is a graphic depicting the typical organizational structure of a clinical trials operation and where the different versions of the software apply.

Data Manager - Manages all information in the system including Protocols, IRB Management, etc.  The purpose of the Data Manager version is to provide the ability to manage the Protocol and related IRB data centrally as well as produce the printed material for internal and Study Sponsor reporting.  This includes Protocol Amendments and Approvals, the Protocol Schedules and related data.  The Data Manager Version includes all the functionality of the Patient Manager too.  In short, the Data Manager can do everything available in the system where Patient Mgr only manages patient data and their Institution's IRB data.  Also, you can configure who has access to specific functionality.  For example, you can configure a specific Doctor (user) using the View Only version to HAVE or NOT HAVE the ability to Add Adverse Events for patients or Assign Patients to Protocols.

Features:

Ø      All Patient / IRB Manager and View Only functionality

Ø      Protocol creation including Protocol Schedules

Ø      Protocol Amendments recorded and initiated out to IRBs for approvals

Ø      Amendment approvals tracking and monitoring

Ø      IRB Annual Approvals monitoring

Ø      Document Management (paperless environment)

Ø      Financial data management, tracking and Reports

Ø      Test Result definitions including toxicity grading

Ø      Eligibility Criteria questions definition by Protocol

Ø      Protocol Selection hierarchical drill down specification

Ø      Custom and pre-configured Report generation

Ø      All Lookup table data maintenance

Ø      Manage Users and Roles assignment

Ø      Manage Licenses via License Manager

Patient/IRB Manager - Manages Patient/IRB data only, schedules, test results, Adverse Events, IRB Mgmt.  The Patient / IRB Manager version is intended to be used by the IRBs to manage their patients' and IRB data, rather than exchange printed documents with the central office / Data Mgr.  Also, internal personnel can use this version to manage patient info.  Since all the documentation (printed, fax, email, electronic documents, etc.) is stored in the Document Management System electronically, all the documents are shared with all users of the software.  No need to mail/FedEx/UPS/Fax paper any more.

 Features:

Ø      All View Only functionality

Ø      Add/Edit detailed Patient data

Ø      Assign Patients to Protocols available at your IRB

Ø      Manage Patient Schedules by Protocol including Unscheduled Events and Delays

Ø      Test Results data entry with toxicity tracking and remarks

Ø      Adverse Events entry and approvals functions

Ø      Protocol Amendments approvals processing

Ø      IRB Annual Approvals processing and tracking

Ø      Document Management (paperless environment)

View Only - Read only access (no updates) to all Protocol and Patient data.  The View Only version is used by Doctors and similar type users that only need to view Protocol and Patient data but optionally can have the ability to add Adverse Events, Assign Patients to Protocols (On Study) and take Eligibility Criteria Tests for patients.

 Features:

Ø      View Protocol, Patient and Schedule data

Ø      Eligibility Criteria Test completion

Ø      Adverse Events entry and review

Ø      Assign Patients to Protocols (optional)

Ø      View documents in Document Management (paperless environment)

As you can see, there is great potential for labor savings, reduced errors and a paperless environment using the Protocol Management System enabling you to handle more data volume with less effort.  Additionally all the data is shared and accessible from all versions of the software.  The software typically pays for itself in under one year.

 Contact us for Pricing, Demo and availability.