Categories include:

2. The most ambitious, prolific and progressive software solution available for Clinical Trails is a customized, complete, end-to-end, EDC / CTMS / Randomization Plus application aptly named • Simplicity. • Developed by Software Dynamics, Simplicity was designed with in-depth aid and input from ENLIGHTEN, INC.in order to become the most all-inclusive, fully-comprehensive, highly-customizable application of its kind anywhere in the world.

3. With Simplicity, clinical trial management is made easy by integrating dynamic composition, intuitive architecture, multi-layered security and real-time reporting for convenience, convergence and compliance.

4. The primary and unrivaled feature of Simplicity’s architecture is the flexibility it offers to all potential users. Simply put, potential users have the option of utilizing Simplicity in the form of a client server, computer-based application OR in the form of an application server, internet-based application.

5. Additionally, the architecture that supports Simplicity is packed with cutting edge features that ensure data loss is all but impossible and thus, virtually a thing of the past.

6. The basic layout includes dual servers, each with Raid 10 redundancy, an off-site local daily backup to a mass storage server, and weekly off-site media storage on digital CD/DVD or Tape.

7. If desired, an additional secondary server housed in a secure, remote location can also be included with any system configuration.

8. Following initial password authorization, Simplicity greets each individual user with an Alerts and Announcements page that highlights any activity that might require immediate attention.

9. Categories include: • Email, Queries, Adverse Events, Serious Adverse Events, Protocol Deviations and PI Signature Files. Additionally, Sponsors can communicate with users on this page through the announcement box.

10. Additionally, access to the live network requires a user-unique electronic signature accompanied by a constantly changing encrypted pass code. Such strict measures secure Simplicity to the extent equivalent to that of a virtually impenetrable global internet banking system.

11. One of many user-friendly aspects of Simplicity is a protocol-specific schedule of assessments on each and every page within Simplicity accessible to all users.

12. An example Schedule page from Simplicity.

13. Unlike the formats of most other EDC systems on the market today, the Simplicity format for Case Report Forms was designed to emulate paper Case Report Forms as demonstrated by this Screening Visit page. Thus, making the transition from paper or another EDC system to Simplicity is easy and intuitive.

14. This design technique was fueled by the understanding that all CRF entries are divided into just two basic categories: • Visits • and • Events

15. Visits being the actual occurrence of a subject’s on-site participation in a clinical trial. • Events being anything that can happen during such visits.

16. An example Screening page from Simplicity.

17. Another user-friendly, fool-proof aspect of Simplicity is that it prompts each individual user to enter the correct information at each stage of the documentation or reporting process.

18. Whenever a system entry or alert message indicates that a special form or additional information is deemed necessary for purposes of protocol compliance or adherence to Good Clinical Practices, Simplicity responds by prompting the user to complete the appropriate form and suggests a procedure to follow with regard to submission of such forms.

19. For example, if inclusion or exclusion criteria are violated during the screening process at a particular site, then Simplicity automatically alerts all users with access to that site of the violation.

20. Subsequently, the system prompts the study coordinator to document the protocol violation and complete a protocol exemption request that, when completed and submitted, is forwarded to project management for approval.

21. An example Protocol Exemption Request page from Simplicity.

22. Upon successful completion of Screening, Simplicity’s patent, fully-electronic Randomization Plus feature avoids the typical IVRS hassle of extraneous, lengthy telephone calls and less than optimal, non-comprehensive internet applications…And, at no additional cost.

23. The application’s protocol-specific, custom-generated algorithm enables error-free, swift stratification of subjects into appropriate randomization arms. In doing so, the system allocates the appropriate investigational product to each subject given the arm to which they are randomized.

24. Furthermore, the system maintains an ongoing account of each subject’s dispensed and return investigational product while also calculating their percentage of compliance with the protocol.

25. Lastly, all investigational product inventory and tracking information including: shipping invoices and recipient records are maintained in real time. Thus, all records are instantly available to all users 24/7/365.

26. An example Randomization page from Simplicity.

27. During both scheduled and unscheduled visits, responses that require additional information to be documented prompt the study coordinator to document such information on the appropriate form in order to maintain GCPs and adherence to protocol-specific CRF Completion Guidelines.

28. During the standard visit page pictured here, the user is prompted to document a new AE due to recording a change in medical condition that occurred during this visit.

29. An example Visit page from Simplicity.

30. When prompted by the system to document a new AE, the study coordinator may choose to: • Document the event at that precise moment • - or - • Proceed without documenting the event; which will cause the system to generate an automatic query.

31. The selection made in this example was to record the adverse event. In doing so, the event was also documented as meeting serious criteria.

32. Such documentation further prompts the study coordinator to complete and submit an SAE report form to Project Management and, if parameters are set forth by a specific client, to the site’s Institutional Review Board.

33. An example New AE page from Simplicity.

34. The SAE report form generated by Simplicity is completely proprietary and was designed to exceed even the most stringent requirements set forth in the FDA Code of Federal Regulations and ICH Guidelines.

35. Additionally, the customizability of Simplicity allows for any form, SAE report or otherwise, to be adapted and implemented into the system for protocol-specific use by each individual client.

36. An example SAE Report page from Simplicity.

37. Simplicity makes the usually cumbersome task of Source Document Verification efficient and easy. Any new CRF page that is being documented appears as a new window and clearly pre-labels each required entry.

38. Items that require SDV for each particular CRF page can be marked off individually or collectively by checking the “Select All” box as shown here.

39. In cases where a CRF page has been partially documented, but not completed, the page will appear as a tabbed entry rather than in a new window. Page editing is easily accomplished in this scenario by simply checking the appropriate boxes pertaining to tasks recently source verified and selecting the “Update” button.

40. In the interest of creating a historic document for audit purposes, any and all modifications to the SDV pages are identified with the user’s name, as well as the date and time of each modification.

41. An example SDV page from Simplicity.

42. At each client’s discretion, Simplicity can designate that certain items such as: Protocol Exemption Requests, Protocol Violations, Protocol Deviations, AEs and SAEs are officially acknowledged when witnessed by users of the system with appropriate permission levels.

43. This applies to Investigators, Monitors, and Project Management alike. The determination of which items should require acknowledgement is protocol and client-specific. The application is custom-tailored to meet these parameters.

44. An example Monitor Acknowledgment page from Simplicity.

45. Query generation and resolution has been greatly uncomplicated by Simplicity. All query-related data is live and allows queries to be generated, addressed, and resolved in a matter of minutes from literally any location in the world.

46. The Query Resolution Summary page shown here allows the monitor to view queries in the system by individual site or collectively for all sites to which the monitor is assigned.

47. This page also maintains a cumulative record of query resolution efficiency for each site and each monitor.

48. Since Simplicity was designed to be a complete Clinical Trial Management System, the optional Administration module enables Sponsors to fully manage a clinical trial with a single application.

49. Various aspects of this module include access to the protocol from any page within Simplicity, pre-formatted, protocol-specific letters, contact lists, and SOPs.

50. It also includes a full Monitor Reporting system that utilizes pre-formatted, protocol-specific report templates. These reports may be completed by the monitor, submitted to and reviewed by Project Management all electronically and all in real time.