Clinical Trial Management Systems

1. Clinical Trial Management Systems By Nageswararao. Y 1

2. Clinical Trial Systems – Key Application Areas Protocol Development Investigator/Site Selection and Trial Preparation Subject Identification and Enrollment Collection, Monitoring and Processing of Data Data Analysis and Reporting Safety and Adverse Event Reporting - Pharmacovigilance Submission for Review by Regulatory Authorities 2

3. Clinical Trial Systems – Stakeholders Protocol Development – Principal Investigator Trial Sponsor Investigator/Site Selection and Trial Preparation Sites Trial Sponsor IRB Subject Identification and Enrollment Sites Collection, Monitoring and Processing of Data Trial Sponsor Sites 3

4. Clinical Trial Systems – Stakeholders – Cont… Trial Management Trial Sponsor, Sites Data Analysis and Reporting Trial Sponsor Submission for Review by Regulatory Authorities Trial Sponsor to agency 4

5. Clinical Trial Systems – Technology Usage Protocol Development – Word Processing software such as Word, Adobe Document Management Solutions such as Documentum for organizing and standardizing the process of protocol development Protocol Authoring / Modeling tools Simulation software Investigator/Site Selection and Trial Preparation Excel Sheets In House Tracking systems to track receipt/ approvals of documents Internet based software systems 5

6. Clinical Trial Systems – Technology Usage – Cont … Subject Identification and Enrollment Media Advertisements Databases from local hospitals - Call centers Publicly available subject data from organizations such as Center Watch Collection, Monitoring and Processing of Data Clinical Data Management Systems (Paper based) Electronic Data Capture First Generation EDC tools OCR and OMR (Post Marketing Trials) Remote Data Entry IVRS (Interactive Voice Response Systems) 6

7. Clinical Trial Systems – Technology Usage – Cont… Second Generation EDC tools Integrated functionalities with much more clinical trial process functionalities Extensive usage of internet Hybrid systems with 2 modes of operations, online and offline Enhanced IVRS ePRO systems 7

8. Integrated CTMS Study Management Site Management Staff Management Supplies Management Adverse Event Reporting Medical Coding Subject Management Document Management Patient Diary Integration Monitoring Contracts Management Data Management Secure Offline and Online Capability Data Standards compatible LAB Data External Interfaces Regulatory Compliant Randomization 8

9. Alternative Views of CTMS systems 9

10. Clinical Trial Systems – Study Management A Program represents the top level in the grouping hierarchy of studies. Typically a Program is matched to a drug under investigation. Project maps to an indication or a formulation of the drug. Project is a collection of multiple studies. Assign multiple compounds to a program. Create a Program and the Projects associated with a Program 10

11. Clinical Trial Systems – Study Management – Cont … Organizational Unit defines the sponsors of a study Sponsor A Sponsor B Geographical Regions can be added to a study and one of them can be made as the Master geographical region United States (Master) India SriLanka Historical events may be one of two kinds: event recording triggered by the system, or a user-defined event Creation of this study Creation of a study version Setting or changing the randomization access codes for a study Setting or changing the study status 11

12. Clinical Trial Systems – Study Management – Cont … Set start and end dates for studies Set Study Objectives – A study can have more than one objective Set Enrollment Criteria – The list of criteria for including / excluding a subject in a trial Set Termination Criteria – The reasons for terminating a subject from a study Set Study Comment – Comments about the study Manage study design – One of the several clinical trial designs available to conduct a clinical trial 12

13. Clinical Trial Systems – Site/Investigator Management Create Sites Assign a site to a study Assign an investigator to a study site Link Patient positions to the site Maintain Investigator data Assign Treatments to a site Creating Strata and Randomization criteria Creating, Reviewing or Canceling blind breaks 13

14. Clinical Trial Systems – Treatments/ Events and Randomization Active Substances- Active substances are the New chemical entities which are being investigated Active Drug- The drug currently under investigation Treatment Regimen (A systematic Plan) defining the details about a drug’s dosing a single regimen is created combinations of single regimens is a Combination Regimen 14

15. Clinical Trial Systems – Treatments/ Events and Randomization Timelines, Periods, Sub periods and Phases Strata and Randomization strata means groupings of patients that have common characteristics; they are representations of particular expressions of factors. Randomization is the process of hiding patients’ treatments by assigning treatment patterns to patient positions in an unpredictable order Patient positions represent potential study participants Each factor describes a single characteristic, such as sex or age. 15

16. Clinical Trial Systems – Data Management 16

17. Clinical Data Management 17

18. Clinical Data Management 18

19. Study Management – Adverse Events 19

20. Clinical Trial Systems – Adverse Event Management Ability to enter and manage Adverse Events and Serious Adverse Event. Manage Adverse Event Discrepancy 20

21. Clinical Trial Systems – Oracle AERS 21

22. Clinical Trial Systems – Patient Diary Get Quality of Life Questionnaires filled by patients. Scheduled and Unscheduled entries - Send reminders to subjects, administer questionnaires, alert them for any invalid entries. Patient Compliance Tracking – Enables to track patient compliance by using date time stamps, edit checks and automatic scheduled reminders. Data can be secured and provide instant access to Investigators and Sponsors on a 24/7 basis. 22

23. Clinical Trial Systems – External data Import / Export data between clinical trial systems, AERS systems, Financial and ERP systems Can be CDISC or non CDISC based data transfer Operational Data can be typically split into Admin, Study, Subject, Audit trail sections LAB data can be transferred between LIMS and CTMS Adverse Event integration would happen with systems like Oracle Clinical Contracts and other financial data can be transferred from financial and ERP systems Inventory related information such as Supplies can be integrated with manufacturing controls 23

24. Clinical Trial Systems – External data – Cont … Randomization details could be integrated from IVRS based systems Contract details could also be retrieved from Document Management systems such as Documentum, ERP systems or Financial systems Document management systems like Documentum and Adobe can be integrated with CTMS easily. 24

25. References http://en.wikipedia.org/wiki/Clinical_Trial_Management_System http://www.medicalnewstoday.com/articles/60535.php http://www.microsoft.com/office/showcase/ctm/default.mspx 25

26. Thank you 26