The Use of Electronic Systemsin Early Phase Clinical Trials for   Ensuring GCP Compliance         Mr. Vinoth Kumar T  Assi...
Disclaimer•   The views and opinions expressed in the following PowerPoint slides are those    of the individual presenter...
Agenda•   Characteristics & Overall Process of Early Phase Studies•   Issues & Reasons for GCP Non-compliance in Early Pha...
Characteristics of Early Phase Studies •   Includes Phase 0 to Phase IIa Clinical Trials •   Conducted through volunteer r...
Characteristics of Early Phase Studies •   Trial activities require various critical sample collection,     aliquoting, pa...
Overall Process of Early Phase Clinical Trials                                             Volunteer enrollment          ...
Issues & Reasons for                            GCP non-compliance                           in Early Phase Studies6th Ann...
Issues of GCP compliance in Early Phase Studies          GCP INSPECTIONS METRICS REPORT - Phase I Clinical Units   6th Ann...
Issues of GCP compliance in Early Phase Studies   Major Non – Compliance issues occurred during :      Volunteer Identific...
Error Sources for GCP Non – Compliance    Lack of GCP guidelines knowledge    Lack of a consolidated study information dat...
Potential Electronic Systems for                  Early Phase Clinical Units6th Annual Conference on Global Drug Developme...
Why use Electronic Systems ?To Improve & Increase …..          SPEED                             EFFICIENCY               ...
Potential Electronic Systems for Early Phase Clinics              Tablet PC and Personal Digital Assistant (PDA)         ...
Potential Electronic Systems for Early Phase Clinical Units                                                            Ear...
Electronic Systems in Early Phase Clinical Trials  Volunteer                               Volunteer                      ...
Significance of Barcodes in Early Phase Studies     Favors informed decision making     Generates trial specific error ale...
Electronic Systems in Early Phase Clinical Trials    Study                                  Query                         ...
1. Electronically Automated Process - Volunteer Recruitment                                         Volunteer Screening Fo...
2. Electronically Automated Process - Study Start Up        Document                Configure wireless Network in the clin...
3. Electronically Automated Process - Study Conduct                        Record trial data using Bedside Medical Devices...
4. Electronically Automated Process - Study Closure                                       Database          Quality       ...
4. Electronically Automated Process - Study Report SubmissionCentralized Study Database             Prepare Study data in ...
Benefits of using Electronic Systems           in Early Phase Clinical Studies6th Annual Conference on Global Drug Develop...
Benefits of using Electronic Systems   Sensitive audit trail  Increased GCP Regulatory Compliance,   lesser audit queries...
Benefits of using Electronic Systems   Centralized Study Database  Integration of data from   different instruments and d...
Electronic Systems Implementation              Considerations & Overall Plan6th Annual Conference on Global Drug Developme...
Considerations in the use of Electronic Systems      21 CFR Part 11 Compliant      Accurate, complete, timely, verifiable ...
Electronic Systems – Implementation Plan Items                              • Perform exhaustive vendor analysis          ...
Implementing Electronic Systems in Clinical Units     Strategize                  Design               Transition         ...
Summary Early Phase Clinical Studies involve time-based complex clinical assessments with the additional constraints of vo...
Conclusion          Thank You for your attention ! For further information, assistance & queries you are most welcome to c...
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The Use of electronic systems in early phase clinical studies for ensuring GCP compliance - Vinoth Kumar T

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This presentation describes the potential use of electronic systems to increase GCP compliance during the conduct of early phase clinical trials. It also speaks about the benefits and the considerations of 21 CFR Part 11 compliance while choosing and implementing electronic systems in clinical trial units.

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The Use of electronic systems in early phase clinical studies for ensuring GCP compliance - Vinoth Kumar T

  1. 1. The Use of Electronic Systemsin Early Phase Clinical Trials for Ensuring GCP Compliance Mr. Vinoth Kumar T Assistant Manager – Delivery Lead (E-Clinical Technologies) Interpreting Life Sciences Solutions
  2. 2. Disclaimer• The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. (“DIA”), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated.• These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners. 6th Annual Conference on Global Drug Development and Market Access October 15-18, 2011 | Mumbai, India
  3. 3. Agenda• Characteristics & Overall Process of Early Phase Studies• Issues & Reasons for GCP Non-compliance in Early Phase Studies• Potential Electronic Systems for Early Phase Clinical Units• Benefits of using Electronic Systems in Early Phase Clinical Studies• Electronic Systems Implementation Considerations• Summary 6th Annual Conference on Global Drug Development and Market Access October 15-18, 2011 | Mumbai, India
  4. 4. Characteristics of Early Phase Studies • Includes Phase 0 to Phase IIa Clinical Trials • Conducted through volunteer recruitment and constant bedside monitoring • Protocol requirements include time dependent clinical pharmacology assessments (PK/PD, SAD, MAD Tests) 6th Annual Conference on Global Drug Development and Market Access October 15-18, 2011 | Mumbai, India
  5. 5. Characteristics of Early Phase Studies • Trial activities require various critical sample collection, aliquoting, packaging and shipment procedures • A labor intensive process involving regular daily communication different personnel teams • Overall these studies require meticulous planning, monitoring and governance 6th Annual Conference on Global Drug Development and Market Access October 15-18, 2011 | Mumbai, India
  6. 6. Overall Process of Early Phase Clinical Trials  Volunteer enrollment VOLUNTEER  Volunteer participation history tracking RECRUITMENT  Volunteer screening  Volunteer recruitment  Study specific Labels creation STUDY  Designing of Paper CRF/ e-CRF STARTUP  Study IP and sample Inventory Tracking & Management  Complex clinical pharmacology assessments  Record trial data Entry  Generate and manage queries online and off-line STUDY  CRA Monitoring CONDUCT  Sample collection, aliquoting & Shipment  Environment and IP Management  Immediate reporting of AE and SAE’s  Resolve and close all queries STUDY  Consolidation of all external and internal study reports CLOSURE  Drug Accountability and Safety Reconciliation  Preparation & Submission of Final Study Report 6th Annual Conference on Global Drug Development and Market Access October 15-18, 2011 | Mumbai, India
  7. 7. Issues & Reasons for GCP non-compliance in Early Phase Studies6th Annual Conference on Global Drug Development and Market AccessOctober 15-18, 2011 | Mumbai, India
  8. 8. Issues of GCP compliance in Early Phase Studies GCP INSPECTIONS METRICS REPORT - Phase I Clinical Units 6th Annual Conference on Global Drug Development and Market Access October 15-18, 2011 | Mumbai, India
  9. 9. Issues of GCP compliance in Early Phase Studies Major Non – Compliance issues occurred during : Volunteer Identification & Recruitment Investigator Procedures in Early Phase Trials IMP Dispensing & Management Source Data Verification Study Documentation 6th Annual Conference on Global Drug Development and Market Access October 15-18, 2011 | Mumbai, India
  10. 10. Error Sources for GCP Non – Compliance Lack of GCP guidelines knowledge Lack of a consolidated study information database Lack of critical study procedure warnings and reminder alerts Absence of end to end tracking facility for all trial activities Manual preparation of study procedure labels Lack of Real time Data Availability & Safety Reporting Lack of a controlled Document Management system Lack of automated facility for environment monitoring 6th Annual Conference on Global Drug Development and Market Access October 15-18, 2011 | Mumbai, India
  11. 11. Potential Electronic Systems for Early Phase Clinical Units6th Annual Conference on Global Drug Development and Market AccessOctober 15-18, 2011 | Mumbai, India
  12. 12. Why use Electronic Systems ?To Improve & Increase ….. SPEED EFFICIENCY COMPLIANCE • Achieved through • Achieved by device & • Achieved with the Automation apps Integration sensitive Audit Trail • Increased by Real time • Better Process Control • Errors minimized Data Availability • Proactive organizational through alerts and Communication warnings Increase Value Proposition of the Organization 6th Annual Conference on Global Drug Development and Market Access October 15-18, 2011 | Mumbai, India
  13. 13. Potential Electronic Systems for Early Phase Clinics  Tablet PC and Personal Digital Assistant (PDA)  Medical Devices (Pulse Oximeters, Glucometers, Spirometers)  Barcode Generator and Scanner (1D, 2D and 3D Barcodes)  Biometric Devices (Finger printing, Retina scan etc.)  Integrated Environment Sensors  Bluetooth Mobile devices  Centralized EDC Application - IVRS  Document Management Systems for e-Submissions  Wireless Network Technologies (SMS, E-mail) 6th Annual Conference on Global Drug Development and Market Access October 15-18, 2011 | Mumbai, India
  14. 14. Potential Electronic Systems for Early Phase Clinical Units Early Phase Clinical Trial Electronic Devices 6th Annual Conference on Global Drug Development and Market Access October 15-18, 2011 | Mumbai, India
  15. 15. Electronic Systems in Early Phase Clinical Trials Volunteer Volunteer Clinical Verification Recruitment Study Setup 6th Annual Conference on Global Drug Development and Market Access October 15-18, 2011 | Mumbai, India
  16. 16. Significance of Barcodes in Early Phase Studies Favors informed decision making Generates trial specific error alerts and warning messages Helps in tracking time taken for completing a medication procedure Transcribes sensitive information in a machine readable format – Thus maintains confidentiality & data security 2D Barcodes can also store email IDs, hyperlinks, Phone numbers, pictures, SMS/MMS and Calendar Entries 6th Annual Conference on Global Drug Development and Market Access October 15-18, 2011 | Mumbai, India
  17. 17. Electronic Systems in Early Phase Clinical Trials Study Query Study Conduct Management Closure 6th Annual Conference on Global Drug Development and Market Access October 15-18, 2011 | Mumbai, India
  18. 18. 1. Electronically Automated Process - Volunteer Recruitment Volunteer Screening Form Volunteer Enrollment Volunteer Biometrics Centralized Study Database Telephone ScreeningVolunteer Barcode ID & Volunteer Online Data Entry Volunteer ScreeningWristband Label Generation Database 6th Annual Conference on Global Drug Development and Market Access October 15-18, 2011 | Mumbai, India
  19. 19. 2. Electronically Automated Process - Study Start Up Document Configure wireless Network in the clinic ward Print volunteer linked Management System Clinical Sample Labels Stick & scan Sample Barcode Labels / Volunteer Centralized Study Database Sample vessel allocated / volunteer Setup Freezer, Study E – CRF Sample storage Perform Environmental Design & Edit Checks & Ward Temperature Alerts Monitoring Programming 6th Annual Conference on Global Drug Development and Market Access October 15-18, 2011 | Mumbai, India
  20. 20. 3. Electronically Automated Process - Study Conduct Record trial data using Bedside Medical Devices Record Volunteer Clinical Sample Collection Time Scan Sample Barcode Labels / Volunteer Centralized Study Database CRA Monitoring Instant Online QueriesSensitive Lab Instruments Blinding, Randomization, Time alerts and warnings during E-CRF & Temperature Alerts IP Dispensing & Tracking on Mobiles and PDA’s Data Entry on Tablet PC 6th Annual Conference on Global Drug Development and Market Access October 15-18, 2011 | Mumbai, India
  21. 21. 4. Electronically Automated Process - Study Closure Database Quality Study Queries Drug Accountability Lock Control resolvedCentralized Study Database Drug Safety Database Final Study Reports Volunteer Trial participation Tracked Written on to CDs for regulatory submission Study Documents Tracking & Archival Volunteer Exit 6th Annual Conference on Global Drug Development and Market Access October 15-18, 2011 | Mumbai, India
  22. 22. 4. Electronically Automated Process - Study Report SubmissionCentralized Study Database Prepare Study data in the eCTD – Electronic Common Technical Document format E-Submission Gateway 6th Annual Conference on Global Drug Development and Market Access October 15-18, 2011 | Mumbai, India
  23. 23. Benefits of using Electronic Systems in Early Phase Clinical Studies6th Annual Conference on Global Drug Development and Market AccessOctober 15-18, 2011 | Mumbai, India
  24. 24. Benefits of using Electronic Systems Sensitive audit trail  Increased GCP Regulatory Compliance, lesser audit queries Process automation through applications & medical devices integration  Achieve end to end operational excellence Electronic Data Entry & Alerts  Eliminate erroneous, time consuming - Manual data entry, Label preparation and QC procedures Real Time Data Availability  Facilitates Study performance (Drug & Volunteer) evaluation and overall study activities tracking 6th Annual Conference on Global Drug Development and Market Access October 15-18, 2011 | Mumbai, India
  25. 25. Benefits of using Electronic Systems Centralized Study Database  Integration of data from different instruments and devices, Enhances speedy query resolution and facilitates generation of in-built periodic and final study reports Electronic Data  Favors FDA recommended e- submission of clinical data for approval Overall it increases the value proposition, operational excellence and confidence on quality of research conducted by the organization. 6th Annual Conference on Global Drug Development and Market Access October 15-18, 2011 | Mumbai, India
  26. 26. Electronic Systems Implementation Considerations & Overall Plan6th Annual Conference on Global Drug Development and Market AccessOctober 15-18, 2011 | Mumbai, India
  27. 27. Considerations in the use of Electronic Systems 21 CFR Part 11 Compliant Accurate, complete, timely, verifiable and easy to use Secure with no loss of performance, stability & availability Integration capabilities with the centralized database Sensitive in recording & alerting minute errors Easily maintained and re-validated over a period of time Facilitate reduction of resources (Manpower, Time & Money) 6th Annual Conference on Global Drug Development and Market Access October 15-18, 2011 | Mumbai, India
  28. 28. Electronic Systems – Implementation Plan Items • Perform exhaustive vendor analysis 1 • Evaluate regulatory compliance & product performance 2 • Perform risk evaluation & mitigation activities 3 • Examine electronic system integration & continuous 4 support • Estimate costs, effort & resources involved 5 • Prepare, review and approve the “Change Management 6 Plan & Process” 6th Annual Conference on Global Drug Development and Market Access October 15-18, 2011 | Mumbai, India
  29. 29. Implementing Electronic Systems in Clinical Units Strategize Design Transition Operate Improve Re-engineer the Build and test Execute and Implement CAPADetermine Scope, current process, mock study support trial and evaluateResources, Level implement and workflows and activities with the process loop holesof electronic validate the associated newly tailoredautomation electronic system processes process Identifyrequirements opportunities for Evaluate & change Provide training Continuously increasingEvaluate process and validate the monitor the compliance, organizationalrisks and entire study processes and operational structure andcompliance design & conduct perform gap excellence and workflowconstraints lifecycle assessments business value governance Processes Electronic Systems & Information Technology Organization Governance & Reporting 6th Annual Conference on Global Drug Development and Market Access October 15-18, 2011 | Mumbai, India
  30. 30. Summary Early Phase Clinical Studies involve time-based complex clinical assessments with the additional constraints of volunteer recruitment targets, constant bedside monitoring & sample management The scope for GCP non-compliance is increased by the challenges of timely communication & parallel conduct of study activity procedures Electronic Systems such as barcode scanners, IVRS, EDC systems etc. have proven to significantly increase GCP compliance with the salient features of process automation, sensitive audit trail & Real time data availability The use of electronic systems require meticulous planning in the vendor selection and implementation process and should take place with the organization‟s overall „Change Management‟ approach. 6th Annual Conference on Global Drug Development and Market Access October 15-18, 2011 | Mumbai, India
  31. 31. Conclusion Thank You for your attention ! For further information, assistance & queries you are most welcome to contact us. Vinoth Kumar T Techsol Corporation, Hyderabad E: vinoth.kumar@techsolcorp.com M: +91 - 9666366782 W: www.techsolcorp.com Interpreting Life Sciences Solutions 6th Annual Conference on Global Drug Development and Market Access October 15-18, 2011 | Mumbai, India

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