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

The Use of Electronic Systems
in Early Phase Clinical Trials for
Ensuring GCP Compliance

Mr. Vinoth Kumar T
Assistant Manager – Delivery Lead
(E-Clinical Technologies)

Interpreting Life Sciences Solutions

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
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any organization with which the presenter is employed or affiliated.

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respective owners.

6th Annual Conference on Global Drug Development and Market Access
October 15-18, 2011 | Mumbai, India

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


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)


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


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


Issues & Reasons for
GCP non-compliance
in Early Phase Studies


Issues of GCP compliance in Early Phase Studies
GCP INSPECTIONS METRICS REPORT - Phase I Clinical Units


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


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


Potential Electronic Systems for
Early Phase Clinical Units


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


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)


Potential Electronic Systems for Early Phase Clinical Units

Early Phase
Clinical Trial
Electronic Devices


Electronic Systems in Early Phase Clinical Trials

Volunteer Volunteer Clinical
Verification Recruitment Study Setup


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


Electronic Systems in Early Phase Clinical Trials

Study Query Study
Conduct Management Closure


1. Electronically Automated Process - Volunteer Recruitment

Volunteer Screening Form Volunteer Enrollment Volunteer Biometrics

Centralized Study Database

Telephone Screening

Volunteer Barcode ID & Volunteer Online Data Entry Volunteer Screening
Wristband Label Generation Database


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


Sample vessel
allocated / volunteer

Setup Freezer, Study E – CRF
Sample storage Perform Environmental Design & Edit Checks
& Ward Temperature Alerts Monitoring Programming


3. Electronically Automated Process - Study Conduct
Record trial data using Bedside Medical Devices Record Volunteer Clinical
Sample Collection Time

Scan Sample Barcode Labels / Volunteer


CRA Monitoring

Instant Online Queries
Sensitive 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


4. Electronically Automated Process - Study Closure

Database Quality Study Queries Drug Accountability
Lock Control resolved


Drug Safety Database

Final Study
Reports Volunteer Trial
participation Tracked

Written on to CDs
for regulatory
submission Study Documents Tracking & Archival Volunteer Exit


4. Electronically Automated Process - Study Report Submission

Centralized Study Database Prepare Study data in the
eCTD – Electronic Common
Technical Document format

E-Submission
Gateway


Benefits of using Electronic Systems
in Early Phase Clinical Studies



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



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.


Electronic Systems Implementation
Considerations & Overall Plan


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)


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”


Implementing Electronic Systems in Clinical Units

Strategize Design Transition Operate Improve

Re-engineer the Build and test Execute and Implement CAPA
Determine Scope,
current process, mock study support trial and evaluate
Resources, Level
implement and workflows and activities with the process loop holes
of electronic
validate the associated newly tailored
automation
electronic system processes process Identify
requirements
opportunities for
Evaluate & change Provide training Continuously increasing
Evaluate process and validate the monitor the compliance,
organizational
risks and entire study processes and operational
structure and
compliance design & conduct perform gap excellence and
workflow
constraints lifecycle assessments business value
governance

Processes

Electronic Systems & Information Technology

Organization Governance & Reporting


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.


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


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

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