the use of electronic systems in early phase clinical studies for ensuring gcp compliance - vinoth...

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

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

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• 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

Agenda


• 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

Characteristics of Early Phase Studies


STUDY

CLOSURE

STUDY

CONDUCT

Overall Process of Early Phase Clinical Trials

STUDY

STARTUP

VOLUNTEER

RECRUITMENT

Volunteer enrollment

Volunteer participation history tracking

Volunteer screening

Volunteer recruitment

Resolve and close all queries

Consolidation of all external and internal study reports

Drug Accountability and Safety Reconciliation

Preparation & Submission of Final Study Report

Complex clinical pharmacology assessments

Record trial data Entry

Generate and manage queries online and off-line

CRA Monitoring

Sample collection, aliquoting & Shipment

Environment and IP Management Immediate reporting of AE and SAE’s

Study specific Labels creation

Designing of Paper CRF/ e-CRF Study IP and sample Inventory Tracking & Management


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 ?

SPEED

• Achieved through Automation

• Increased by Real time Data Availability

EFFICIENCY

• Achieved by device & apps Integration

• Better Process Control

• Proactive organizational Communication

COMPLIANCE

• Achieved with the sensitive Audit Trail

• Errors minimized through alerts and warnings

To Improve & Increase …..

Increase Value Proposition of the Organization


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 Clinics


Potential Electronic Systems for Early Phase Clinical Units

Early Phase Clinical Trial

Electronic Devices


Electronic Systems in Early Phase Clinical Trials

Volunteer Verification

Volunteer Recruitment

Clinical Study Setup


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

Significance of Barcodes in Early Phase Studies


Electronic Systems in Early Phase Clinical Trials

Study Conduct

Query Management

Study Closure


1. Electronically Automated Process - Volunteer Recruitment

Centralized Study Database

Volunteer Biometrics

Telephone Screening

Volunteer Screening Form Volunteer Enrollment

Volunteer ScreeningOnline Data EntryVolunteer

Database

Barcode ID &

Label GenerationVolunteer

Wristband


2. Electronically Automated Process - Study Start Up


Print volunteer linked

Clinical Sample Labels

Study E – CRF

Design & Edit Checks

ProgrammingPerform Environmental

Monitoring

Setup Freezer,

Sample storage

& Ward Temperature Alerts

Stick & scan Sample Barcode Labels / Volunteer

Configure wireless Network in the clinic ward

Sample vessel

allocated / volunteer

Document

Management System


3. Electronically Automated Process - Study Conduct


Record Volunteer Clinical

Sample Collection Time

Instant Online Queries

during E-CRF

Data Entry on Tablet PC

Scan Sample Barcode Labels / Volunteer

Record trial data using Bedside Medical Devices

Time alerts and warnings

on Mobiles and PDA’s

Sensitive Lab Instruments

& Temperature AlertsBlinding, Randomization,

IP Dispensing & Tracking

CRA Monitoring


4. Electronically Automated Process - Study Closure


Drug Accountability

Volunteer Exit

Study Queries

resolved

Database

Lock

Study Documents Tracking & Archival

Written on to CDs

for regulatory

submission

Final Study

Reports Volunteer Trial

participation Tracked

Quality

Control

Drug Safety Database

http://in.wrs.yahoo.com/_ylt=A0PDodmnIntObm4A8xW9HAx.;_ylu=X3oDMTBqNGtrdGs5BHBvcwM5NgRzZWMDc3IEdnRpZAM-/SIG=1nvjvcfqi/EXP=1316721447/**http:/in.images.search.yahoo.com/images/view?back=http://in.images.search.yahoo.com/search/images?p=barcode++binder&js=1&b=85&ni=21&ei=utf-8&y=Search&xargs=0&pstart=1&fr=sfp&w=150&h=371&imgurl=images.eason.ie.s3-website-eu-west-1.amazonaws.com/books/medium/5025874110681.jpg&rurl=http://www.easonschoolshop.com/category/Stationery/StationeryFiling/StationeryRingBindersLeverArch&size=37KB&name=contrast+ring+bi...&p=barcode++binder&oid=afdaab7f629fd0679a67cfcdf159280c&fr2=&no=96&tt=1960&b=85&ni=21&sigr=132q2ocka&sigi=12hcdd9tf&sigb=13rj7grvs&.crumb=RJwkoS/2bHr

http://in.wrs.yahoo.com/_ylt=A0PDodvLI3tOoREAmjO9HAx.;_ylu=X3oDMTBqamdoM3Q5BHBvcwMxMgRzZWMDc3IEdnRpZAM-/SIG=1hhj8si2n/EXP=1316721739/**http:/in.images.search.yahoo.com/images/view?back=http://in.images.search.yahoo.com/search/images?p=employee+database&ei=utf-8&fr=sfp&w=576&h=462&imgurl=www.databaseoasis.com/template-images/employees.jpg&rurl=http://www.databaseoasis.com/employees.html&size=146KB&name=Database+Oasis+-...&p=employee+database&oid=8ef51aef2b35baa0ae8b31a39e9ecffd&fr2=&no=12&tt=80100&sigr=11b7fjihg&sigi=11jmftrff&sigb=12j7ic6fc&.crumb=RJwkoS/2bHr


4. Electronically Automated Process - Study Report Submission


E-Submission

Gateway

Prepare Study data in the

eCTD – Electronic Common

Technical Document format


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

1• Perform exhaustive vendor analysis

2• Evaluate regulatory compliance & product performance

3• Perform risk evaluation & mitigation activities

4

• Examine electronic system integration & continuous support

5• Estimate costs, effort & resources involved

6

• Prepare, review and approve the “Change Management Plan & Process”


Implementing Electronic Systems in Clinical Units

Strategize Design Transition Operate Improve

Determine Scope,

Resources, Level

of electronic

automation

requirements

Evaluate process

risks and

compliance

constraints

Re-engineer the

current process,

implement and

validate the

electronic system

Evaluate & change

organizational

structure and

workflow

governance

Build and test

mock study

workflows and

associated

processes

Provide training

and validate the

entire study

design & conduct

lifecycle

Execute and

support trial

activities with the

newly tailored

process

Continuously

monitor the

processes and

perform gap

assessments

Implement CAPA

and evaluate

process loop holes

Identify

opportunities for

increasing

compliance,

operational

excellence and

business value

Processes

Electronic Systems & Information Technology

Organization Governance & Reporting


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.

Summary


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: [email protected]

M: +91 - 9666366782

W: www.techsolcorp.com

Interpreting Life Sciences Solutions

mailto:[email protected]

http://www.techsolcorp.com/

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