Operationalizing ICH E6 (R2) · Medical Monitors to significantly improve the speed, safety and...
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Operationalizing ICH E6 (R2) Best Practices and Tips What does the FDA Expect from ICH E6 (R2)? Improved and more efficient approaches to clinical trials DESIGN - Efficient protocols, data collection tools and procedures for decision making. CONDUCT - Methods used to assure and control the quality of the trial should be proportionate to the risks. OVERSIGHT - Sponsor should ensure oversight of any trial-related duties and functions carried out on its behalf. RECORDING - Ensure data integrity including any data that describes the context, content and structure. REPORTING - A systematic, prioritized, risk-based approach to monitoring. Results to be provided to the sponsor in a timely manner. AUTOMATION - All information should be recorded, handled, and stored for accurate reporting, interpretation and verification. In a recent CRO Oversight Benchmark Survey of more than 100 clinical operations leaders, 100% of respondents said they needed to make process changes due to the upcoming ICH E6 (R2) addendum. However, when asked what they were using for CRO oversight and collaboration, 90% said they were still using spreadsheets. Greatest Challenges to Supporting the Changes in ICH E6 (R2) Competing Priorities Hinder Focus “What do you see as the biggest challenge to addressing change in ICH E6 (R2)?” #1 - Maintaining proper reporting from a risk-based approach #2 - Improving communication & collaboration #3 - Creating joint metrics 84% of sponsors still use e-mails as primary system for escalating CRO issues Nearly 80% of respondents claimed real-time insights into risk was a top priority How to Align FDA’s Guidance with Process and Automation Sponsors ask “How to go from here?” “To here?” “What is your Top Technology Priority for ICH E6 (R2)?” #1 Data Analytics & Aggregation across Systems and Studies Gaining Value from Process and Automation The 12 Steps of Operationalizing ICH E6 (R2): A Workflow About Comprehend Comprehend offers a suite of Clinical Intelligence applications that enables ClinOps Execs, Data Managers and Medical Monitors to significantly improve the speed, safety and quality of a portfolio of clinical trials. Across studies, sites, systems and CROs, Comprehend's Clinical Intelligence Suite is particularly effective for centralized monitoring, risk monitoring, CRO oversight and collaboration, data review and medical monitoring initiatives. With powerful capabilities to intelligently unify, monitor, and analyze clinical data across CROs, studies and systems, Comprehend gives life sciences companies the ability to address the most difficult and complex FDA guidelines for quality, risk and oversight. Comprehend: the speed to quality results. www.Comprehend.com Comprehend Systems, Inc. 2010 Broadway, Suite 200 Redwood City, CA 94063 1-650-521-5449 [email protected] This publication is not to be reproduced in whole or in part without the written permission of Comprehend Systems, Inc. ©2017 Comprehend Systems. All rights reserved. View the full webinar here 12 Best Practice Steps of Operationalizing for ICH E6 (R2) ICH E6 (R2) Ready 1. Identify metrics 2. Convert metrics into KPIs 3. Determine thresholds 4. Define communications 5. Define sponsor-CRO roles 6. Establish risk Impact 7. Define escalation 8. Define data transfer 9. Aggregate and normalize data from all sources 10. Employ analytics and KPIs 11. Use dashboards for real-time status 12. Gain real-time insights and turn them into action “What prevents you from addressing ICH E6 (R2) and achieving milestones on time?” 83% of sponsors consider risk reduction and ICH compliance a top priority The ICH E6 (R2) Guidance
Transcript of Operationalizing ICH E6 (R2) · Medical Monitors to significantly improve the speed, safety and...
Operationalizing ICH E6 (R2) Best Practices and Tips
What does the FDA Expect from ICH E6 (R2)?Improved and more efficient approaches to clinical trials
DESIGN - Efficient protocols, data collection tools and procedures for decision making.
CONDUCT - Methods used to assure and control the quality of the trial should be proportionate to the risks.
OVERSIGHT - Sponsor should ensure oversight of any trial-related duties and functions carried out on its behalf.
RECORDING - Ensure data integrity including any data that describes the context, content and structure.
REPORTING - A systematic, prioritized, risk-based approach to monitoring. Results to be provided to the sponsor in a timely manner.
AUTOMATION - All information should be recorded, handled, and stored for accurate reporting, interpretation and verification.
In a recent CRO Oversight Benchmark Survey of more than 100 clinical operations leaders, 100% of respondents said they needed to make process changes due to the upcoming ICH E6 (R2) addendum.
However, when asked what they were using for CRO oversight and collaboration, 90% said they were still using spreadsheets.
Greatest Challenges to Supporting the Changes in ICH E6 (R2)Competing Priorities Hinder Focus
“What do you see as the biggest challenge to addressing change
in ICH E6 (R2)?”
#1 - Maintaining proper reporting from a risk-based approach
#2 - Improving communication & collaboration
#3 - Creating joint metrics
84% of sponsors still use e-mails as primary system for escalating CRO issues
Nearly 80% of respondents claimed real-time insights into risk was
a top priority
How to Align FDA’s Guidance with Process and Automation
Sponsors ask “How to go from here?” “To here?”
“What is your Top Technology Priority
for ICH E6 (R2)?”
#1 Data Analytics &
Aggregation across Systems and Studies
Gaining Value from Process and Automation
The 12 Steps of Operationalizing ICH E6 (R2): A Workflow
About ComprehendComprehend offers a suite of Clinical Intelligence applications that enables ClinOps Execs, Data Managers and Medical Monitors to significantly improve the speed, safety and quality of a portfolio of clinical trials. Across studies, sites, systems and CROs, Comprehend's Clinical Intelligence Suite is particularly effective for centralized monitoring, risk monitoring, CRO oversight and collaboration, data review and medical monitoring initiatives. With powerful capabilities to intelligently unify, monitor, and analyze clinical data across CROs, studies and systems, Comprehend gives life sciences companies the ability to address the most difficult and complex FDA guidelines for quality, risk and oversight. Comprehend: the speed to quality results. www.Comprehend.com
Comprehend Systems, Inc.2010 Broadway, Suite 200Redwood City, CA [email protected]
This publication is not to be reproduced in whole or in part without the written permission of Comprehend Systems, Inc.©2017 Comprehend Systems. All rights reserved.
View the full webinar here
12 Best Practice Steps of Operationalizing for ICH E6 (R2)
ICH E6 (R2)
Ready
1. Identify metrics
2. Convert metrics into KPIs
3. Determine thresholds
4. Define communications
5. Define sponsor-CRO roles
6. Establish risk Impact
7. Define escalation
8. Define data transfer
9. Aggregate and normalize data from all sources
10. Employ analytics and KPIs
11. Use dashboards for real-time status
12. Gain real-time insights and turn them into action
“What prevents you from addressing ICH E6 (R2) and achieving milestones on time?”
83% of sponsors consider risk reduction and ICH compliance a top priority
The ICH E6 (R2) Guidance
