ICH GCP E6 (R2) : What is Oversight and how can we ensure it

Transcription

1 ICH GCP E6 (R2) : What is Oversight and how can we ensure it YURI MARTINA Ph.D., MBA, PMP Vice President/ Head Clinical Operations

2 Clinical Trials Fail Key points 12-June-18 Page 2

3 ICH GCP E6 R2 Approach to clinical trials Risk based approach to Clinical Trials Efficiencies Focus on critical points Quality by Design prevent errors 12-June-18 Page 3

4 In summary what ICH GCP E6 R2 is telling us is 12-June-18 Page 4

5 ICH GCP E6 R2 Oversight changes 5.2. Contract Research Organization (CRO) Vendors role and importance in Quality Ensuring proper execution of plans 12-June-18 Page 5

6 Definition of Oversight The action of overseeing something Watchful care or management; supervision Difference with Insight: The capacity to gain an accurate and deep understanding of someone or something Which one would you prefer? 12-June-18 Page 6

7 Insight Versus Oversight Mentality Element Insight Mentality Oversight Mentality Relationship Management Relationship focus management Reverse bow tie, layers Joint policies Service provider management focus Bow tie structure Agreement as risk avoidance Transformation Management Exit/Changes Management Agreement components as flexible Regular contact Focus on performance End-to-end metrics Rewards innovation Addresses how to handle future unknown Based on fairness Agreement components as fixed Infrequent communication Focus on service provider metrics No clear process for joint innovation procedures Focus on terms and conditions Use of power to negotiate more favourable conditions 12-June-18 Page 7

8 Tiered Governance Structure Daily Attended by peers from both parties Operational Management Group Day-to-day operations in different locations Monthly Attended by managers from both parties Joint Operations Committee Service delivery and mgmt. Progresses of outsourcing relationship Quarterly Attended by senior executives from both parties Board of Advisors Transformation management Goals, strategy, objectives and leadership 12-June-18 Page 8

9 Enablers for Governance Structure Key Performance Indicators Metrics Communication/escalation plans KPI -> create the vision and common objectives for the governance Metrics -> measure progresses and drive actions accordingly Plans -> establish who and when needs to be informed on issues 12-June-18 Page 9

10 Monitoring and co-monitoring Co-monitoring or sites visit attendance supports training, site feasibility, relationship building QC reps activities (visits and centralized checks) on-site and remote co-monitoring, issues resolution/prevention Standard QA activities controls and verifies, prepares for inspections 12-June-18 Page 10

11 Risk Based Approach to Clinical Trials Management Risk Assessment is the first step critical data points, critical processes/steps Risk review is used as the driver for meetings and follow ups ultimately focusing on issues/risks and not on what is according to plan Cross-functional approach and learning organization involves different functions and feedback loops Coming soon: IT tool -> priority 2 from our perspective 12-June-18 Page 11

12 Risk Based Monitoring Central Data Review It is only part of the cake Capitalize on previous data and prevent issues we use older data to set up our thresholds and measure at early stage Prevent end points failure and monitor placebo effect critical to have feedback loops and connection with other oversight activities Currently: Risk Based Monitoring Full and true RBM to be established IT system: CluePoint 12-June-18 Page 12

13 Trial Master File How well have we worked? If it is not documented it never happened It is the major focus for Agencies inspections Provides the opportunity to re-construct your study at all times Provides the opportunity for improved oversight Provides the opportunity for efficiencies 12-June-18 Page 13

14 Systems perspective ESF / epro / esource Labs core / Local IVRS / IWRS CTMS emonitoring ESF / etmf Resourcing Tool Risk Assessment / Management Risk Based Approach PM Tools 12-June-18 Page 14

15 The landscape is very crowded 12-June-18 Page 15

16 Inspiring Quotes Quote by Tom Wilson (Chief Risk Officer Allianz Insurance): Risk Management is a culture, not a cult. It only works if everyone lives it, not if it is practiced by a few high priests. Quote by Yoda from Star Wars: Named must your fear be before banish it you can. Quote from Seneca: It s not because things are difficult that we dare not venture. It s because we dare not venture that they are difficult. 12-June-18 Page 16

17 Thank you very much! Questions? 12-June-18 Page 17

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