This document discusses technology-enabled global harmonization of safety reporting using local laws. It summarizes Roche's experience developing the Clinical Trial Safety Portal (CTSP) to address the challenges of differing safety reporting rules across countries. Key points include: (1) CTSP allows sites to set preferences according to local laws while providing a standardized global process, (2) It reduces costs and burden on sites by consolidating safety documents and automating distribution, (3) Roche estimates the system saved over $80 million in the first year through increased compliance and reduced workload.

1. Technology-enabled Global
Harmonization of Safety
Reporting using Local Laws
Think Globally. Report Locally.

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Speaker
Steven Beales
Senior Vice President, IT
Market Owner, Safety Solutions
Today’s Speaker

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The views and opinions expressed in
this presentation and any related
discussion(s) are solely those of the
individual presenter(s) and do not
express the views of and opinions of
Roche or WCG.

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Lack of Global Harmonization
in Reporting Rules is Drug
Safety’s No. 1 Challenge *
What are we going to learn today?
+ 97% solved based on individual Site and IEC rule exceptions
Roche has solved it +
* Clinical Trials 2017, Vol 14

5. 14% SUSARs met criteria
FDA Study Audit
Increases cost
5
Increases site burden
Why is it important to learn this now?
$2m for Safety Reporting
1 Roche Study
80% Sites receive > 20
Safety Reports per Month
Increases compliance risk

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Have worked with Roche for 9
years building solutions to
this Global problem
In March 2017, we launched
Clinical Trial Safety Portal 2.0
(CTSP)
Why Listen to Me?

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* Roche Internal Estimate
$80 million*
* Verified on-time delivery to
trained user
99%*
* WCG Calculation
10 hours
per week*
Year 1 Cost
Savings
Sites in
Compliance
Reduction in
Site Burden
Our results after 1 year of CTSP 2.0

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The Problem

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* CTTI IND Safety Advancement Project Investigator Survey 2015
20% of Sites refused to
process SUSARs
Fear of Regulatory
Repercussion
Indeterminate Causality
Lack of Global
Harmonization
IND Safety Reporting is a “failed system” *
47% reduction in US SUSARs
3 out of 5 countries have
unique rules

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The Solution

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Business users
must be able to
set up the rules.
Configuration of business rules must be ‘simple’
process that doesn’t need IT or coding skills.
Roche created their own process and system
Realizing Local Country Laws will never harmonize
Making the Complex feel Simple

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Bacon Bits
e.g. Creamy Salad
Dressing
Picking Wrong Options
Opting-out
Leads to Bad Behavior
Allowing sites, CROs and
ECs to set Preferences
The Wrong Way – Take Whatever You Want

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3% Exception Rate
Central Safety Profile with
Local Options for Countries to
Choose
Find the patterns in each
country’s regulations
The Right Way – Picking off The Set Menu

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• All internationally recognized safety documents for IMP
compounds for Investigators and IRB/IECs on Interventional
Studies
Availability
• Alerting Options are set globally
Standardization &
Transparency
• Each country defines country alerting rules from the global
alerting options
• All safety documents available in system
Customization &
Flexibility
• Alerted that new safety documents are available based on the
country alerting rules.
• Can receive “all alerts” if required.
Investigator & Ethics
Committee
Clinical Trial Safety Portal

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Quality Oversight
Accountabilities Fragmented Process Compliance
Resources
Sites/IRB/IECs Study Teams Monitors
Over-Distribution
Fragmented Process Multiple Interpretations of local law Study Level Distribution
Lack of Global Harmonization
Unclear rules Accountabilities Consistency and Application
Roche before CTSP

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• Single end to end process
• All studies, countries and partners
Global Process
• 1 Safety document per recipient – for all studies
Compound Level Distribution
• Global Standards
• Safety Document Characteristics
• Country Rules
Aligned Global vs Local Law
• Relevant safety details up front
• Training
• All information is available
Direct Distributions to the Principal Investigator
Roche after CTSP

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“Just ask the affiliates.
They know what they need”
Raw Intelligence is not
operationalizable
Needed rigorous guidelines to collect Country Rules to
avoid “we’ve always done it this way” syndrome
Mistakes We Made
Retrain CROs, Sites, ECs and Internal Staff on new
processes or you won’t realize the benefits

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If we can, so can you
Follow Roche’s Process
It feels Overwhelming but is Solvable
Own it – Drug Safety/Clinical Operations
Acknowledge you have a problem
What can you do to take action now?

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Speaker
Steven Beales
sbeales@epharmaolutions.com
610-834-6209
https://www.linkedin.com/in/stevenbeales/
@stevenbeales
Q & A Session