Operational Issues & Risks ERCOT Operations Planning August 22, 2008
Business and Operational Risks in Pharmaceutical Information
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Business and Operational risks in handling pharmaceutical information
17TH November 2011
Adrian Hampshire, BioPharm
Parambir Singh, BioPharm
Rob van Manen, Oracle
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Risk – a definition
● a situation involving exposure to danger
● the possibility that something unpleasant or unwelcome will happen
(Oxford English Dictionary)
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Outline
● What are business and operational risks?
o Broad scope
• e.g. What risks do you run if you don’t have a particular system or process in place?
o Narrow scope
• e.g. What risks do you run when implementing a complex system or process?
● What are some of the impacts if a risk occurs?
● How can we reduce the risks?
● What do we do about residual risks?
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Key steps and processes involved in a clinical trial • Trial design and planning • Obtaining regulatory approval • Planning and manufacturing/acquiring study drug • Recruiting investigators (enrolment, screening, inclusion) • Site start-up • Recruiting patients • Administering drug • Registering results • Raising and responding to data queries • Monitoring safety • Monitoring site execution • Verifying source document • Assembling results • Reconciliation • Analysing results • Reporting the trial • Closing the study
Each of these steps involves an individual process that is more or less complex.
Each process is supported/enabled by one or more IT or manual systems.
Each step therefore carries a number of key risks.
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Key risks
1. The step is not executed at all Simple example: If there is no process and system
for monitoring safety, patients are put at risk.
2. The step is executed incorrectly or incompletely
Simple example: If the design of the trial is inadequate or inappropriate, the results of the study may not answer the question that the study was designed to answer.
Conclusion: We need a robust and complete set of
process and systems to support those processes throughout the lifecycle of the study.
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Change = Risk
Implementing a new process and system(s) = change
Change = Risk
Risks are: ● Strategic risks
● Programme risks
● Operational risks
● Project risks
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Management of risk
Four key actions: ● Identify the risk
● Assess the impact
● Reduce the impact
● Plan to handle the risks that can’t be eliminated
Optional fifth key action: ● Outsource the risk
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Outsourcing risk
Sponsor outsources the trial to a CRO ● The sponsor is paying the CRO to take on the risk, for a price.
Sponsor or CRO deploys a system to help manage any of the clinical trial processes ● They “outsource” a proportion of the risk to the developer/
vendor of the system, again, for a price.
In both cases, the organisation shares the risk with a supplier who, because they have executed the process many times or have built the software through many iterations over many years, consequently run a much reduced level of risk.
CAVEAT: If key processes of the trial are outsourced, we need to be clear who “owns” the risk and takes responsibility for addressing it.
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Commercial packages reduce risk
A pre-packaged solution: ● Built on best practices ● Delivers probably 80% of what the customer needs ● Gives the organisation the choice to o configure the system to meet the missing 20% o change their process such that the 80% provided by the pre-
packaged solution meets 100% of requirements
● Greatly reduces the risk because all prior implementations and the design choices and changes made as a result of these projects have already incurred those risks
● Reduces validation and testing requirements because much of this is address when the pre-packaged solution is constructed
● Has the potential to speed up the implementation by an order of magnitude. o Example: ASCEND reduces implementation time from 8-10
months to 8-10 weeks
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Two examples in detail
ASCEND ● Reducing risk by implementing a pre-configured
version of a complex CTMS solution (Siebel Clinical)
Parambir Singh, Vice President, Clinical Trial Management Solutions at BioPharm Systems
Argus Safety and Empirica Signal ● Reducing risk by implementing a commercially
available, proven and market-leading safety and risk management solution suite
● Rob van Manen, Master Principal Sales Consultant at Oracle HSGBU
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Introduction
A CTMS helps mitigate the risks of: ● Skipping a step
● Executing a step incorrectly
Siebel Clinical’s design is particularly helpful at mitigating risk ● Template-driven
A pre-packaged version of Siebel Clinical, such as ASCEND, further mitigates risk
● Industry standards and best practices
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Agenda
Topic
Introduction & Agenda
Recruiting Investigators
Site Start-Up
Recruiting Patients
Monitoring Site Execution
Closing the Study & Conclusion
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Recruiting Investigators
Assessment Templates: Standardized evaluation criteria and answer choices ● Ensure investigators are evaluated consistently and objectively
● Complete one assessment multiple times or several different assessments for each investigator
● Associate a percentage score with each investigator
Siebel Clinical
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Recruiting Investigators
Target Lists: Complex investigator searches ● Allow users to search for investigators:
o in the right location
o with the right patient population
o with the right experience
o with the right assessment scores
ASCEND
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Site Start-Up
Activity Templates: Standardized sets of tasks and documents ● Reflect content of SOPs
● Ensure same tasks are completed and same documents are collected across all sites
● Can have separate templates for each country to reflect different requirements
Siebel Clinical
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Site Start-Up
Activities & Document Tracking: Focused tracking areas ● Utilizing the SC separate views due to different tracking needs for
activities vs. documents
● Tailored fields and field dropdown choices in each view
● Document Tracking Screen which includes all documents also includes indication of what level the document is related to
ASCEND
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Recruiting Patients
Subject Visit Templates: Standardized subject visit schedules and payment amounts ● Created per protocol and applied to each site and patient
o Can be versioned to reflect protocol amendments
● Payment amounts can be modified at the site level (modifications are documented)
● Payment process ensures no visits are paid for more than once
Siebel Clinical
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Recruiting Patients
Subject Information: Improved tracking ● Able to record IRB Approval dates for protocol amendments that
do not affect the visit schedule and therefore do not require new Informed Consent
● Able to track individual subject treatment arms and change treatment arms mid-study
● Able to track details about subject-specific protocol deviations and adverse events
ASCEND
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Monitoring Site Execution
Trip Report Templates: Standardized tasks and questions ● Reflect content of SOPs
● One template for each type of visit
● Created centrally and then applied to each site visit record
● Ensure same information is recorded, tasks are completed, and questions are answered for each visit type across all sites
Siebel Clinical
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Monitoring Site Execution
Trip Report Completion: Expanded to include more information ● Separated yes/no questions from narrative response questions
● Allow relevant PD, SAE, Follow-Up Item, and CRF Tracking records to be imported as a snapshot in time
● Records complete approval history audit trail to comply with 21 CFR Part 11
ASCEND
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Closing the Study
Activity Templates: Standardized sets of tasks and documents ● Reflect content of SOPs
● Ensure same tasks are completed and same documents are collected across all sites
● Can have separate templates for each country to reflect different requirements
● Rollup views allow quick access to subject, site, and country/region statuses to confirm all child records are in a terminal status
Siebel Clinical
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Closing the Study
Activities & Document Tracking: Focused tracking areas ● Utilizing the SC separate views due to different tracking needs for
activities vs. documents
● Tailored fields and field dropdown choices in each view
● Document Tracking Screen which includes all documents also includes indication of what level the document is related to
ASCEND
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Conclusion
• Implementing a CTMS helps to mitigate risk by providing a central location for clinical trial management information
• Siebel Clinical is particularly helpful at mitigating risk due to its template-driven design
• A pre-packaged version of Siebel Clinical, such as ASCEND, further mitigates risk by adhering to industry best practices and including commonly-requested enhancements right out of the box
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Introduction
A case processing system can help mitigate process-related compliance risks, such as:
● Failing to comply with adverse reaction regulations
- Failing to report certain cases
- Failing to comply with regulatory reporting deadlines
A signal detection environment can contribute in mitigating product-related risks, such as:
● Failing to timely detect product-related adverse reactions
- Failing to perform correct clinical assessment of potential signals
- Failing to take appropriate action and document this
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Case Processing
Activities:
● Data collection and entry
● Coding
● Medical review
● Reporting
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Case Processing: Data Entry
Risks and safeguards: ● Incomplete data: Data completeness checking
- Avoid missing key information such as patient, product, event or reporter
● Incorrect data: Data correctness checking
- Dates and numbers
- Upper and lower boundaries
● Inconsistent data: Data consistency checking
- Starting and ending dates; continuing exposure/event
- Seriousness criteria
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Case Processing: Coding
Risks and safeguards: ● Incorrect coding
- Use of auto-encoders, supporting powerful multi-step coding
algorithms
- Use of coding review procedures
● Inconsistent coding
- Use of standard synonym lists
- Code propagation capabilities
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Case Processing: Medical review
Risks and safeguards: ● Incorrect assessment of reportability
- Providing all relevant information in an easily accessible way
● Undocumented assessments
- Importance of easy to use functionality to capture medical
assessment results (including audit trail)
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Case Processing: Regulatory reporting
Risks and safeguards: ● Reports not submitted
- Automatic report requests based on regulatory requirements
● Reports submitted too late
- Report tracking with reminder capabilities
● Incorrect report type, e.g. periodic versus expedited reporting
- Reportability assessment combined with automatic report requests
● Reports not adequately documented for auditing purposes
- Built-in report tracking and auditing
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Signal Detection
Background:
● Regulators have published signal detection guidance documents and are in the process of implementing signal detection requirements
● Regulators are performing quantitative signal detection themselves and have been confronting companies with potential signals
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Regulatory Guidance on Signal Detection
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Examples of Regulatory and Public-Private Initiatives
Europe: ● ENCePP (European Network of Centres for Pharmacoepidemiology and
Pharmacovigilance)
● IMI-PROTECT (Innovative Medicines Initiative - Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium)
● EU-ADR
US: ● Sentinel and Mini-Sentinel
● Observational Medical Outcomes Partnership (OMOP)
Japan: ● Mihari
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Signal Detection Activities by Regulators
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Signal Detection Activities by Regulators
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Signal Detection Activities by Regulators ● FDA
o Empirica Signal in production at CDER, CBER, CDRH and CFSAN - quarterly overview of potential signals currently under evaluation
o Empirica Study and WebSDM in production at CDER and CBER
● EMA – EudraVigilance
o In-house developed quantitative signal detection tools (PRR)
● MHRA
o Empirica Signal – Signal Management in production – Drug Analysis Prints
● MHLW – PMDA
o Developing quantitative signal detection tools as part of the Mihari initiative
● Other countries:
o Netherlands (Lareb): In-house quantitative signal detection tools (ROR)
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Signal Detection: Risks and Safeguards
Risks: ● Non-compliance with current regulatory guidelines and upcoming
regulations with respect to quantitative safety signal detection
● Previously unknown signals identified by regulators through quantitative safety signal detection
Safeguards: ● Implementation of processes and systems for standardized, systematic,
documented quantitative signal detection and signal management
● Application of methods and systems for data cleaning and signal detection as similar as possible to those used by the authorities
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Questions?