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DIGITAL RISK MANAGEMENT - Huron Consulting Group

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DIGITAL RISK MANAGEMENT A new opportunity for customer engagement By Simon Ingate DIGITAL EFFECTIVENESS USER ENGAGEMENT INTERACTIVE ENGAGEMENT INTUITIVE NAVIGATION KNOWLEDGE TESTING MOBILE FRIENDLY ACCESS 24/7 SEARCHABLE PDF GUIDES SUPPORT GROUPS CONSTANTLY UPDATED MULTI-LANGUAGE KNOWLEDGE TESTS REAL-TIME DATA ALERTS ADVERSE EVENT MONITORING UTILISATION METRICS USER FEEDBACK PLAIN LANGUAGE CONTACT DETAILS CONTENT Digital aRMMs provide several benefits: Delivered digitally - reducing the need for paper materials Interactive user-friendly content to enhance usability. Accessible - available 24/7 in multiple languages across different digital devices Interactive knowledge assessment - opportunities for users to test their understanding though quizzes Effective data gathering – instant information on number and location of users and information being accessed Continuous improvement - data, answers to quizzes and feedback surveys enable improved future versions that deliver ongoing evidence-led improvements Several Top 10 pharmaceutical companies leverage digital aRMMs to provide interactive education that is more readily available and may be more effective than paper tools. Digital approaches not only offer greater customer engagement, they can also deliver realtime effectiveness evaluation metrics. Background Under current GVP 1 guidance, pharma companies are required to assess the effectiveness of aRMMs 2 . Tracking the distribution and use of paper materials can only be achieved with a Post Authorisation Safety Study (PASS). These are expensive, time consuming and difficult to manage, as they involve surveys and contacting and recruiting healthcare professionals (HCPs) and patients. The Solution Digital aRMMs A number of leading Pharma companies are now delivering aRMMs digitally. Although some explanation and discussion with regulators has been required, digital aRMMs have generally been well received by health authorities, HCPs and medical field forces. Digital aRMMs provide real-time feedback, meaning their effectiveness can constantly be assessed and are expected to provide effectiveness information without the need for additional PASS studies.
Transcript

DIGITAL RISK MANAGEMENT A new opportunity for customer engagement

By Simon Ingate

DIGITAL

EFFECTIVENESS

USER ENGAGEMENT

INTERACTIVEENGAGEMENT

INTUITIVE NAVIGATION

KNOWLEDGETESTING

MOBILE FRIENDLY

ACCESS 24/7

SEARCHABLE

PDF GUIDES

SUPPORT GROUPS

CONSTANTLY UPDATED

MULTI-LANGUAGE

KNOWLEDGE TESTS

REAL-TIME DATA

ALERTS

ADVERSE EVENTMONITORING

UTILISATION METRICS

USER FEEDBACK

PLAIN LANGUAGE

CONTACT DETAILS

CONTENT

Digital aRMMs provide several benefits:

• Delivered digitally - reducing the need for paper materials

• Interactive user-friendly content to enhance usability.

• Accessible - available 24/7 in multiple languages across different digital devices

• Interactive knowledge assessment - opportunities for users to test their understanding though quizzes

• Effective data gathering – instant information on number and location of users and information being accessed

• Continuous improvement - data, answers to quizzes and feedback surveys enable improved future versions that deliver ongoing evidence-led improvements

Several Top 10 pharmaceutical companies leverage digital aRMMs to provide interactive education that is more readily available and may be more effective than paper tools. Digital approaches not only offer greater customer engagement, they can also deliver realtime effectiveness evaluation metrics.

BackgroundUnder current GVP1 guidance, pharma companies are required to assess the effectiveness of aRMMs2. Tracking the distribution and use of paper materials can only be achieved with a Post Authorisation Safety Study (PASS). These are expensive, time consuming and difficult to manage, as they involve surveys and contacting and recruiting healthcare professionals (HCPs) and patients.

The SolutionDigital aRMMs

A number of leading Pharma companies are now delivering aRMMs digitally. Although some explanation and discussion with regulators has been required, digital aRMMs have generally been well received by health authorities, HCPs and medical field forces.

Digital aRMMs provide real-time feedback, meaning their effectiveness can constantly be assessed and are expected to provide effectiveness information without the need for additional PASS studies.

HURON | 2DIGITAL RISK MANAGEMENT A NEW OPPORTUNITY FOR CUSTOMER ENGAGEMENT

Our ExpertiseHuron has over 15 years of expertise in risk management, and can guide clients through the entire process of digitising aRMMs, from concept and vision creation, tool design and testing, website and digital content builds, multiple stakeholder (including local markets) engagement, to generating translated, localised and compliant content. We are also experts in global project management, and can support you throughout the roll-out process.

We support:

• Developing interactive user centric education through digital aRMMs.

• Establishing change management approaches with global cross-functional colleague networks essential to successful implementation.

• Delivering technical solutions (in-house or with client IT) that meet regulatory commitments for educational and other materials

• Supporting local markets with expert advice in their interactions with regulators / health authorities to explain the new digital approach

• Managing the project globally from start to finish

Case studyHuron was approached by a client who had found through a PASS that the distribution and some aspects of understanding of the educational material they produced required improvement. We helped the client obtain agreement from the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) to implement digital aRMMs.

OutcomeHuron initially conducted a pilot, implementing interactive digital RMMs in eight countries using our proprietary SafetyGauge technology. We are now helping the client to deploy digital aRMMs worldwide in >35 countries and for three of their medicines.

huronconsultinggroup.com © 2019 Huron Consulting Group Inc. and affiliates. All RIghts Reserved. Huron in a management consulting firm and not a CPA firm, and does not provide attest services, audits, or other engagements in accordance with standards established by the AICPA or auditing standards promulgated by the Public Company Accounting Oversight Board (“PCAOB”). Huron is not a law firm; it does not offer, and is not authorized to provide, legal advice or counseling in any jurisdiction.

For more information please contact: Simon Ingate [email protected]

1. GVP - Good pharmacovigilance practices

2. aRMM – Additional Risk Management Measures


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