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Safety System Upgrades POV
Past and Future Trends Driving the Decision to Upgrade
09/14/2017
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Present state of safety system upgrades .............................................4 Upgrade benefit drivers and cost determinants ..................................5 Upgrade cost determinants .................................................................6 Significance of upgrade benefit drivers and cost determinants ..........7 The future of safety system upgrades .................................................8 Predictions for the future .....................................................................9 Authors ...............................................................................................10
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Present state of safety system upgrades For the past several decades, the focus of safety systems has generally been on the collection, processing, and reporting of safety information. The process-heavy nature of these systems often drove organizations to select their systems based on the ability to organize data and optimize efficiency, typically leaving limited system options. With increasing demands of traditional safety
systems, many organizations are facing significant cost burdens to maintain and upgrade their systems. Deloitte performed a qualitative, retrospective review of safety system upgrades over the past decade to evaluate how the cost-benefit balance may be changing as a result. As seen in Figure 1, a retrospective review reveals a correlation between upgrade cost and the duration
between upgrades, regardless of company size. The majority of organizations upgrade every 2-5 years; however, delayed upgrades may avoid short-term costs but not necessarily save costs over the long-term.
Figure 1
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Upgrade benefit drivers and cost determinants The retrospective review revealed common benefits organizations evaluate in their decision to upgrade, and the main determinants of their cost to upgrade.
Upgrade benefit drivers Historical review shows four common benefit drivers that motivate system upgrades:
Regulatory Compliance: Requiring companies maintain compliance with changing regulations, globally. Business Requirements: Requiring companies to harmonize processes globally and across business units.
Technical Requirements: Requiring companies to achieve or retain compatibility with internal systems, technical services, multiple “tenants” in a single system, and vendor support for aging systems.
Business Situation: Requiring companies to support changing business models such as outsourcing, globalization, harmonization, and new partners or service providers.
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Upgrade cost determinants Historical review shows four common determinants of the cost to upgrade:
Current State of Safety Systems: Volume and complexity of existing databases and system configurations. User Base: Volume and complexity of user access points, security, unique requirements, and privacy restrictions.
Implementation Resources: Maturity of the quality system, including the validation framework, policies, and procedures, along with the extent of validation required.
System Complexity: Whether it is a minor upgrade to an existing system, a major overhaul of an existing system, or a migration to a completely new system.
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Significance of upgrade benefit drivers and cost determinantsThe significance of each upgrade benefit and cost determinant is illustrated in the following graphic, highlighting the variation that each benefit driver and cost determinant has on the overall decision to upgrade.
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The future of safety system upgradesThe pharmacovigilance (PV) function as a whole has often been impacted by global industry trends, including recent trends such as an increase in healthcare access and treatment worldwide, consolidation and re-structuring within the biopharmaceutical industry, public health and patient-centered care, technological advances, and expansion of real world evidence (RWE). These trends can bring key benefits and insights, while putting added pressure on PV functions:
• A growth in PV market size is demanding stronger PV systems
• An increasing need for pharmaceutical visibility creates new sources and inputs of PV data
• Expanding, yet unstructured, data sets require PV functions to draw insights from increasingly complex data sets
• Commoditization of PV activities is increasing flexibility and agility
• Availability of RWE is allowing PV functions to make more timely and accurately safety decisions
It is projected that these industry trends may change how organizations evaluate the significance of the benefit drivers and the cost to upgrade, putting a greater emphasis on costs, as seen below.
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Under the current safety system paradigm, industry trends may cause the costs of traditional approaches to safety system upgrades to grow disproportionally to benefits, and these approaches may shift as the incremental value of upgrading decreases.
Predictions for the futureIn the short-term, traditional approaches to safety system upgrades will likely be pursued, however, as the value continues to decrease and PV activities are commoditized, the industry may see a shift away from safety systems owned by the biopharmaceutical companies, to a shared repository for drug safety information.
The shift toward non-traditional safety information management platforms can pave the way for agile newcomers focused on analytics and patient-centered data collection, and will likely decrease the overall volume of safety system upgrades. In addition, increased data capture
Safety System Upgrades POV
Authors Glenn Carroll Principal Life Sciences and Health Care Deloitte Consulting LLP +1 212 313 2623 [email protected]
Amanda Kirby Bowles Specialist Leader Life Sciences and Health Care Deloitte Consulting LLP +1 213 553 1286 [email protected]
Sarah Kaulfuss Manager Life Sciences and Health Care Deloitte Consulting LLP +1 617 437 3608 [email protected]
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This publication contains general information only and Deloitte is not, by means of this publication, rendering accounting, business, financial, investment, legal, tax, or other professional advice or services. This publication is not a substitute for such professional advice or services, nor should it be used as a basis for any decision or action that may affect your business. Before making any decision or taking any action that may affect your business, you should consult a qualified professional advisor. Deloitte shall not be responsible for any loss sustained by any person who relies on this publication.
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