Changes in global regulatory requirements have motivated medtech companies to explore technologies that support clinical teams, while accelerating innovation and delivery of products to patients. Clinical operations software has evolved to automate high-volume manual activities and simplify reporting, enabling quick and informed business decisions throughout the clinical trial process.
The Veeva MedTech Clinical Benchmark Report indicates that 43% of companies anticipate improved clinical trial efficiency as the primary benefit of adopting new technology. Companies often struggle to understand what business decisions need to be made prior to implementing new technology, which can lead to substantial delays in implementation and hinder long-term user adoption. Conducting a Phase 0 analysis allows clinical leaders to assess organizational readiness, establish a solid foundation for implementation, and improve adoption.
Veeva’s Business Consulting team has identified three core pillars for success to establish business readiness before implementation and expedite value realization post-implementation:
The first objective of a successful Phase 0 analysis is to identify existing business processes that will be impacted by new technology. Veeva Business Consulting predicts that around 35-40% of digital transformations lose their maximum value when there is not a clear understanding of the current state. There can also be significant impact on the implementation timeline when business and technical requirements are not defined properly. It is critical to get a clear understanding of all business processes and differences across business units to identify pain points, areas for optimization, and potential risk. Organizations must establish a core team to gain cross-functional and inter-regional insights throughout the phase 0 analysis.
Key roles of the team include:
The core team should begin by conducting a series of information gathering activities to establish priorities. Analyzing existing documentation and data on current business processes identifies silos or redundancies that exist between divisions and geographies. This data informs subsequent interviews, surveys, and workshops with stakeholders to further understand workflows, communication channels, and pain points. The core team can take the information obtained throughout this process to identify and prioritize gaps, differences in process, and document inefficiencies. This evaluation helps define where and when key decisions need to be made in order to ensure a successful implementation.
Industry metrics show that approximately 45% of IT projects exceed budget when companies lack internal alignment and robust success metrics. The core team must design a future state where business processes are harmonized and streamlined across divisions. Once there is a clear future vision, it is crucial to align on what processes can be automated and how different business units will use the system.
Insights from the current state analysis help identify bottlenecks and inconsistencies, providing a framework to prioritize improvement areas to be the most impactful. Striking the right balance between standardization for consistency and flexibility to accommodate specific business needs is imperative. Companies should prioritize standardizing core processes prior to tailoring systems to meet the specific needs of different divisions and regions. Developing a shared vision establishes a foundation for how the system will be used post-implementation and creates opportunity for future customization to scale as your business needs change. It should also drive the definition of success metrics to measure progress and ensure value is being achieved.
Having a clear understanding of the levels of support end users will need prevents timeline delays and change fatigue. This third pillar focuses on the creation of a business readiness plan to create a foundation for collaboration and long-term system usage. An effective business readiness strategy should outline change activities and deliverables including a roll-out strategy, communication plan, governance structure for continuous system growth, and long-term training plan.
The plan will provide the organization with clear direction throughout implementation including roles and responsibilities for stakeholders. The business readiness plan should also identify potential risks and mitigations and should define a feedback mechanism to gather and prioritize input as requirements change. This feedback loop promotes efficacy and agility while maintaining momentum with users throughout the transformation.
Regardless of size, medtech companies undertaking technology transformations must address inefficient manual processes, data duplication, and disjointed systems. Out of 135 responses to the Clinical Benchmark Report, 60% of leading medtech companies indicate challenges with disparate clinical systems, emphasizing the need for a comprehensive understanding of the impact new technology will have on existing systems, processes, and people. However, clinical teams are often small and lean, typically lacking resources or expertise in implementing and adopting new technology. This is why it is imperative to understand the scope of change to fill in any knowledge gaps for the core team.
Veeva’s Business Consulting team has subject matter expertise in business processes and systems to support your Phase 0 analysis. To schedule a consultation contact business.consulting.comms@veeva.com