In my previous post, I discussed the shortcomings of the old way of defining your company's clinical architecture. In this post, I will discuss a better way of defining clinical architecture.
Capabilities are King
Instead of focusing on features of systems and the needs of departments, one will need to shift their focus to capabilities required to execute a clinical trial. Sometimes this may align with functional/team groups within an organization, but more and more often, these capabilities/activities span multiple teams (and even companies).
So how does one know which capabilities they need to have within their organization? Well, it just so happens that I like to follow this four step process that will send those interested on a path towards ensuring their capabilities are defined and satisfied.
Step 1: Identify Strategy
Identify the Organizational Strategies, Vision, Goals and Objectives. By creating the blueprint of what an organization is going to be and what it will accomplish, one will have the framework needed to define/clarify your capabilities.
Step 2: Analyze and Document Current State Capabilities and Systems
Review current clinical lifecycle and process documentation and compare against best-practice clinical capability maps. Then, conduct a Voice of the Customer process to elicit high-level capability requirements. This information is translated into a current-state capabilities map.
Also, review/map the current state IT landscape, and document the capabilities/functionality.
Step 3: Define the Future State
After documenting the systems and processes that are in place, one will be able to determine gaps within desired capabilities.
Once the gaps have been identified, I like to work with teams to identify solutions to these gaps. These solutions may involve the implementation of a new system or the adoption/modification of a business process.
Step 4: Strategy and Roadmap
Following this capability-centric approach will help your organization ensure that you have the correct processes, people, and tools/systems in place to deliver on your organizational strategy.