Clinical ArchitectureIn 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).

Clinical Trial Activitiy Flow

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.

Clinical Architecture - Strategy Identification

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.

Clinical Architecture - Current State Capability Map

Also, review/map the current state IT landscape, and document the capabilities/functionality.

Clinical Architecture - Current State IT Landscape

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.

Clinical Architecture - Capability Gaps

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.

Clinical Architecture - Future State IT Landscape

Step 4: Strategy and Roadmap

Having a defined future state has no benefit to your organization without an actionable plan to get there. This actionable plan (roadmap) includes the detail for the strategy (step 1) from the vision, goals, and objectives, and business drivers to the proposed solution, the case for action, and ultimately the strategies and key initiatives laid out across a high-level project plan.

Clinical Architecture - 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.

Learn more about our clinical architectural offering or download our whitepaper. We look forward to helping your team prepare for the future.

Creating a Roadmap to Clinical Trial Efficiency