A Global Pharmaceutical Leader Benchmarks 36 Sub-Processes Across the Clinical Trial Value Chain in a 6-Week As-Is Assessment

A global pharmaceutical giant, a leader in the care of diabetes, obesity and other chronic diseases, held the vision of becoming a Top 5 player in clinical trials and drug development by 2025. First it needed to understand best-in-class market standards and where it stood on operational processes, technology platforms and digital capabilities. Earlier engagements with large consulting companies had not resulted in actionable plans.

Altimetrik ran a six-week as-is assessment, organizing the client’s work under seven standard value-chain areas, scoring 36 sub-processes against four parameters of maturity and benchmarking the organization against four global competitors. The output was a scorecard, heatmaps and an actionable roadmap built on the client’s existing strengths and investments.

The client executed a number of complex processes, interconnected but operationally self-contained, which left it with several processes and information silos. Those processes were not organized around the clinical trial value chain, so the current structure had to be broken into sub-processes and cast back into a standard value chain.

Bringing a new drug to market involves a complex web of processes cutting across stakeholder groups, and friction between sub-processes typically costs the industry tens of billions every year. Delayed time-to-market results in escalating costs and the risk of missing market opportunities.

Altimetrik strategized an as-is assessment study of processes to dive deep into them and identify areas to improve time-to-market, a critical factor in successful drug research and development. The programme also ran a reality check of management intent versus organizational readiness for change, and stitched processes end-to-end in a manner that improves business outcomes.

A six-week study by Altimetrik practitioners delivered an end-to-end analysis while benchmarking against four global competitors. The first step was to organize the client’s complex processes under seven standard areas covering the full value chain.

The study identified 36 sub-processes that existed as part of different organizational groups, often cross-linked to various parts of the value chain. Pain points between the seven areas and friction points between the 36 sub-processes were then uncovered through SME interviews, technology stakeholder discussions and inputs from executive leadership and their direct reports.

The assessment provided insights around

• Transaction platform choices and their alignment with industry best practices
• Process and digital maturity compared to the competition
• Process friction points and the underlying reasons for the friction
• Gaps in infrastructure such as the lack of a single source of truth and the ability to share information seamlessly

The As-Is Assessment Strategy

Qualitative measurement

Around 50 one-hour interviews were conducted with SMEs, process owners, IT stakeholders and executive leaders to assess user needs and expectations, identify opportunities for process improvement, detect hidden sources of friction and gauge organizational readiness for change.

• Clarity with which leadership vision and goals had been cascaded across the development organization
• Perspectives on IT strategy, current platforms and the technological needs of process owners
• Systemic and process improvement opportunities, drawn from industry knowledge, best practices and existing strengths within the company
• Specific pain points and wish lists of process owners, and their interpretation of what a best-in-class digital organization looks like

Quantitative measurement

Facts and insights from the interviews were used to score each of the 36 sub-processes on a 10-point scale against four parameters of maturity.

A dipstick study was run in parallel on data from the last 25 clinical trials. The information did not capture the detail needed to measure efficiency or velocity, or the chain of impact tied to delays and failures, indicating all was not well. The client was not getting real-time insights because processes were siloed and much of the information relevant to efficiency and process quality was neither captured nor shared. There was also a disconnect between process groups, and a gap between IT and business: business was implementing solutions without IT being aware, and IT roadmaps were not aligned to business needs.

Gleaning Meaningful Insights

The output from the study and analysis comprised feedback analysis and opportunity identification, aggregated classification, process scoring and heatmaps, platform capabilities, ongoing initiatives and potential opportunities.

Scorecard

A scorecard based on an easy comparison with industry-leading pharma majors on the four parameters showed the organization’s maturity level, where it was strong and where it needed to improve. It also indicated the extent of deviation against the top pharma majors, with reasons ranging from an integration gap to lack of automation, lack of standardization and poor integration with upstream processes.

Heatmaps

Heatmaps of the 36 processes across the four parameters broke the opportunities for improvement down further, flagging them as limited, medium or significant and prioritizing the resulting actions by ROI and feasibility.

Delivering an Actionable Roadmap

The final analysis and report concluded with high-level ideas and action plans that leveraged existing organizational strengths and investments. Several sound platform decisions had been made in the past but were implemented without sufficient focus on ROI and were not being fully leveraged. Illustrative recommendations included:

• Defining KPIs at the value stream level, tied to business outcomes
• Creating a common domain taxonomy so all participants could use a common terminology
• End user tooling to maximize operational productivity
• Driving adoption of the common data architecture while structuring teams for autonomy in relation to domain data management
• Building a single source of truth
• Defining standard procedures and tools for use case onboarding and information consumption
• Examining a platform that uses Event Driven Architecture to orchestrate and integrate information and workflows across transactional platforms
• Leveraging Veeva to modernize content generation, management and consumption

Large consulting companies had been engaged before without producing actionable plans. Altimetrik was engaged on the strength of its expertise in data sciences, deep domain knowledge and a proven track record of delivering outcome-based digital business solutions.

As an outsider, Altimetrik was able to drive consensus and facilitate change in the organization, an understated but high-impact benefit of partnering with a strong digital business enabler.