Enhancing Efficiency and Time-to-Market in Clinical Trials and Drug Development

Background

A global pharmaceutical giant, leaders in the care of diabetes, obesity and other chronic diseases had the vision to be a Top 5 player in clinical trials and drug development by 2025. As a first step, they needed to understand the best-in-class market standards today and where they stand in terms of operational processes, technology platforms/infrastructure and digital capabilities.

Bringing a new drug to market involves a complex web of processes cutting across stakeholder groups. 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.

The goal was to increase the efficiency and velocity for research, development, and launch, making the new therapies more affordable and accessible to patients and providers at the earliest time possible.

In the past, the company had engaged large consulting companies to adopt best-in-class drug development processes which did not result in actionable plans. Altimetrik was engaged based on expertise in data sciences and deep domain knowledge, and a proven track record of delivering an outcome-based digital business solution.

Challenge

The client executed a number of complex processes – interconnected, but operationally self-contained leading to several process and information silos. The first step was to organize these processes under seven standard areas to cover the full value chain, which are:

1. 1. Trial Initiation
2. 2. Patient Enrollment/Engagement
3. 3. Visit Management/Data Capture
4. 4. Trial Supply Logistics
5. 5. Results Analysis
6. 6. Submission & Closure
7. Follow Up

The client’s processes were not organized around this value chain which implied the need to analyze organizational silos by breaking up their current structure into sub-processes and then casting them back into a standard value chain.

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Outcome-led Solution

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

A 6-week study was conducted by Altimetrik practitioners that delivered an end-to-end analysis while benchmarking against four global competitors.

The study identified 36 sub-processes which existed as a part of different organizational groups, often cross-linked to various parts of the value chain. The next step was to uncover the pain points between the seven areas and the friction points between the 36 sub-processes through SME interviews, technology stakeholder discussions, and inputs from executive leadership and their direct reports.

The assessment provided the client with 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 ability to share information seamlessly

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

The As-Is Assessment Strategy

Qualitative Measurement
Around 50 one-hour long interviews were conducted with SMEs, process owners, IT stakeholders, and executive leaders to assess user needs and expectations, identify potential opportunities for process improvement, detect hidden sources of friction, and gauge organizational readiness for change. These also gave an indication about the clarity with which the leadership vision and goals were cascaded across the development organization, extracting perspectives on IT strategy, current platforms, and the technological needs of process owners. Industry knowledge and best practices as well as existing strengths within the company were used to identify systemic and process improvement opportunities. From a user perspective, the qualitative measurements also examined specific pain points and wish lists of process owners along with their vision and interpretation of what it meant to be a best-in-class digital organization.

Quantitative Measurement
Facts and insights gleaned from the interviews were used to score each of the 36 sub-processes (on a 10-point scale) against four parameters of maturity:

1. Process Friction
   How smoothly, repeatably, and predictably does the process operate?
2. Process Measurement
   Was the organization able to measure each sub-process for the quality, timeliness, efficiency, and velocity?
3. Use of Data
   Understanding the use of data within an organization—access, consumption, sharing—has a profound bearing on the value of data as an asset and the ROI it delivers. Was there a scope to improve the use of data by adopting digital instead of manual techniques?
4. Leveraging Digital
   Effective use of digital technologies in clinical development is about making processes flexible, responsive, aware, and resilient.

Simultaneously, a dipstick study was done with data from the last 25 clinical trials, but the information did not capture the details needed to measure efficiency or velocity of processes as well as 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 they were not capturing and sharing much of the information relevant to driving efficiency and process quality. Besides, there was a disconnect between process-to-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:

1. Feedback analysis and opportunity identification
2. Aggregated classification
3. Process scoring and heatmaps
4. Platform capabilities
5. Ongoing initiatives
6. Potential opportunities

Scorecard
A scorecard based on an easy comparison with industry leading pharma majors on the four parameters was presented to understand the organization’s maturity level. The client could use the scorecard to see where they were strong and where they needed to improve. It also indicated the extent of deviation in maturity levels against the top pharma majors along with reasons that ranged from an integration gap to the lack of automation, lack of standardization, poor integration with upstream processes, etc.

Heatmaps
Additionally, heatmaps of the 36 processes across the four parameters further broke down the opportunities for improvement, flagging them as limited, medium, and significant, and then prioritizing these actions further based on ROI and feasibility.

Delivering Actionable Roadmap

The final analysis and report concluded by providing high-level ideas and action plans while leveraging existing organizational strengths and investments. Several sound decisions on platform investments had been made in the past, but they were implemented without sufficient focus on ROI and were not being leveraged fully.

Some illustrative examples of the ideas and 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