Jason Smith, CTO – AI & Analytics at Within3
In the race to deliver life-saving treatments, pharmaceutical companies face a paradox: they’re awash in data yet struggle to glean actionable insights. In this second installment of our blog series, we explore the current data landscape, spotlighting the challenges that come with regulatory demands, massive data generation, and siloed processes. We’ll then delve into a real-world case study showing how a unified data strategy anchored in clear objectives can spark innovation and foster a culture of seamless collaboration.
Setting the stage: the current data landscape in pharma
The data-rich environment across R&D, clinical trials, manufacturing, and commercial
Pharmaceutical companies produce terabytes of data in a single clinical trial. Expand this to every stage, from research and development to manufacturing and commercialization, and the volume becomes staggering. While this abundance of information holds immense promise, research indicates that nearly 50% of clinical trial data goes unanalyzed, leaving a wealth of potential discoveries untouched.
- R&D insights: Genomic studies, high-throughput screening, and early-stage research generate massive data streams.
- Clinical trials: Patient outcomes, safety metrics, and real-world evidence amass rapidly.
- Manufacturing: Quality control and supply chain data can yield significant efficiencies and cost savings.
- Commercial: Sales trends, market access metrics, and patient feedback complete the lifecycle data picture.
Yet, in many cases, these disparate datasets remain locked within departmental silos, preventing a unified view that could spark new insights and therapeutic breakthroughs.
Siloed data within functions hinders insights and value creation
Despite increasing recognition of data’s strategic importance, cross-functional collaboration remains elusive. A recent study found that 95% of organizations are concerned that a fragmented data system may significantly hamper decision-making. When key findings remain confined to one department, be it R&D, commercial, or manufacturing, the organization as a whole misses out on the powerful synergy that can emerge when diverse data streams are integrated.
- Duplication of effort: Departments might unknowingly repeat analyses or conduct parallel studies.
- Inefficiency: Time and resources are lost as teams struggle to access vital real-time information.
- Inconsistent practices: Varying data collection and reporting methods make holistic integration even more challenging.
Regulatory pressures and compliance requirements around data
Layered atop these silos are stringent regulations – including FDA, EMA, GDPR, and HIPAA — that demand rigorous data governance. Non-compliance can carry severe penalties, sometimes up to 4% of annual global turnover. In an environment where reputation is paramount, ensuring data privacy and integrity isn’t just about avoiding fines; it’s about maintaining the trust of patients, healthcare providers, and regulators.
- High stakes: Regulatory infractions can lead to halted trials, delayed approvals, or restricted market access.
- Strategic opportunity: Robust compliance practices can serve as a differentiator, showcasing an organization’s commitment to transparency and patient safety.
A real-world success story: establishing a unified data strategy
While the challenges are significant, forward-thinking pharmaceutical companies are making headway. They adopt a unified data strategy that spans technology, processes, and governance to drive meaningful, enterprise-wide insights. Below is a case study demonstrating how a methodical, cross-functional approach can yield measurable gains.
Defining key insight topics (KITs) and key insight questions (KIQs)
Many organizations collect data without a clear vision of its intended purpose. The first step in this case study was pinpointing KITs: strategic themes that guide data collection, and KIQs: the specific, decision-driving queries linked to those themes.
- Tangible alignment: Mapping KITs and KIQs to crucial drug development milestones helped streamline efforts, ensuring data collection directly supported business objectives.
- Measurable impact: Focusing data initiatives on these carefully defined KITs and KIQs reduced development costs by up to 30% as teams moved in lockstep rather than duplicating work.
Implementing integrated evidence planning (IEP)
After clarifying its strategic priorities, the organization introduced integrated evidence planning, or IEP: a holistic approach synchronizing evidence-generation initiatives across functions like R&D, medical affairs, commercial, and regulatory.
- Breaking down silos: Cross-functional steering committees used a shared SaaS platform to track progress, share insights, and coordinate trial designs.
- Accelerated timelines: Harmonizing these efforts led to a 25% reduction in time-to-market for new drugs. Data flowed seamlessly from early-stage research into real-world settings, bypassing bottlenecks and redundant approvals.
Results: A cohesive, purposeful approach to data
This organization reported a 20% increase in operational efficiency by adopting a unified data strategy. I also fostered a cultural shift: teams began to view data as a shared asset rather than an individual departmental resource.
- Greater transparency: Leaders gained the ability to make faster, evidence-based decisions.
- Enhanced compliance: A centralized governance model facilitated alignment with global regulations, mitigating the risk of costly infractions.
- Stronger collaboration: Consistent data standards and integrated workflows fostered a spirit of partnership and collective accountability.
Looking ahead
Data can transform the pharmaceutical industry, but only if it’s harnessed with intention, coordination, and robust governance. By defining key priorities through KITs and KIQs, implementing IEP and fostering a culture of collaboration, pharma companies can unearth new opportunities hidden in the mountains of data they generate.
In our next blog, we’ll explore how emerging technologies, particularly AI and digital collaboration tools, amplify the benefits of a unified data strategy. If the challenges of compliance, siloed systems, and data overload sound familiar, consider this your call to action: Invest in a thoughtful, enterprise-wide approach that merges strategy with technology to create a strong, patient-centric impact.
Want to learn more? Join us at Reuters Barcelona 2025. I will discuss how to use “Cross-Functional Data Collection to Reinforce Value Creation and Insight Generation.” Listen, set a Braindate, or stop by Booth #28 to chat with me and the Within3 team.
