The State Of Digital Excellence In The Global Pharmaceutical Industry, 2023: Clinical Operations

Executive Summary

For the second year, DT Consulting assessed the state of digital excellence (DX) in clinical operations at the world’s largest pharmaceutical firms by surveying 18 senior clinical ops leaders. Analysis of the data reveals that the industry’s overall digital maturity, while still good, has not progressed over the past year. Most pharma firms have substantially shifted their priorities towards clinical research sites and now consider clinical trial experiences as a top component of digital strategy success. The view is a bit different at best-in-class companies, which continue to focus on internal enablement. Firms also reported difficulties in financially sustaining long-term digital initiatives. To navigate these challenges, firms should explore collaborative solutions, share best practices, and strategically address financial hurdles by balancing quick wins with long-term projects.

Challenges to Sustaining Digital Transformation in Clinical Research

In 2023, the pharmaceutical landscape saw a significant increase in clinical innovation, with the US Food and Drug Administration approving 55 new drugs—in recent decades second only to 2018’s 59 approvals.[i] Apart from exciting developments in drug creation, 2023 ushered in a new era of groundbreaking digital trends and big technological leaps such as the rapid introduction of digital measures and the rise of (generative) AI in clinical trial processes, each of which has the potential to transform the industry and the customer experience (CX) it delivers.[ii] But these promising advances also create new challenges for pharma firms and their clinical ops teams, which need to adapt rapidly to a changing digital landscape. Our most most-recent survey shows that senior leaders of large pharmaceutical organizations are under mounting pressure to adopt and integrate these digital solutions and stay competitive. In the past year, they have: 

  • Prioritized data-driven decision-making as a key success factor for digital strategies. The DX/CX imperative assumes a direct relationship between a firm’s investment in and progress toward digital excellence maturity and the customer value it creates. While senior leaders saw a clear DX/CX imperative in 2022, they are now prioritizing data-driven decision-making as a key success factor of their digital strategy (see Figure 1). In 2022, all senior leaders cited improving patient access to research and increasing diversity and inclusion as a main objective of their clinical trial digital strategy—but just 20% said the same in 2023. In contrast, delivering better patient experiences was one of the objectives most often cited in both years. In 2023, more pharma companies say that they have specific leadership positions for patient experiences and decentralized approaches than in 2022 (see Figure 2).
  • Defined a digital transformation vision and strategy but think it will take time to achieve. In 2023, the percentage of senior leaders saying that their organization has a clearly defined vision and strategy for digital transformation in clinical trials rose from 75% to 83%; those that lack a strategy are working on defining one (see Figure 3). All this year’s respondents say that they either have aligned this strategy with other areas, such as medical affairs and commercial operations, or plan to do so, a sharp increase over 2022. On a less positive note, 80% of leaders believe that they can achieve their strategy and digital transformation plans within five years; the remainder think it will take longer. This is a significant shift from 2022, when all leaders surveyed believed that their strategy was achievable within five years.
  • Had difficulty securing budget for sustained implementation of digital capabilities. Nearly half of senior leaders say they face budget challenges with implementing digital capabilities in clinical operations (see Figure 4). And it seems that help is unlikely to arrive soon: 69% expect their digital transformation budgets to stay flat or decrease next year. Although most firms dedicate budget to clinical ops digital transformation projects, the percentage that don’t almost tripled. The digital plans that pharma firms implemented in response to COVID-19 are waning: 33% of senior leaders indicated that those plans are no longer in place at their company (see Figure 5). There was little to no change in the implementation of environmentally friendly digital strategies.
  • Struggled to provide enough resources to enhance employees’ skills.
    Nearly half of clinical ops leaders say that more than 10% of their global team members have specific expertise in clinical trial digital capabilities or transformation; four in five are currently actively recruiting digital experts (see Figure 6). However, training resources are a challenge: less than half of firms provide enough learning tools and training time to current and new employees alike.

[i] Source: “Advancing Health Through Innovation: New Drug Therapy Approvals 2023”, US Food & Drug Administration Center for Drug Evaluation and Research (https://www.fda.gov/media/175253/download?attachment).

[ii] Source: “Using Artificial Intelligence & Machine Learning in the Development of Drug & Biological Products”, US Food & Drug Administration (https://www.fda.gov/media/167973/download?attachment)

Figure 1: Enabling data-driven decision-making is the most important digital success factor

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Figure 2: Pharma firms anchor patient experience success in senior leadership positions

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Figure 3: Most companies have a defined digital strategy

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Figure 4: Despite its criticality, most companies face budget challenges to sustain digital projects

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Figure 5: Most firms are on the road to digital transformation, but environmental awareness is still mixed

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Figure 6: Global clinical ops teams face a significant gap in digital skills, despite working to address it

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The Digital Maturity Excellence of Clinical Operations Has Stalled

In 2023, we again applied our Digital Excellence Maturity Assessment (DEMA) framework to clinical ops organizations to determine the maturity of essential digital capabilities in clinical trial processes.[i] The new survey involved 18 pharma companies, six more than in 2022, and assessed three new digital capabilities—digital measures, clinical trial risk management, and clinical trial transparency and data-sharing—bringing the total to 14 (see Figure 7). Of these 14 capabilities, eight involve external engagement channels that directly affect interactions with clinical sites or participants, whereas six are internal. Our 2023 benchmark indicates that: 

  • Overall digital maturity remains good. The average digital maturity excellence score in pharma clinical ops is 57—the same as in 2022 (see Figure 8). This score qualifies as good, but it’s near the bottom of the range and is far closer to fair than it is to excellent. Nine companies received good scores; two scored as excellent. While this is promising, there was a lot of variability in the rankings, with six firms receiving fair or poor scores. The lowest-ranked company scored 23—in the poor range and a massive 66 points below the best in class.
  • Trial site-facing digital capabilities have attained excellence and have the most promise. Site selection, feasibility, and site startup are the three most mature capabilities in 2023, all receiving excellent scores (see Figure 9). The maturity of these three capabilities has increased sharply as senior leaders focus more on clinical sites, as other survey insights confirm. Global strategies aimed at enhancing clinical sites’ digital capabilities are a priority (see Figure 10) and the experience of both clinical sites and patients are now key factors underpinning clinical ops digital strategy (see Figure 11). Notably, this year also saw a sharp increase in budgets allocated to clinical trial sites (27% to 50%).
  • Best-in-class companies prioritize the basics. At the top five firms, most capabilities are excellent, with none scoring below good (see Figure 12). The most mature capability for best-in-class firms remains patient data capture, indicating that clinical ops organizations are making a long-term commitment to sustaining digital priorities. The greatest maturity advantages that top performers have over the rest of the industry all relate to behind-the-scenes capabilities or internal capabilities that optimize clinical trial processes and data usage. In addition to patient data capture, these are automation, clinical transparency and data-sharing, clinical trial risk management, and analytics.
  • Digital maturity correlates with adoption. We found that clinical ops teams are more likely to adopt mature digital capabilities (see Figure 13). However, this correlation does not hold for other factors and adoption drivers, such as perceived clinical trial process efficiency and ease of implementation. These results suggest that when technologies are effectively supported by skilled people and optimal processes, adoption rates improve substantially—so enhancing maturity scores could be pivotal to achieving clinical trial excellence faster. Adoption was lower than expected for some patient-facing capabilities including recruitment, and screening and consent (see Figure 14).

[i] Source: DT Consulting, “The State of Digital Excellence In The Global Pharmaceutical Industry, 2022: Clinical Operations”, November 22, 2022 (https://dt-consulting.com/the-state-of-digital-excellence-in-the-global-pharmaceutical-industry-2022-clinical-operations/).

Figure 7: Core capabilities required to lead digital transformation in clinical operations

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Figure 8: The state of digital excellence in the global pharmaceutical industry, 2023: clinical operations

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Figure 9: Clinical site-facing capabilities perform best

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Figure 10: Clinical ops are adopting global strategies for the digital transformation of clinical trial sites

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Figure 11: Clinical site experience is the key factor for all senior leaders

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Figure 12: Top companies outperform the industry on behind-the-scenes capabilities

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Figure 13: Digital maturity correlates with internal adoption rates

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Figure 14: There is significant variation in the adoption of digital capabilities

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Key Gaps in the Pharma Industry’s Organizational Readiness

To understand the pharmaceutical industry’s progress in clinical trial digital transformation, we looked at another key factor: the organization’s readiness to design and execute a program of internal initiatives to increase digital excellence maturity. Organizational readiness includes planning, leadership, assessment, implementation, and resourcing and is key metric to assess whether firms are prepared to pursue digital excellence. The assessment of organizational readiness is a crucial tool to gain insights into the groundwork essential to a successful digital transformation; it reveals non-technological aspects of the organization that may affect innovation processes, highlighting gaps and potential pitfalls. For the 18 pharma firms in our study, we calculated the organizational readiness score—a composite of 17 critical components of a company’s digital transformation effort—and found that:

  • Organizational readiness is good on average. In 2023, the average organizational readiness score is 63 (see Figure 15). Five firms are in the excellent zone, but nine are stuck in the good zone, three in the fair zone, and one in the poor zone. Most of the firms are below the industry average, with a significant gap between leaders and laggards, indicating that there are one or more organizational factors hindering digital maturity progress. Given that the industry has made no progress on its overall digital maturity, firms need a score in the excellent zone here to increase it.
  • Leaders recognize the need for digital talent and support their ideas. The organizational readiness assessment makes it clear that the company recognizes the pivotal role of digital talent in digital transformation success (see Figure 16). Talent and buying into the need for transformation are the two top contributors to organizational readiness, both receiving excellent scores. This attests to leadership’s proactive stance in fostering an environment that both values the importance of acquiring digital skills and actively supports innovative ideas from within the workforce. Robust support from leadership encourages the cultivation of digital expertise and sets the stage for a collaborative, forward-thinking organizational culture.
  • Clinical trial organizations embed patient and site customer centricity into their culture. The average customer centricity score of 70—not far from excellence—show that a customer-centric approach is deeply ingrained within the culture of clinical trial organizations. Customer centricity extends beyond traditional boundaries to encompass both patient and clinical sites. A strong emphasis on customer centricity enhances an organization’s overall adaptability and ensures that digital transformation efforts align seamlessly to the diverse and evolving requirements of patients and clinical stakeholders. It indicates a culture that prioritizes agility and responsiveness to evolving clinical landscapes.
  • The industry lags in execution. The assessment reveals an industry with low organizational readiness for execution elements—such as capabilities, benchmarking, and operating models—that are the bedrock of successful digital project execution. This is a red flag. The lack of local investment in resources, capabilities, and operating models forms a substantial roadblock to progress towards digital excellence at scale. This organizational shortfall hinders the industry’s ability to embrace emerging technologies effectively and jeopardizes its competitiveness in a rapidly evolving digital landscape. Addressing these deficiencies and focusing on strengthening execution elements is imperative for the industry to overcome these roadblocks and advance its digital maturity.

The Change Management Challenges Of Clinical Trial Digital Transformation In 2023

When we asked senior leaders about the most prominent execution and change management challenges in clinical trial innovation, their answers were similar to those related to organizational readiness. Senior leaders tell us that:

  • Defining the effectiveness of digital strategy is particularly difficult. One-third of senior leaders say that defining the effectiveness of digital strategies within clinical trial organizations is their most significant obstacles to success. They struggle to establish clear and measurable key performance indicators (KPIs) for their digital transformation processes. The dynamic and evolving nature of clinical trial innovation makes it even more difficult to establish static benchmarks. The absence of well-defined KPIs impedes senior leaders’ ability to gauge the impact of their digital strategies accurately. Addressing this challenge requires a nuanced approach involving collaboration between stakeholders to identify and refine metrics that align with overarching digital transformation goals.
  • Embedding new technology into existing clinical ops is the most common challenge. The leaders we surveyed most often cited technology complexity as a key challenge (see Figure 17). Complexity arises from the need to adapt established processes and workflows to accommodate cutting-edge digital tools and solutions. Just implementing the technology is not enough; the challenge is to align these innovations with the operational complexities of clinical research and includes factors such as regulatory compliance, data security, and the interoperability of new tech with existing systems. Successfully overcoming this challenge demands a comprehensive strategy that involves not only the deployment of advanced technologies but also the meticulous evaluation and adaptation of operational frameworks to ensure a harmonious integration.

Figure 15: Organizational readiness in pharma firms’ clinical operations

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Figure 16: Execution elements are at the low end of the organizational readiness spectrum

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Figure 17: Technology complexity is the most widespread challenge to clinical trial innovation

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Innovation Leaders Must Balance Long-Term Projects With Quick Wins

In the rapidly evolving landscape of clinical trial innovation, the pharmaceutical industry is on the cusp of transformative digital possibilities. As the pursuit of digital excellence becomes imperative, senior leaders face a delicate balancing act. Managing competing priorities for immediate wins and long-term strategic initiatives is paramount for sustained success as well as the tenure of global clinical trial business capabilities teams. To stay competitive and deliver internal value, senior clinical ops leaders should:

  • Prioritize quick wins with long-term impact. Conduct a comprehensive audit of ongoing projects to identify opportunities for quick wins that align strategically with the long-term digital vision. Prioritize initiatives that have immediate impact but also contribute synergistically to broader transformation goals. This audit enables a strategic assessment of ongoing projects and helps identify areas where clinical ops can achieve quick and secure funding without compromising long-term objectives.
  • Set smart KPIs. Measuring a digital project’s impact is key to the success of any implementation—but our data indicates a troubling lack of standards here. Engage key stakeholders, including data analysts, clinical ops teams, and digital experts, to collaboratively define KPIs that align to the evolving landscape of clinical trial innovation. Implement a dynamic dashboard that enables you to track these KPIs in real time and adapt them as needed. Real-time dashboards provide visibility into the effectiveness of strategies, allowing for prompt adjustments. Not having this in place exposes the risk of perceived value coming out of global digital capabilities teams.
  • Enhance cross-functional collaboration. Institute regular cross-functional workshops and collaborative forums to encourage open communication, best-practice sharing, and idea exchange. Implement shared digital platforms to facilitate real-time collaboration and ensure that digital strategies seamlessly integrate across diverse organizational functions. Collaboration is essential to fostering a unified approach to digital transformation, ensuring that strategies are collectively embraced and implemented. Cross-functional task-force collaboration has been the key to innovation success in other sectors, and pharma should encourage it as well.
  • Invest in talent and local resources for execution. Analyze the skill gaps on local teams and allocate resources for targeted training programs. Establish local digital innovation hubs to encourage a culture of continuous learning and collaborative problem-solving. Investing in local talent addresses specific skill gaps, ensuring that teams are well-equipped to tackle digital challenges. Innovation hubs foster a culture of adaptability, allowing teams to contribute actively to successful project execution.

Methodology

The Clinical Trial Digital Excellence Maturity Assessment (CT DEMA) methodology is based on a proprietary framework of DT Consulting and was optimized in collaboration with a group of selected clinical ops senior leaders. DT fielded its 2023 The State of Digital Excellence in the Global Pharmaceutical Industry survey to global senior leaders of clinical trial digital and innovation inside 18 large to midsize pharmaceutical organizations from May to October 2023. Respondents received a copy of this report containing the collected survey data prior to publication. The sample is not guaranteed to be representative of the population and responses do not convert directly into precise maturity scores for respondents’ respective companies. Unless otherwise noted, data is intended for descriptive purposes.

Related Research

Companies Researched In This Report

AbbVie, Amgen, Astellas, Bayer, Boehringer-Ingelheim, Bristol Myers Squibb, Genentech, Gilead Sciences Inc, GlaxoSmithKline, Johnson & Johnson Innovative Medicine, Novartis, Novo Nordisk, Otsuka, Pfizer, Regeneron, Sanofi, Sun Pharmaceuticals, UCB

Acknowledgements

The CT DEMA methodology and this white paper were developed in collaboration with the DT Clinical Trials Leadership Board, involving 25 senior clinical operations leaders of large pharma companies. This included active contributions by Craig Lipset, Clinical Innovation Partners, and Nicole Sheetz, Gilead Sciences Inc.

Authors

Francesca Properzi crc

Francesca Properzi

Director

Francesca has more than ten years of experience in life science and healthcare research projects, including frontline scientific research, digital transformation, and innovative technologies. As Director of Research, she steers the DT thought leadership team to generate valuable insights into customer experiences in the clinical and medical affairs areas of the biopharmaceutical value chain.

Tim van Tongeren

Managing Partner

For more than fifteen years, Tim has worked with commercial leaders to navigate their strategic and organizational transformations required to thrive on digital technology change. In his current role as Managing Partner, he leads DT’s Solutions and Consulting offerings to advise the world’s largest pharmaceutical firms on how to best achieve customer experience success through digital transformation. He also directs DT’s ongoing effort to provide the pharma industry with the most relevant insights on digital strategy, digital health, and organizational change.
Tim van Tongeren crc

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