November 22, 2022
The State of Digital Excellence In The Global Pharmaceutical Industry, 2022: Clinical Operations
Executive Summary
The Organizations Behind Digital Transformation in Clinical Ops
Digital technologies help clinical operations organizations address opportunities and challenges with recruitment, patient enrollment, study design, protocol compliance, safety reporting, and participant trial engagement. To design and manage superior experiences for clinical trial participants, pharmaceutical companies must systematically build and improve their digital capabilities and associated operations.[i] To understand how drug development organizations are adapting to digital transformation, we surveyed twelve senior VP-level leaders at major pharma firms who have digital transformation in their remit and found that:
- Not all see the DX/CX imperative, but most have a leadership position covering it. Nearly all respondents say that optimizing the customer experience (CX) for trial participants and investigators is very or extremely important (see Figure 1). However, just half of them make CX a main objective of their digital transformation and digital excellence (DX) efforts, instead prioritizing patient access to clinical research and speeding up drug approval (see Figure 2). While eleven of the twelve respondents report that digital transformation is in the remit of one of their senior leaders, just eight report having a leadership position specifically dedicated to patient experience (see Figure 3).
- Most have a defined vision and strategy for digital transformation. Most senior leaders say that their organization has a clearly defined vision and strategy for digital transformation in clinical trials; those that don’t are working on setting a strategy (see Figure 4). Most have aligned this strategy with other areas, such as medical affairs and commercial operations, or plan to do so. All twelve believe that they can achieve their strategy and digital transformation plans within five years; eleven have already taken specific steps towards digital transformation and change management.
- Digital transformation budgets don’t clearly align with strategic objectives. While most firms have dedicated budget to digital transformation projects, just half dedicate budget to patient experience improvement even though they say it’s very important (see Figure 5). In addition, only 30% of the companies have allocated budget to support clinical trial sites with digital technologies.
- Companies give employees training due to a lack of digital talent. Most senior leaders say that they are providing both new and existing staff with enough or more than enough training tools (see Figure 6). One-third of senior leaders believe that more than 20% of their people have the right skills to adopt digital technologies (see Figure 7). Almost all senior leaders use talent acquisition as a tactic to get more digital skills into their organizations faster.
[i] Pharmaceutical firms can realize significant benefits from holistically understanding and supporting the entire patient journey and using digital technologies to improve patient recruitment, retention, and adherence. See the February 15, 2021 report “Defining The Capabilities Required To Attain Digital Excellence In Clinical Trials”.
Figure 1: Improving the clinical trial experience of patients and investigators is critically important
Figure 2: Better patient access and faster new drug approval are key to the success of digital strategy and vision
Figure 3: Better patient access and faster new drug approval are key to the success of digital strategy and vision
Figure 4: All pharma companies will soon have defined a vision and strategy for digital transformation
Figure 5: Despite its criticality, half of companies lack a specific budget to improve trial participants’ experiences
Figure 6: Current and new employees of large pharma companies are equipped to use new digital tools
Figure 7: Clinical ops teams need to focus on improving the digital skills of new hires and current staff
Digital Excellence in Clinical Operations is a Mixed Bag
As the clinical operations organization evolves to embrace the digital excellence opportunity, so does its digital excellence maturity. We define “digital excellence” as the extent to which an organization adopts a series of digital capabilities to benefit clinical trial experiences. To determine how mature the most essential digital capabilities are in the life sciences industry, we applied our Digital Excellence Maturity Assessment (DEMA) framework to clinical operations organizations in large pharma firms for the first time. The DEMA framework:
- Uses a maturity model to assess key clinical ops digital capabilities. DEMA evaluates firms’ ability to apply digital technology to end-to-end study execution and the participant experiences that result. Six capabilities relate to study design and planning and five relate to study conduct; each plays a specific role in the trial process and has a set of practices associated with it (see Figure 8). The assessment is comprised of a total of 119 practices categorized into tiers of complexity. Higher-tier practices are more complex, more difficult to perform consistently, and typically depend upon prerequisite practices in lower tiers (see Figure 9). For example, enabling a website point of contact is a core practice in patient recruitment, but using AI and natural language processing to find patient matching eligibility criteria is an advanced practice.
- Has leaders review and rate their adoption of best practices underpinning each capability. Armed with the maturity model, we fielded an online survey to senior clinical ops leaders at twelve large global pharmaceutical companies. Together they form a working group to validate the approach and stimulate collaboration across the industry to share lessons learned about digital transformation in clinical trials and develop guidelines, tools, and best practices.
- Scores maturity based on overall capability creation and adoption. For each of the eleven key digital capabilities, we asked senior leaders to identify practices that their organizations deliberately and consistently follow. Each firm’s digital capability maturity score is determined by the number of practices that they observe their organizations using. A firm that uses half to three-quarters of these practices ranks as “good” digital maturity; anything above that is considered “excellent” maturity—the sweet spot for any company and the zone in which the DX/CX imperative comes to fruition.
Figure 8: Core capabilities required to lead digital transformation in clinical operations
Figure 9: Sample practices as part of a core capability and their tiers of complexity: patient data analytics
Clinical Ops Digital Maturity Varies Significantly Across Large Pharma Companies
We surveyed our panel of senior leaders in global pharma clinical operations in April and May 2022. Applying the DEMA methodology to the responses shows that:
- The industry’s digital excellence maturity score is fair. Self-reported maturity covers a wide range, from 83 all the way down to 36 (see Figure 10). This suggests that many companies struggle to align their program of capability building with their strategy and vision. Three firms rated their maturity as excellent; such firms can provide welcome insights to the industry as to how to structure and manage a transformation program.
- Digital patient experience and automation tools are the least mature capabilities. While some firms rate their maturity as excellent, neither the industry as a whole nor any individual capability is. The average maturity of nine capabilities is good, most notably site selection and data capture tools and technologies (see Figure 11). Patient experience tools and automation platforms are the lowest ranked, yet still in the “fair” zone.
- Leaders and laggards succeed and struggle the most with the same capabilities. The most digitally mature firm attains excellence in most capabilities, but particularly outpaces the industry in three areas: data capture technology, study design, and participant experience tools (see Figure 11). In contrast, the gap between best-in-class and the industry average is the smallest for site selection tools, recruitment capabilities, and automation.
- The maturity of capabilities correlates to their rate of adoption. While most companies already have global strategies for each of the 11 digital capabilities in place or are working on implementing them, adoption rates are still low (see Figure 12). Only four capabilities have been adopted by more than half of clinical trial teams (see Figure 13). The more mature a capability is, the more clinical trial teams adopt its practices (see Figure 14).
What Holds Companies Back From Accelerating Towards Digital Excellence?
Most senior clinical operations leaders are positive about the impact that each individual digital capability has on trial participant engagement and study execution (see Figure 15). However, they also report roadblocks that hinder their progress towards digital excellence:
- The complexity of embedding new technologies in existing clinical operations. When we asked respondents to highlight the top three challenges to achieving digital excellence in clinical trials, they most often cited the complexities of implementing and using digital technologies and getting the right resources to enable digital transformation (see Figure 16). Fewer respondents are concerned about selecting the right technology vendor or regulatory and compliance issues around specific digital technologies.
- Getting internal change right. Other key obstacles to digital transformation are related not to technology and process, but to another fundamental component of digital transformation: people and change. Four of the twelve leaders find it a challenge to ensure that clinical trial teams adopt new technology and to gain internal alignment among key stakeholders; three leaders find it a challenge to define an effective strategy to achieve digital excellence internally. But overall, clinical operations organizations are much readier to undertake digital transformation and less worried about cultural change than those in commercial operations.[i]
[i] Organizational readiness—which encompasses planning, leadership, assessment, implementation, and resourcing—is a key metric to assess whether firms are prepared to pursue digital excellence. However, the industry appears to be less ready for digital transformation in 2021 than it was in 2018: pharma companies are evenly split between digital leaders and digital laggards. See the January 20, 2022 report “The State Of Digital Excellence In The Global Pharmaceutical Industry, 2021”.
Figure 10: The state of digital excellence in the global pharmaceutical industry, 2022: clinical operations
Figure 11: Whether you’re leading the industry or not, some capabilities are difficult to get right
Figure 12: Companies are adopting global strategies to integrate digital capabilities into clinical trial processes
Figure 13: The adoption of digital capabilities needs to grow
Figure 14: Digital maturity correlates with adoption rates
Figure 15: Senior clinical ops leaders are positive about their contribution to improving participant experiences
Figure 16: Change management challenges are slowing down digital adoption by clinical ops teams
Four Key Actions to Drive clinical Ops Towards Digital Excellence
Clinical trial digital capabilities are developing rapidly, and best practices need to evolve accordingly. A key competitive differentiation will be to integrate the voice of the patient in all clinical trial processes and align stakeholders with clinical ops teams across regions and therapy areas in doing so. To stay competitive:
- Include patients in your best practices from the start. Best-in-class firms include participant feedback in their digital capability best practices, starting from study design and preliminary trial stages for protocol optimization. Hybrid and fully decentralized trials are making it increasingly important to identify patient needs and expectations to avoid poor recruitment rates or patient disengagement during the course of the study.
- Align budget, skills, and talent. The first step in making your clinical trial future-ready is to assess trial costs and reallocate budget to support decentralized, patient-centric approaches. To thrive, look at firms with best-in-class CX not only in the pharma industry, but also in sectors like media, retail, and travel. These companies budget more for data analysis, digital technologies, skills, and talent dedicated to improving their knowledge of customer behavior and act accordingly.
- Close the digital efficiency and effectiveness gap. Among digital technologies, only patient data capture tools are effective at improving clinical trial processes; notably, these are the most mature, the most used, and the best supported by global strategies. The more that all participants, including trial sites, adopt and use technology, the more efficiently those technologies deliver process improvements. Successful adoption also requires a strategy for compatibility and integration with different digital platforms to optimize data flow and usage.
- Establish effective change management processes. Large clinical trial organizations have teams working in a variety of geographies and functional areas; this makes managing change a significant challenge. A successful change strategy identifies accountable senior leaders and engages the teams responsible for key processes at the right time. To implement changes, you need tangible KPIs and visibility into the results obtained. When adopting new technologies, apply iterative design thinking processes that focus on collaboration between developers and users.
Postscript: Concern About Digital Transformation’s Effect On The Environment
Ten of the twelve senior leaders we surveyed think that the COVID-19 pandemic accelerated the digital transformation of clinical operations (see Figure 17). Most firms adapted their capabilities’ processes in response to COVID-19 (see Figure 18). Clinical trials’ carbon footprint and new environmental requirements related to digital adoption are much on senior leaders’ minds. Most companies are focusing on an environmentally friendly digital strategy, which includes activities like the disposal of single-use digital trackers and integration of the exposome. Sponsors are proposing to systematically review and confirm whether the value of the information gained from a trial justifies the amount of carbon that trial uses. Ideally, sites would estimate the carbon footprint of their trials and find ways to minimize it.
Figure 17: Senior leaders are concerned about their firm’s carbon footprint
Figure 18: The COVID-19 pandemic improved the adoption of most digital tools
Methodology
The 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 2021 The State of Digital Excellence in the Global Pharmaceutical Industry survey to global senior leaders of clinical trial digital and innovation inside 12 large to midsize pharmaceutical organizations from December 2021 to March 2022. 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
- Defining The Capabilities Required To Attain Digital Excellence In Clinical Trials
- The State Of Digital Excellence In The Global Pharmaceutical Industry, 2021
Companies Researched In This Report
AbbVie
Bayer
Bharat Serums and Vaccines
Bristol Myers Squibb
CSL Behring
GSK
Gilead
Janssen
MSD
Otsuka
Pfizer
Sanofi
Acknowledgements
The CT-DEMA methodology and this white paper were developed in collaboration with the DT Clinical Trials Leadership Board, involving 16 senior clinical operations leaders of large pharma companies. This included active contributions by Rakesh Maniar, Executive Director, GCTO at MSD and Jeroze Dalal, Head of Medical & Clinical Operations at GlaxoSmithKline Pharmaceuticals.
Authors
Francesca Properzi
Director
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