Compliance is not only an obligation but also a strategic asset for modern organizations. It enables them to operate ethically and responsibly, while at the same time protecting their reputation and building and maintaining customer trust.
What can managers do to improve compliance?
Based on a case study in which the Design Science Methodology was applied within a pharmaceutical company, this article describes a “Compliance 2.0” approach for modern, adaptive organizations.
The COVID-19 crisis put the pharmaceutical industry under immense pressure. Manufacturers were forced to deliver effective vaccines much faster than usual, while at the same time all industries were compelled to adopt new forms of consultation and collaboration due to COVID restrictions. Although the pharmaceutical sector is renowned for its innovation and adaptability, it is also one of the most heavily regulated industries worldwide when it comes to compliance—making it an example for other industries.
Both U.S. and European authorities regularly conduct inspections to verify compliance. “Inspection readiness” is therefore an essential requirement. Companies must always be prepared for visits from regulators who want to verify adherence to standards related to quality, safety, and efficiency. Central to this requirement is the accurate recording of research data and results, systematically, completely, and within strict deadlines, in the so-called Trial Master File (TMF). This key file must be fully up to date and accessible at any time to everyone involved in clinical trials. Compliance with TMF procedures and rules is therefore a fundamental requirement for every pharmaceutical company.
This explains why the industry constantly seeks ways to maintain and further improve TMF compliance among employees. This challenge becomes even greater when collaboration across groups and locations is required, as these can differ significantly in workforce composition and clinical practices. Furthermore, scientific integrity and staff commitment must be safeguarded (Goodlett et al., 2020; Robiner, 2005).
The case study described here concerns a global pharmaceutical company with more than 40,000 employees, specializing in oncology, immunology, infectious diseases and vaccines, and cardiovascular diseases. Despite significant investments in structural and procedural improvements to optimize compliance behavior—supported by numerous online tools and training programs—an inspection report revealed that TMF filing quality did not fully meet expectations. Specifically, problems were found regarding timeliness (within 30 days after the end of a study), completeness (all required information), and consistency (accurate and coherent data).
Such TMF compliance issues are not unique to this company; they are a well-known pain point across the industry. Conventional compliance interventions used in the sector are no longer sufficient for two main reasons. First, these interventions typically focus on formal knowledge transfer and standardized procedures, without fostering a self-regulating attitude and behavioral change. While this was acceptable when the goal was to train employees to strictly follow instructions, it is unsuitable for promoting compliance that must coexist with initiative, proactivity, and autonomous decision-making—especially under high complexity and volatility, such as during the COVID-19 crisis. This new way of acting is described in this article as Compliance 2.0 behavior. Second, unlike before, a considerable (and growing) portion of required knowledge is now acquired informally during daily work practices.
To address this deeply rooted compliance challenge, a systematic, transparent, and scientifically grounded approach was required, focusing on improvement. Specifically, this case study employed a design science research methodology, aimed at solving real-world problems by designing and testing practical, context-based solutions. The study can be considered an embedded evaluation case study (Yin, 2009), in which specific parts or processes within a broader context are evaluated through a longitudinal design intervention with a treatment group and a control group. This allowed the effects of the intervention to be isolated, compared, and understood.
The intervention focused on two key elements: self-regulated learning (SRL) and behavioral change. Teaching compliance behavior involves much more than knowledge transfer. The intervention therefore concentrated on three essential SRL elements—goal setting, help-seeking, and emotional control—that play a major role in whether or not compliance behavior is displayed.
In addition, the intervention emphasized observing and evaluating compliance behavior itself. It had become clear that neither structural/process adjustments nor performance indicator monitoring alone could deliver better compliance. For this reason, a number of Key Behavioral Indicators (KBIs) were defined (e.g., planning ahead, calendar management, proactively gathering information, staying up to date with TMF functionality). These KBIs ultimately contribute to accurate and timely TMF filing and thus to the corresponding KPIs (Key Performance Indicators). The intervention was designed not only to train desired behavior but also to identify structural and procedural obstacles in the work environment.
In co-creation with the company’s quality team, the intervention was designed with four perspectives on the learning process:
Activity-based – participants performed practice-oriented learning tasks within their social work environment. This facilitated skill development and deliberate practice in their authentic work context.
Continuous mutual feedback – experience sampling and reflective journaling enabled participants to give and receive feedback. After each task, they reflected on execution quality and selected one or more relevant “tags” (e.g., “I asked for help from a colleague/expert,” “I felt in control of my work,” or “I learned something new about TMF”). The project team reviewed weekly messages and provided feedback and practical suggestions.
Self-regulated learning – the intervention was designed to stimulate SRL through a cyclical process of planning, monitoring, and reflecting. This iterative cycle ensures continuous adaptation and preparation for future tasks.
Team learning – collective learning is essential for broad behavioral change. Since teams can also develop negative norms, participants were encouraged to seek out trusted, experienced colleagues to ensure alignment with organizational mission, vision, and compliance requirements. This accelerated adoption of desired compliance behavior within teams.
The intervention group was selected on a voluntary basis from ongoing clinical trials in Europe, the U.S., and Australia. A control group was used for comparison, completing the same pre- and post-questionnaires but without receiving the intervention. In total, 30 employees actively participated in the intervention, which was conducted over an 8-week period.
To maximize usability, the intervention used the innovative learning application LoopMe. Accessible via smartphones, tablets, or computers, it supported learning, served as an instrument for the Experience Sampling Method (ESM), and facilitated reflective journaling. For participants, it offered an easy way to document learning processes; for the project team, it enabled rapid data collection and analysis.
Behavior was evaluated not only in terms of compliance performance but also in relation to SRL. Literature strongly supports the claim that increased SRL leads to goal-directed organizational behavior (such as TMF compliance) (Sitzmann & Ely, 2011). Using their heuristic framework of 16 SRL constructs, both qualitative self-reports and quantitative LoopMe data were analyzed. Results showed that the intervention stimulated key SRL components, particularly goal-setting, planning, and monitoring. Help-seeking was also frequently reported, while emotional control emerged as an important factor for long-term behavioral change.
Pre- and post-questionnaires confirmed improved SRL in the intervention group, while no learning effect was found in the control group. Participants also reported greater support from internal TMF experts and managers and indicated that old behaviors were more easily replaced by new Compliance 2.0 behaviors.
LoopMe also enabled broader feedback, giving management deeper insight into contextual factors that influence compliance in authentic work settings. Two key findings stood out:
Many management assumptions about compliance behavior did not match reality. For example, changes to TMF functionality were not always communicated clearly, requiring extra effort from employees.
Structural and procedural factors often hindered rather than supported desired compliance. A notable obstacle was the performance measurement system, which assessed compliance primarily at team level rather than individual level. For effective SRL and behavioral change, clear individual performance indicators are essential.
This case study demonstrates that a Compliance 2.0 approach, focused on fostering self-regulated team learning, can stimulate desired employee behavior. Crucially, desired behavior must be clearly defined from the outset so that learning processes can be directed and gradually embedded in organizational structures and processes through systematic employee feedback.
Design Science Research Methodology is not only about understanding organizational problems scientifically but also about solving them. Research must deliver a set of design requirements for problem-solving—not only in the specific case (here, the pharmaceutical sector) but also in other organizations seeking solutions to similar compliance challenges (Dresch et al., 2015).
From the pharma case, we distilled a set of design requirements useful for all resilient organizations when developing a Compliance 2.0 approach (Kaminski & Robu, 2015; Root Martinez, 2019; Katayama, 2020).
Type of Requirement Specification
Functional requirements (state-of-the-art criteria to be included in the approach)
• Define compliance in terms of concrete desirable Compliance 2.0 behaviors (Key Behavioral Indicators). • Focus on self-regulated team learning and deliberate practice with two-way feedback in the authentic work context. • Balance measurement and evaluation of individual and team compliance KPIs. • Incorporate an ESM tool when introducing Compliance 2.0, so that structures and processes can be quickly adapted to facilitate desired behavior.
User requirements (practical conditions for usability and usefulness)
• Domain-specific knowledge is an important enabler of Compliance 2.0 behavior—ensure accessible tools and procedures. • Facilitate team discussions about compliance issues. • Enable quick verification of personal and team performance. • Align training with existing practice and skill levels. • Ensure management commitment.
Constraints (non-negotiable requirements: legal, institutional, ethical standards)
• In the pharmaceutical sector, inspection readiness is a key requirement. • In most sectors, compliance processes must be transparent, with clear communication about data collected, methodologies, results, and actions taken in response to findings.
Design limitations (organization-specific constraints regarding time and resources)
• Developing a Compliance 2.0 approach must not disrupt ongoing work or increase workload for already overburdened staff. • Limitations in staff availability must be taken into account.
Although this case study focused on a global pharmaceutical multinational, the Compliance 2.0 approach is also highly relevant for SMEs—especially growing SMEs. During growth, these companies often introduce additional structures and standardized processes to increase predictability and compliance. However, this strategy can diminish resilience, proactivity, and the entrepreneurial spirit of early employees.
The Compliance 2.0 approach shifts focus from structure and process to behavior. It combines the strengths of proactivity, resilience, and entrepreneurship with the necessary standardization and predictability required during growth. This also implies a more strategic role for Learning & Development, centered on organizational behavioral change. Growing SMEs can thus balance compliance with a dynamic entrepreneurial culture—essential for their future development and success.
Both internal and external compliance requirements force organizations to adopt a new style of working: Compliance 2.0 behavior. Employees must think along, contribute ideas, share insights, and influence compliance-related decision-making. This requires adopting a Compliance 2.0 culture—not as a necessary evil, but as a way of working that fosters pride in both individual contributions and organizational performance (Parker & Gilad, 2011; Van den Berg, 2024). This is where an innovative Compliance 2.0 approach can truly make the difference.
Define compliance in terms of work behavior, so that the compliance process can be directly supported and sustainably embedded in the organization.
Harness employees’ own insights and evaluations of opportunities to comply with internal and external regulations.
Focus on concrete skills, not just theoretical knowledge of rules.
Support Compliance 2.0 with organizational measures such as open discussion of compliance issues and successes, and incorporating compliance performance into appraisal systems.
Management is often unaware of the time and effort employees must dedicate to compliance.
Denyer, D., Tranfield, D., & Van Aken, J.E. (2008). Developing Design Propositions through Research Synthesis. Organization Studies, 29(3), 393–413.
Dresch, A., Lacerda, D.P., & Antunes Jr, J.A.V. (2015). Design Science Research. Springer.
Gautam, S.R., & Bhavsar, D. (2022). A Post Covid-19 Outlook: The Future of Pharma Operations. International Journal of Research Publication and Reviews, 3(3), 145–149.
Goodlett, D., Hung, A., Feriozzi, A., Lu, H., Bekelman, J., & Mullins, C. (2020). Site Engagement for Multi-Site Clinical Trials. Contemporary Clinical Trials Communications, 19, 100608.
Kaminski, P., & Robu, K. (2015). Compliance 2.0: Emerging Best Practice Model. McKinsey.
Katayama, H. (2020). Beyond Compliance: Creating a Culture of Integrity. Kroll.
Parker, C., & Gilad, S. (2011). Internal Corporate Compliance Management Systems: Structure, Culture and Agency. In C. Parker & V.L. Nielsen (Eds.), Explaining Compliance: Business Responses to Regulation (pp. 170–195). Edward Elgar.
Robiner, W.N. (2005). Enhancing Adherence in Clinical Research. Contemporary Clinical Trials, 26, 59–77.
Root Martinez, V. (2019). The Compliance Process. Notre Dame Law School, 94 Ind. L.J. 203.
Sitzmann, T., & Ely, K. (2011). A Meta-Analysis of Self-Regulated Learning in Work-Related Training and Educational Attainment. Psychological Bulletin, 137(3), 421–442.
Van den Berg, B. (2024). Wat is compliance? En waarom moet elke mkb-ondernemer ermee aan de slag. De Zaak.
Yin, R. K. (2009). Case Study Research and Applications: Design and Methods (4th ed.). Sage.
In today’s rapidly changing society, higher education institutions face significant challenges. Graduates increasingly encounter jobs and roles that demand advanced competences such as creativity, entrepreneurship, and problem-solving—skills needed to compensate for the limited shelf life of acquired knowledge (World Economic Forum, 2016; Levy & Murnane, 2013). At the same time, funding stakeholders demand greater transparency and legal accountability, while students increasingly act as demanding customers.
Higher education organizations respond by expanding and professionalizing their management structures, often with a strong emphasis on planning and control. To meet stakeholder demands, they tend to meticulously quantify and monitor educational outcomes. Frequently, this does not stop there: more and more institutions attempt to standardize the educational process by introducing evidence-based procedures, protocols, and imposed formal curricula.
This “management evolution” is met with resistance on the work floor. Faculty members stress the importance of professional autonomy and self-determination in the teaching process as key conditions for delivering quality education. The question of how to lead professionals therefore remains pressing. Or is it, in fact, a futile effort—and should leadership of professionals be avoided altogether? We offer five recommendations for effective leadership.
1. Focus on Intrinsic Motivation
Eighty percent of professionals prefer to do their work well rather than poorly, driven by their love for the profession (Weggeman, 2007). Ample research in education confirms that teachers play a crucial role in stimulating student learning (Creemers & Kyriakides, 2008; McCaffrey et al., 2004; Heck & Hallinger, 2014). In a three-year longitudinal study across sixty schools and 2,894 students, Heck & Hallinger (2014) confirmed that “teacher effects matter when modeling growth in student achievement.” The message is clear: to create added value as professionals, knowledge, skills, and attitude are all essential.
Leaders and administrators should therefore define clearly what characterizes education professionals who generate added value: employees who are both skilled in their domain and demonstrate a professional attitude. In higher education, subject expertise has two dimensions: mastery of the specific academic domain and pedagogical-didactic competence.
A professional attitude means that love for the profession outweighs love for money or leisure (Weggeman, 2007). Passion for the discipline is central to choosing and maintaining professional behavior. Material gain is rarely the only motivation for professionals; intrinsic motivation should be prioritized. Deci & Ryan (2000) regard intrinsic motivation as a psychological growth function to realize autonomy, competence, and relatedness—universal human needs. Meeting these needs enhances subjective well-being. Motivation is therefore not merely about “quantity,” but above all about “quality.” Leadership can facilitate or hinder this intrinsic motivation.
Leaders should therefore select and guide true education professionals and place the facilitation of intrinsic motivation high on their agenda.
2. Facilitate the Growth Trajectory
Education professionals have a deep need to develop their talents and push the boundaries of their capabilities. They evolve from novices to experts by combining rational and experiential learning. Yet the half-life of domain knowledge is rapidly decreasing. Leaders must therefore create learning environments that allow faculty to continuously develop as experts. Professional status must be earned and maintained. If faculty members neglect this responsibility, it may be necessary to temporarily withdraw certain rights or responsibilities. Huisman & De Vijlder (2012) rightly advocate strengthening professional governance, emphasizing the “self-cleaning capacity” of the profession itself. Leaders should also monitor faculty who neglect professional development—this signals the need for a conversation.
In short: leadership should facilitate and monitor the growth trajectory of education professionals.
3. Foster Team Flow
Faculty increasingly work in teams across programs and curricula. Over time, multiple teachers shape the learning journey of students. Heck & Hallinger (2014) found that a sequence of effective teachers has an even greater impact on student achievement growth.
Faculty must therefore also be able to collaborate effectively, enhancing collective outcomes. Van den Hout (2016) defines team flow as “a shared experience of flow during the execution of interdependent personal tasks in the interest of the team, originating from an optimized team dynamic and typified by seven prerequisites and four characteristics.” Team flow not only increases team effectiveness but also enhances professional well-being.
Team flow depends on group dynamics grounded in several conditions. Its foundation is a collective ambition: a shared understanding of the team’s purpose. Derived, concrete goals align with individual objectives. Team members complement one another to achieve complex outcomes. They are also “loyally oppositional,” intervening when excellence is at risk. Feedback and self-regulation enable the team to monitor its performance. Teams may distribute leadership roles informally and operate largely self-managing, or designate a formal leader to synchronize problem-solving and integrate contributions.
Leaders act as the protective shield for these teams, filtering out external disruptions such as procedures or regulations that could undermine team flow. Beyond that, they should let team dynamics unfold, including the authority to decide on membership.
4. Structure the Organization
Higher education must facilitate complex learning. Teaching cannot be reduced to direct instruction alone; it requires a holistic approach where students actively participate in the learning process to maximize transfer and meta-learning. Van Merriënboer & Kirschner (2007) developed a framework for effectively facilitating complex learning, centered on authentic tasks. Curricula should be designed along learning-outcome trajectories of gradually increasing complexity and support (Baert et al., 2016). Within these trajectories, courses are designed and teams of education professionals aligned.
Leaders should therefore structure the organization in a way that maximally enables team flow.
5. Create Instructionally Focused Leadership
In many education organizations, HR specialization has advanced: managers without pedagogical expertise often oversee personnel policy. While this professionalization brings focus, it also risks fragmentation. Increasingly, leaders are appointed who lack subject or pedagogical background. This creates coordination challenges, as Mintzberg (1979) already warned: dividing tasks that later require tight coordination can generate friction. In many institutions, HR and education have become separate silos, making integration difficult. Heck & Hallinger (2014) showed that instructionally focused leadership indirectly influences student achievement by strengthening the pedagogical-didactic environment. Such leadership combines instructional and transformational elements. Across the organization, leaders are needed who are competent in both pedagogy and HR.
In short, leading professionals can generate significant added value—indirectly—but it requires doing the few right things, truly well.
Bart Derre
Director, Center for Entrepreneurship, University College Ghent, and PhD candidate, Department of Industrial Engineering & Innovation Sciences, Eindhoven University of Technology (TU/e)
Mathieu Weggeman
Professor of Organization Science, specializing in Innovation Management, Department of Industrial Engineering & Innovation Sciences, Eindhoven University of Technology (TU/e)
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