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Case Studies

Food Co-op Engages Its Members

“There was no way to move forward until we could build consensus around a plan for the future of this organization,” said Paul Cultrera, general manager.

“Things were so bad,” said then board of directors member Peter Keat, “that we literally felt paralyzed as an organization.”

With tensions running high, Cultrera interviewed Eric Douglas of Leading Resources Inc. (LRI). Cultrera was impressed by Douglas’ track record for managing change and gaining consensus within large organizations. “I was looking for someone with really good communication skills,” Cultrera said. “Someone skilled at working with diverse constituencies.”

D2K: Establishing Trust as a Foundation for Long-term Growth

Together Douglas and Cultrera mapped out a five-stage process they called “Directions 2000” or “D2K.” The process was carefully crafted to engage as many member-owners as possible in a productive dialogue with management and each other. At each stage of the process, Douglas guided the participants toward an understanding of the complex business issues under consideration while improving their communication and problem-solving skills. Because the issues were complex, and emotions were running high around the issue of expansion, flexibility had to be at the heart of the process itself.

“Eric has experience working with large, fractured groups, so he was able to bring people together in a constructive manner,” Cultrera said. “As we got into the process and realized that changes needed to be made, he was flexible. He didn’t have a tremendous amount of ego tied up in his own process.”

Stage 1: Identifying Basic Values

“I sat through all 13 of these ‘listening’ sessions and hardly said a word,” Cultrera said. “Eric facilitated them tightly, to the extent that there was a program – but loosely, to the extent that people were able to express themselves very freely. It took me out of it, so there wasn’t this perception of the general manager pushing this thing where he wants it to go.”

Stage 2: Casting a Wider Net

Using input from the focus groups, LRI drafted a survey with 50 questions about values and visions and distributed it to all 7,000 Co-op member-owners. LRI’s analysis of the 1,645 returned surveys confirmed that pricing was most important to members. Member-owners were evenly divided on the question of whether to expand to additional locations. A third issue that came into focus from the survey was the 5% member-owner discount: Owners did not want to give it up, even if it meant they paid higher prices in the store.

Stage 3: Moving Beyond Conflict to Strategy

With the survey data in hand, a group of 25 people – comprised of 15 member-owners, seven members of the Board of Directors and three members of management – began working together as the D2K Planning Team under the guidance of LRI consultants.

Within a few weeks, the team had defined the purpose and values – what Douglas calls the “strategic foundation.” The team then faced the question of vision – and the deep conflict over whether or not the Co-op should expand to a second store.

As a first step, Douglas broke the drafting committee into two teams to generate deeper discussion. The resulting dialogue between the teams ultimately led to a draft vision that called for the Co-op to extend its services “to as many people as possible in the communities we serve.”

“This vision was based on a philosophy of inclusion,” said Keat who was a Planning Team member. “The Co-op offers something very special in the quality of its products, its support for local farmers, and its reliance on cooperative economic principles. Our vision was to share that.”

“We tested this vision again and again within the Planning Team,” Douglas said. As they grew more comfortable, team members used a combination of brainstorming exercises, management input and survey feedback to develop seven key goals to achieve the vision. LRI consultants carefully translated their decisions into a draft strategic plan.

Stage 4: Honoring the Process through Feedback

The resulting feedback was overwhelmingly positive. More than 95% of those responding said they supported the process. More than 90% said they supported the vision.

“Based on our previous experience, I thought we might get 55% in favor and 45% opposed. And then we’d be stuck where we were at the beginning,” Cultrera admitted.”Instead, we got a very high approval rating of each individual piece of the plan.”

Even more surprising: “Many of the member-owners who approved the plan had only been touched tangentially by the process – through taking the survey or reading about it in the Co-op’s newsletter,” Douglas said. “But because they had been touched, they supported the change.”

Stage 5: From Approval to Action

After unanimously voting to approve the plan, the Board handed it over to management to implement. “It makes my job as general manager a whole lot easier,” Cultrera said.

“Now, when we run into pockets of controversy or resistance, it’s very easy to say, ‘Well, thank you. I really appreciate your input. But we heard from a lot of people who said this is what they want us to do.’ I feel like when there are other issues we need to face on a nitty-gritty level, we can call that process up again.”

Roadmap to the Future: From Plan to Action

That opportunity was right around the corner. Fresh from the D2K victory, the Co-op again hired LRI to implement one of the plan’s key initiatives. This was the hot button issue of deciding whether to keep or modify the 5% member-owner discount.

True to the D2K process model, Douglas and Cultrera ensured a high level of member-owner involvement at every stage.

They convened a half-dozen “focus groups” to educate member-owners about the impacts of the discount. As with D2K, a Planning Team representing a broad spectrum of viewpoints was selected by LRI to explore alternatives and make a recommendation to the Board.

“At that point, we ran up against the fact that grocery store finance is not easy,” said Douglas. “Yet the team had to learn it in order to make a cogent decision.” For example, the Co-op marked up prices for most items beyond the normal operating markup to support the 5% member-owner discount. This meant higher prices throughout the store and placed the Co-op at a competitive disadvantage with other natural food store chains in the market.

“There were lots of questions and concerns,” said Barbara Mendenhall, Board president. “Eric finally broke us into small groups and asked us to answer three questions:

‘Is there a problem that needs to be fixed?’ ‘What would you propose as an alternative to the discount?’ and ‘What additional information do you need?’

All of the groups came back and said yes, there is a problem. It needs to be fixed. And here’s what we think the new benefits package should be. The amazing thing was – we all proposed the exact same solution!”

As team members became convinced of the wisdom of changing to the discount structure, some wanted to survey member-owners about the alternatives they were considering. “But a new survey would only confirm what the earlier survey told us,” Douglas said. “Without going through the education process, people would resist giving up the discount.” The team finally agreed to stage a series of forums that would bring member-owners from the Planning Team face to face with fellow member-owners still skeptical about making a change.

It was a critical part of the process that Mendenhall calls “transformative.”

“One planning team member really turned the group around just on the force of her own presentation,” Mendenhall said. “As she talked about what she and the group had gone through, you’d start to see heads nod. You could see she felt it from the heart.”

With positive feedback from member-owners, the Board approved changes to an end-of-the-year patronage refund that has worked well at a number of co-ops throughout the country, combined with special pricing programs such as monthly category specials. Some of the original benefits – such as a 10% discount on Owner Appreciation Days – remained in force.

Moving Ahead with Confidence

“We’ve learned that there are a variety of ways to involve members in decision-making, besides just sending everything out for a member vote,” said Mendenhall. “Communication and cooperative education are very important.”

Cultrera agrees. “Because we kept the lines of communication open with the ownership throughout this long process, we heard from people we had never heard from before. By the end of it, member-owners clearly honored the process, so they trusted the plan. It’s given the organization a tremendous amount of strength and ability to keep moving forward.”

The bottom line:

The Co-op’s annual sales increased to $17 million. Its employees had received an across-the-board pay increase reflecting the plan’s commitment to a quality workplace. Meanwhile, the Co-op had begun looking at new locations for a second store, this time with the clear support of its owners.

We hope you enjoyed this organizational development case study. To schedule an initial meeting with LRI, please contact us online or call 1-800-598-7662.

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Cases and Exercises in Organization Development & Change

Donald L. Anderson - University of Denver, USA

"Has a number of timely case studies, including ones on non-profit and educational institutions."

An excellent book with lots of applied problems/case studies.

Good cases and excellent overall structure of the book. however, I was also looking for mini-cases

A well written book that has a number of useful cases and activities that will help to link theory to practice for change management and organisational development.

A mix of great, some useful exercises and cases though some seem to be a bit basic and perhaps out of date

Donald L. Anderson

Donald L. Anderson , Ph.D., University of Colorado, teaches organization development at the University of Denver and organization design at the University of Colorado, Boulder. He is a practicing organization development consultant and has consulted internally and externally with a wide variety of organizations, including Fortune 500 corporations, small businesses, nonprofit organizations, and educational institutions. Dr. Anderson’s research interest is in discourse in organizational and institutional settings, and his studies of organizational discourse and change have been published in journals such as the Journal of Organizational Change Management, Gestion , and Journal of Business and Technical Communication . He is the author of the text Organization Design: Creating Strategic and Agile Organizations (SAGE, 2019) and editor of the text Cases and Exercises in Organization Development & Change (2nd ed., SAGE, 2017).

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Case writing is a vital force behind research at HBS. Nearly 80 percent of cases used at business schools worldwide are developed by HBS faculty. HBS case studies have helped refine the skills and business judgment of tens of thousands of students, practitioners, and academics across the world. The School is continually expanding and refreshing course content as HBS faculty write new cases that span the globe, industries, disciplines, and organizational forms in the public, private for profit, and non-profit spaces. As its faculty continues to develop case studies, the School is shaping business learning and educating future leaders in a positive way for years to come.

What is a case study?

The HBS case study is a teaching vehicle that presents students with a critical management issue and serves as a springboard to lively classroom debate in which participants present and defend their analysis and prescriptions. The average case is 15 to 20 pages long (about 7 to 12 pages of prose and 5 to 7 pages of tables and figures). The two main types of cases at the School are field cases based on onsite research, and library cases written solely from public sources. HBS also writes "armchair" cases based entirely on faculty’s general knowledge and experience. Moreover, in 1995, the School’s Educational Technology Services began producing multimedia cases that provide a rich learning experience by bringing together video, audio, graphics, animation, and other mediums.

Case research and writing

At HBS, academic research and case development are connected and mutually reinforcing. Cases provide the opportunity for faculty to assess and develop ideas, spark insights on nascent research questions early in a project, illustrate theory in practice, and get feedback in the classroom on those very concepts. In addition, case writing provides faculty a means to collaborate and to develop research ideas both across disciplines and across institutions.

Field case development is a dynamic and collaborative process in which faculty engage business or governmental leaders, sometimes working together with a colleague at HBS or at other academic institutions. The Case Studies for Harvard Business School brochure is a helpful resource to organizations interested in working with the School on a case. Case leads are identified based on a faculty’s teaching purpose and may arise as the result of a past relationship with an executive, a former student, or from a professor’s interest in exploring with a company’s management team a situation that would provide a meaningful learning experience. HBS works closely with host organizations to guarantee confidentiality.

Field cases typically take two months to complete - from obtaining a host organization’s approval to move forward on a case, to conducting onsite interviews, and drafting a case that paints a picture of the management issue and provides a mix of real-world uncertainty and information required for decision-making analysis.

Case support

A vast array of case-writing support is available to HBS faculty. Support is provided by case writers who work as individual research associates or are available on a project by project basis through our on-campus Case Research and Writing Group and eight regional research centers ( Asia-Pacific , California , Europe , India , Japan , Latin America , Harvard Center Shanghai , and Istanbul). Baker Library’s extensive business collection and specialist librarians comprise another invaluable research and case-writing resource.

Participating in a Case Study

Organizational Development Case Study

Organization development case study: introduction.

For any organization to be successful in its field and progress to profitability, it is important that managers and employees in its leadership embrace organizational development. According to Cummings and Worley, “Organizational Development (OD) is a planned long-term effort led and supported through the top management to improve an organization’s ability in a bid to solve its own problems by continuously working together and managing the culture using behavioral skills” (2005, p. 1).

The paper uses the Tedtec Company Limited, which is a fictional organization. The company chosen for this case study is respected in the country of origin. It is among the pioneers of organizational development in the country. Tedtec Company Limited that is located in India has been in operation for the last 70 years dealing with machinery, engineering, production, and construction works.

According to the results of the performance index of India’s companies, Tedtec Company Limited “is also adjudged India’s best managed and most respected company on various attributes of customer delight and shareholder value” (Roy, 2006, p. 25). The case study on organizational development was based on this company because of its significant history in this field in India.

Company profile

Tedtec Company Limited is among the most respected of India’s private sector companies that deal with technology, construction, engineering, and manufacturing. The company has been in existence for about seven decades with a strong international presence including offices in the China as well as her Gulf neighbors.

A wide marketing and distribution network and decades of strong customer focused approach has ensured that the company is the leader in its field. The company also “believes that progress must be achieved in harmony with environment” (Roy, 2006, p. 25). This claim has informed its commitment to protection of the environment and participation in community welfare.

Some of the achievements that the company has made include the record for having made the largest coal gasifier in India that it exports to China.

It is the largest FCC regenerator for a refinery, which is the longest coal conveyer in the world besides being Asia’s highest viaduct and the world’s largest EO reactor for a protochemical complex in the Gulf. The company also took part in the construction of India’s first nuclear powered submarine. It has won a number of local and international awards and recognitions.

The company is also one of the most profitable construction companies in the region with thousands of employees being employed directly or indirectly by the company. A policy of giving back to the society has ensured that the company establishes good relations with workers and the communities in which it is involved, with only the issue of pollution being the major challenge.

Tedtec Company Limited has however managed to remain viable and important within the manufacturing and construction sector even with the financial crisis experienced over the years in this part of the world and elsewhere in the world.

Diagnostic methods

The methods used for diagnosis in this particular organization included interviews and questionnaires, which were addressed to the employees in the organization. Initially, the company had experienced faults in its existing appraisal system at some point in its history. This challenge necessitated a professional correction of the system.

The company elicited help from some of experts in this field with eminent professors being invited to carry out a study and assessment of the appraisal process in the company (Wilson, 2003, p. 13). Walter Jay and Engineer Schwartz Raymond were the professors that were consulted in the evaluation process for the company.

In their study of the appraisal process in the company, they began by interviewing departmental heads and their subordinates. To accomplish the interview, they used diagnosis or action research with the results being recorded and analyzed against a background of other results they had gotten elsewhere and against the existing case studies.

Analysis and feedback methods

From the diagnostic methods used in the company, a number of feedbacks were obtained. In the analysis of information provided by the subordinates in the various departments, there was apparent communication breakdown in the administrative hierarchy with junior workers not getting information and feedback on their performance in the company.

This case was despite their expressed a desire to get the feedback, which was not forthcoming. Another interpretation of the results of the feedback included the fact that the managerial staff members were responsible for a large number of employees thus making an appraisal of their subordinates difficult.

However, one shortcoming was that the appraisal form used was too lengthy meaning that the number of employees participating was reduced due to time constraint.

The results of the feedback were presented by the two professors to the top management of the company for consideration and formulation of suggestions and recommendations on the possible solutions to the actual problem.

According to Cummings and Worley, an appraisal system is important in any organization as it helps the company’s employees to understand their strengths and weaknesses and the progress they are making in the job performance (2005, p. 15).

It also enables them to understand the options available for growth in the company. Cummings and Worley claim that the process should “address the issues of appraisal, potential, counseling, career development, and training all in one” (2005, p. 15).

SWOT analysis

As in the case of IKEA that was discussed as a case study, Tedtec Company Limited used SWOT analysis in the achievement of objectives and planning of its strategic achievements.

As discussed in the essay and in the literature on planning strategies in organizations, this form of analysis investigates the Strengths, Weaknesses, Opportunities, and Threats that an organization establishes in its course of operations and development (Cummings, & Worley, 2005, p. 15).

According to Cummings and Worley, threats are external to an organization, and are outside the control of the company with the best examples being economic performance of the country, the levels of technology at the time, social changes, and the environmental conditions (2005, p. 24).

On the other hand, strengths and weaknesses are internal to an organization thus serving to counter the threats that are outside the organization’s control (Cummings, & Worley, 2005, p. 25).

As an opportunity, Tedtec Company Limited has over the years invested in manufacturing and construction industry. It boasts of creating a respected brand in India. The company has been in existence since 1938 when it started as a manufacturer of daily equipment.

Therefore, it has a well-established organizational culture and management policies that stand the test of time. The company also has vast investments in technology, investing heavily in the latest technology available in the industry. This opportunity has created a competitive edge over her competitors.

As strength, the organizational culture in the organization has been described as a goal-oriented one with the employees largely reporting career satisfaction when working with the company.

The company has invested in a number of international brands mainly in the region thus ensuring relevance and competitiveness in the industry. With diversification of its operations, the organization is now able to produce different products besides offering a range of services in the region.

A significant weakness that the organization has established in its operations is the pollution that has been created in the production method in the process of rectification following the ambitious investment in environmental conservation and social responsibility.

The company also faces a threat in operations in the form of the financial crisis that, as demonstrated in the last one, has the ability to paralyze its operations. The threat is however countered by the cautious financial investment in other market coupled with strict financial auditing and consultations.

OD intervention options and general risk and value scenarios

The assessment of risks in an organization is important as it enables the management to formulate the desired change and effect on it. This assessment is quite crucial for any company since it makes it aware and ready for any particular risk that it might incur.

Many companies have experienced an untimely closure following the occurrence of risks that it did not expect or rather risks that were not planned for in the event of their occurrence.

For Tedtec Company Limited, the specific interventions that were necessary included diversification of products and expansion into other markets to counter the decline in demand in the home country in a bid to create new opportunities to secure industrial relevance.

In the analysis of vales, one of the relevant values to the company is customer service. The company has established a number of methods of ensuring the customers are loyal to it. Customer loyalty is recognized as one of the factors leading to the success of many organizations and that the company is no exception (Cummings, & Worley, 2005, p. 25).

To guarantee exceptional customer service, organizations need to have an effective indicator in place (Cummings, & Worley, 2005, p. 21). For Tedtec Company Limited, customer loyalty rating is the key indicator. The organization has commissioned a number of surveys to find out the satisfaction of its clients on its products and services.

According to Cummings and Worley, this strategy is an effective way of doing it (2005, p. 21). The results have then been used to gauge performance and or inform decision-making.

The expected benefits include improved service provision and customer satisfaction as well as profitability. The company also utilizes feedback from clients especially complaints that are provided as feedback to change its operations.

Since Tedtec Company Limited carries out many civil projects that are funded by the Indian government and other governments, the quality of work is also evaluated by government contractors as well as other state agencies concerned with quality control (Cummings, & Worley, 2005, p. 25).

This ensures a subjective review of products and services provided thus ensuring that there is quality in the future projects. The strategy has enabled the company to win a number of tenders based on previous projects that were evaluated as being professionally carried out.

Evaluation methods

According to Cummings and Worley, post change evaluation in an organization is important since it presents the executives with a picture of the effects of the change (2005, p. 17) made by the change agent “in consultation with the management of the organization” (Wilson, 2003, p. 23). Wilson also states, “The evaluation sets initial agreed aims and objectives against the current, post-change situation” (2003, p. 23).

In the analysis made of Tedtec Company Limited, the attitude and satisfaction of workers as well as the financial outlook and performance ratings were made thus being some of the most common areas of evaluations in an organization development analysis.

The results of the evaluation were then presented to the management. The summary consisted of areas where the effected change was successful, recommendation for improvement, areas that were unsuccessful and not in line with the company objectives, areas that required constant monitoring, and the suggested rolling evaluation program.

For Tedtec Company Limited, the results showed success in areas of change such as improved organizational performance since the entry of the firm in to the international market.

The change in organizational culture, which was made mainly involving the diversification of the employee base, was also reported to influence the company in a positive manner with the employees reporting improved satisfaction from the working conditions.

The employees also reported a breakdown in communication and ineffective management mainly due to the large size of the personnel department, which was created by expansion. This exposition meant that the employees were getting inadequate attention from their bosses.

Recommendations

One of the recommendations is that the company should consider splitting or bifurcation of the personnel department in the company to ensure that fewer employees are under the supervision of managers in the various departments. It is said that the smaller the number of subordinates that each manager is responsible for, the better the output of the employees (Wilson, 2003, p. 21).

The company should also consider increasing the number of managerial staff especially those in the human resource department in an attempt to improve the contact between the administration and subordinates (Wilson, 2003, p. 18). Another recommendation is that the organization should monitor the human resource department and the marketing department to enhance customer loyalty.

OD Case Study: Conclusion

In conclusion, organizational development is an important aspect in the success of companies. Organizations that wish to perform well have a well established organizational development plan that stipulates the issues that they need to do or rather the issues that they need to be aware of so that they remain not only in track but also ready for any unexpected emergency.

The paper has used the Tedtec Company Limited as a fictional company in an attempt to address this key issue of organizational development. Thus, its evaluation should be carried out in a formal manner. Tedtec Company Limited is considered to have made significant organizational changes since its inception. The changes have affected its operations in a number of ways.

An evaluation of its organizational development established a number of threats, weaknesses, and strengths, as well as the effects of the organizational change. These elements were then evaluated with recommendations and suggestions being made to the development specialists and business executives of the organization.

Reference List

Cummings, T., & Worley, G. (2005). Organization development and change . Mason, Ohio: Thomson/South-Western.

Roy, S. (2006-2005). Made in India: a study of emerging competitiveness . New Delhi: Tata McGraw-Hill Pub. Co.

Wilson, D. (2003). Promoting institutional & organizational development . London: Dept. for International Development.

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IvyPanda. (2023, October 29). Organizational Development Case Study. https://ivypanda.com/essays/organizational-development-case-study/

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3 August 2023

Benefits of Case Study Learning Approach for Organizational Development

D arden is known for its interactive case method approach to learning. But, what is case method and how is it relevant to organizations in trying to develop their leaders? Lisa Cannell (MBA ’17), Managing Director for Client Solutions , shares her perspective as a former HR leader and Darden MBA grad who now works with corporate and association clients who partner with Darden on leadership development.

In my time as an HR leader, I have helped facilitate many change initiatives and organizational development interventions . Additionally, I have been responsible for developing individual leaders and bringing together top-performing teams. One thing I’ve discovered is the power of stories, where coworkers share examples and experiences to help learn. Most leaders do not have enough examples in their own experience on which to draw – and need to have exposure to peers and other avenues to learn from others’ mistakes and successes. Darden’s case method approach uses case studies to provide those stories, and prompt participants in the room to share their own stories and raise curiosity about options and outcomes. Typically, there is no “right” answer.

HR also has the visibility to see all roles and capabilities needed in the organization and how they inter-relate to meet the goals (or not!). Darden’s MBA program helped me realize even more how this is a unique view that not all leaders have. One of the biggest opportunities in succession planning is to help functional leaders to “ put on the enterprise hat”. This is because they may not have had the opportunity to see or work cross-functionally in their career and are naturally first and foremost concerned about the goals of their function. Oftentimes, I have played the “chief communicator,” for example, to help the operations team understand why the finance team needs “x,” why the sales and marketing team said “y” and why the executive team demands “z.” Case study discussions bring that to life in a safe & experiential environment in the classroom laboratory.

There is mounting research about the importance of critical thinking skills for jobs in the future. For years I have seen this play out – where you really see it is lacking during times such as major corporate decision points, key people issues, unplanned crisis, etc. I have experimented with how to assess this and help leaders to develop critical thinking skills, since it comes with practice. Darden teaches decision-making skills and decision-bias, both of which directly help critical thinking; however, all case study discussion, regardless of the case topic, is practice in critical thinking. Participants are put in a situation where they must think on their feet, ask questions and share their recommendations. Case study discussions build the critical thinking muscle.

Benefits of Case Study Discussion

Multiple aspects of business intertwined – demonstrates enterprise perspective.
Non-intrusive way to open up discussion on sensitive issues – focus is on another organization and what they did, should do, etc.; however, the mirror is held up eventually, usually by a participant saying “this is like us.”
Broader exposure to examples outside of company and/or industry – helps innovative and creative thinking.
Focused time and opportunity to share stories or real-life experiences where managers have learned lessons with their peers.
Cross-functional contribution to discussion from people across the organization – those who may be expert can help others and observe how their function is perceived.
OD intervention – the spotlight sometimes reveals an organizational issue that inspires participants to open up and have productive dialogue about what they are observing in their own organization and how they can collaborate on new ideas for how to approach issues or address a needed change.
No right answer – no prescriptive training on what to do – only options and decision-making based on critical thinking – reflects real life where there is usually more than one answer.
Safe environment for dissent, open and robust dialogue, and experimentation – much needed in many organizations.
Fun environment where curiosity, laughter and learning go hand-in-hand.
Team engagement to question assumptions, explore alternative viewpoints, and challenge existing processes.
Celebration of the “why” and the “what if” questions that spark innovation and drive positive change.
Critical thinking as a superpower, enabling us to analyze information objectively, identify biases, and challenge the status quo. It’s the art of asking thought-provoking questions – Why did that decision backfire? What assumptions were made? How could the outcome have been different? – and embracing a mindset of curiosity.

I welcome the opportunity to host you and your organization to observe a class and participate in a case study discussion. It is something that you need to experience to really appreciate!

Connect with Lisa to discuss your organization’s development needs or learn more about our Solutions for Organizations .

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1 Creating a Seamless Organization: A Case Study on Organization Development

Published: August 2022
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The case study is a typical representative of majority of the family managed large groups of industries engaged in manufacturing marketing and trading activity through several of their group companies. The case represents major issues faced by the generational and successional chiefs as heirs to the traditional businesses of group companies in their major tasks of further steering of the group companies through the turn around and transformational changes compelled by the major disruptions due to technology, trade restrictions in international businesses, and compliance to several regulatory norms towards climate change and pollution control along with sustainability standards. It is a real churn that these new generational chiefs have to manage to sustain and grow their businesses.

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Methodology

What Is a Case Study? | Definition, Examples & Methods

What Is a Case Study? | Definition, Examples & Methods

Published on May 8, 2019 by Shona McCombes . Revised on November 20, 2023.

A case study is a detailed study of a specific subject, such as a person, group, place, event, organization, or phenomenon. Case studies are commonly used in social, educational, clinical, and business research.

A case study research design usually involves qualitative methods , but quantitative methods are sometimes also used. Case studies are good for describing , comparing, evaluating and understanding different aspects of a research problem .

When to do a case study, step 1: select a case, step 2: build a theoretical framework, step 3: collect your data, step 4: describe and analyze the case, other interesting articles.

A case study is an appropriate research design when you want to gain concrete, contextual, in-depth knowledge about a specific real-world subject. It allows you to explore the key characteristics, meanings, and implications of the case.

Case studies are often a good choice in a thesis or dissertation . They keep your project focused and manageable when you don’t have the time or resources to do large-scale research.

You might use just one complex case study where you explore a single subject in depth, or conduct multiple case studies to compare and illuminate different aspects of your research problem.

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Once you have developed your problem statement and research questions , you should be ready to choose the specific case that you want to focus on. A good case study should have the potential to:

Provide new or unexpected insights into the subject
Challenge or complicate existing assumptions and theories
Propose practical courses of action to resolve a problem
Open up new directions for future research

TipIf your research is more practical in nature and aims to simultaneously investigate an issue as you solve it, consider conducting action research instead.

Unlike quantitative or experimental research , a strong case study does not require a random or representative sample. In fact, case studies often deliberately focus on unusual, neglected, or outlying cases which may shed new light on the research problem.

Example of an outlying case studyIn the 1960s the town of Roseto, Pennsylvania was discovered to have extremely low rates of heart disease compared to the US average. It became an important case study for understanding previously neglected causes of heart disease.

However, you can also choose a more common or representative case to exemplify a particular category, experience or phenomenon.

Example of a representative case studyIn the 1920s, two sociologists used Muncie, Indiana as a case study of a typical American city that supposedly exemplified the changing culture of the US at the time.

While case studies focus more on concrete details than general theories, they should usually have some connection with theory in the field. This way the case study is not just an isolated description, but is integrated into existing knowledge about the topic. It might aim to:

Exemplify a theory by showing how it explains the case under investigation
Expand on a theory by uncovering new concepts and ideas that need to be incorporated
Challenge a theory by exploring an outlier case that doesn’t fit with established assumptions

To ensure that your analysis of the case has a solid academic grounding, you should conduct a literature review of sources related to the topic and develop a theoretical framework . This means identifying key concepts and theories to guide your analysis and interpretation.

There are many different research methods you can use to collect data on your subject. Case studies tend to focus on qualitative data using methods such as interviews , observations , and analysis of primary and secondary sources (e.g., newspaper articles, photographs, official records). Sometimes a case study will also collect quantitative data.

Example of a mixed methods case studyFor a case study of a wind farm development in a rural area, you could collect quantitative data on employment rates and business revenue, collect qualitative data on local people’s perceptions and experiences, and analyze local and national media coverage of the development.

The aim is to gain as thorough an understanding as possible of the case and its context.

In writing up the case study, you need to bring together all the relevant aspects to give as complete a picture as possible of the subject.

How you report your findings depends on the type of research you are doing. Some case studies are structured like a standard scientific paper or thesis , with separate sections or chapters for the methods , results and discussion .

Others are written in a more narrative style, aiming to explore the case from various angles and analyze its meanings and implications (for example, by using textual analysis or discourse analysis ).

In all cases, though, make sure to give contextual details about the case, connect it back to the literature and theory, and discuss how it fits into wider patterns or debates.

If you want to know more about statistics , methodology , or research bias , make sure to check out some of our other articles with explanations and examples.

Normal distribution
Degrees of freedom
Null hypothesis
Discourse analysis
Control groups
Mixed methods research
Non-probability sampling
Quantitative research
Ecological validity

Research bias

Rosenthal effect
Implicit bias
Cognitive bias
Selection bias
Negativity bias
Status quo bias

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McCombes, S. (2023, November 20). What Is a Case Study? | Definition, Examples & Methods. Scribbr. Retrieved April 4, 2024, from https://www.scribbr.com/methodology/case-study/

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Cases and Exercises in Organiz...

Cases and Exercises in Organization Development and Change.

Designed for courses in organization development and change, this is a comprehensive collection of case studies and exercises. Original cases are written by experts in the field and designed to focus very precisely on a specific topic in the OD process or intervention method. Each case is accompanie...

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Published: 05 April 2024

The clinical trial activation process: a case study of an Italian public hospital

Carolina Pelazza ORCID: orcid.org/0000-0002-7875-3710 1 ,
Marta Betti 1 ,
Francesca Marengo 1 ,
Annalisa Roveta 2 &
Antonio Maconi 1

Trials volume 25 , Article number: 240 ( 2024 ) Cite this article

Metrics details

Background/aims

In order to make the centers more attractive to trial sponsors, in recent years, some research institutions around the world have pursued projects to reorganize the pathway of trial activation, developing new organizational models to improve the activation process and reduce its times.

This study aims at analyzing and reorganizing the start-up phase of trials conducted at the Research and Innovation Department (DAIRI) of the Public Hospital of Alessandria (Italy).

A project was carried out to reorganize the trial authorization process at DAIRI by involving the three facilities responsible for this pathway: clinical trial center (CTC), ethics committee secretariat (ESC), and administrative coordination (AC).

Lean Thinking methodology was used with the A3 report tool, and the analysis was carried out by monitoring specific key performance indicators, derived from variables representing highlights of the trials’ activation pathway.

The project involved phases of analysis, implementation of identified countermeasures, and monitoring of timelines in eight 4-month periods.

The overall mean and median values of studies activation times were calculated as well as the average times for each facility involved in the process.

In this study, 298 studies both sponsored by research associations and industry with both observational and interventional study design were monitored.

The mean trial activation time was reduced from 218 days before the project to 56 days in the last period monitored.

From the first to the last monitoring period, each facility involved achieved at least a halving of the average time required to carry out its activities in the clinical trials’ activation pathway (CTC: 55 days vs 23, ECS: 25 days vs 8, AC 29 days vs 10).

Average activation time for studies with agreement remains longer than those without agreement (100 days vs. 46).

Conclusions

The reorganization project emphasized the importance of having clinical and administrative staff specifically trained on the trial activation process.

This reorganization led to the development of a standard operating procedure and a tool to monitor the time (KPIs of the process) that can also be implemented in other clinical centers.

Peer Review reports

Introduction

In the European context, Italy continues to represent a geographical area of great interest for clinical research, an indispensable activity not only for its value in terms of economic investment made in the national territory but also for the opportunity offered to this country to improve clinical practice, grant timely access to therapies to patients, and, more generally, growth.

The scientific excellence of the various Italian trial centers is unfortunately often penalized by the slow process of activating clinical trials, which goes so far as affect Italy’s participation in international studies [ 1 ]. This slowness very often is due to the following: (1) a large number of ethics committees and not always adequate; (2) a lack of availability of research infrastructure including dedicated administrative and clinical staff; (3) a complex regulative process [ 2 ].

Clinical trials can only start if they have obtained a favorable opinion from the ethics committee. In Italy, interventional pharmacological and medical devices studies also require approval from the competent authorities, Italian Drug Agency (AIFA) and the Ministry of Health, respectively. The request for authorization is based on a complete dossier that includes the study protocol and informed consent for the patient as well as all available information about the experimental products, if any. The structure of the trial dossier is standard and meets the requirements identified in European legislation and transposed into national one, which refer to international scientific standards [ 3 ]. State-specific regulations therefore have an impact on the initial phase of trial activation, which therefore makes this phase one of the most complex and costly for sponsors who decide to undertake the initiation of new studies [ 4 , 5 ].

Currently, through the application of the European Clinical Trials Regulation No. 536/14 [ 6 ], this pathway is undergoing a significant reorganization, including a harmonization of clinical trial assessment decisions and administrative processes. This new pathway is fully adopted as of January 2023.

Notwithstanding the quality that a clinical center can demonstrate in the research setting, in terms of qualified personnel and facilities available, the selection of centers conducted by trial sponsors also relies heavily on the timelines required for trial activation. For a clinical center to be selected as a participant in a trial, it must represent an opportunity to provide innovative treatment to its patients. In particular, in trials involving competitive enrollment among participating centers, rapid process for its activation allows a higher rate of recruitment of patients eligible for the experimental treatment.

Difficulties encountered in trial activation have been identified for studies in different therapeutics areas, and pathways have been studied for both industry-sponsored and investigator-sponsored studies [ 7 , 8 , 9 ]. In order to make the centers more attractive, in recent years, some research institutes have carried out projects to internally reorganize the pathway for trial activation, identifying the main critical issues and developing new organizational models with a reduction of the time for the start-up phase of trials [ 10 , 11 , 12 ]. None of these projects have so far been performed in Italian centers.

This study aims at analyzing and reorganizing the start-up phase of trials conducted at the Research and Innovation Department (DAIRI) of the public hospital “SS Antonio e Biagio e Cesare Arrigo” of Alessandria (AO AL) in Piedmont region (Italy).

Materials and methods

In the period from November 2019 to August 2022, a project about the reorganization of the trial authorization process was carried out at DAIRI.

Setting and participants

This process involved different facilities (clinical trial center, ethic committee secretariat, and administrative coordination), everyone with specific roles. The clinical trial center (CTC) was responsible for conducting an assessment of the trial for scientific and economic aspects as well as checking the completeness of the trial dossier provided by the sponsor. Once the assessment has been carried out, the CTC forwards the trial documentation to the secretariat of the Ethic Committee (ECS), which was responsible for including it in the first useful meeting of the Ethic Committee (EC) and producing the minutes of approval. The administrative coordination (AC) was responsible for negotiating the agreement when required and preparing the authorization act for the conduct of the trial at AO AL.

Prior to the start of the project, in September 2019, the trial activation process consisted of these three phases that took place consecutively, and the average time of this process at the hospital was 218 days.

Lean methodology

The system development methodology refers to the Lean Thinking, a new way to organize processes and activities in different scenarios, including HealthCare, in order to eliminate waste and to optimize resources and to create more value to individuals [ 13 , 14 ].

Lean Thinking encourages the practice of continuous improvement and is based on the fundamental idea of respect for people. The basis of performance management is the effective use of resources, as measured by quantifying processes and outcomes using key performance indicators (KPIs) [ 15 ].

We used the “A3 report” both in the communication process within the team and as a tool for describing, analyzing, and solving the problem (see Additional file 1 : Table S1).

The A3 report reflects the results of the whole process, in several different steps:

Problem description: to clarify the problem and briefly describe it

Current situation: to describe the current situation in the area where the issue appears and to map the process as it is

Root cause analysis: to know and fight the root cause of the problem

Targets/goals: to set goals and step by step to go to the end, also by coming back to previous step and add more details to the initial goals

Countermeasures: to find and apply solutions

Implementation: to present an implementation plan of the actions that will be applied

Results/follow-up: to measure the results and confirm the effect of the applied countermeasures; the step is crucial to set up a continuous improvement

In order to measure and quantify the process improvement, we chose appropriate KPIs (Table 1 ), and we monitored them by using a graphical dashboard.

The project

In the first phase of the project, the trial activation process was reviewed as a whole, and all the steps were evaluated to identify initial countermeasures with the aim of streamlining processes and reducing waste. In the second phase of the project, the implementation of the identified countermeasures and the beginning of the new trial activation process was initiated.

After testing these countermeasures, a monitoring period (November 2019–February 2020) of the timeframe of studies activation was carried out, from which additional and more refined countermeasures useful for achieving process standardization emerged. Following the introduction of the last countermeasures, a new phase of monitoring the timing of trial activation started (May 2020–September 2020).

The monitoring period continued even throughout 2021 until August 2022. We defined further six quarters, from September 2020 to August 2022. In each period, we considered all the studies submitted to the local EC.

In order to monitor the timelines related to the process of trials’ activation, a database already in use at the CTC for monitoring active studies was implemented. The variables identified for timing monitoring were based on the activities carried out by the three facilities (CTC, ECS, AC): date of receipt of trials’ documentation, date of completion of documentation and economic and scientific evaluation, date of transmission of trials’ dossier, date of ethics committee meeting, date of issuance of approval minutes, date of start and end of agreement negotiation (if any), date of authorization by the AO AL, date of last signing of the agreement. We considered all trials sponsored by companies or non-profit institutions. For studies sponsored by AO AL, the time of study design and planning was not considered; thus, the time of activation was monitored, since the protocol and attached documents were completed.

The overall mean and median values of studies activation times were calculated as well as the average times for each facility involved in the process. Median activation time values were also calculated by dividing studies with and without an agreement.

During the eight periods between November 2019 and August 2022, 298 trials were monitored (Table 2 ).

Of these, 282 were activated at AO AL, while 13 received conditional or suspensive opinion from the local EC with no response from the sponsor within the defined timeframe, 2 received a negative opinion from the national competent authority (i.e., AIFA), and 1 was withdrawn by the sponsor.

Of the 298 studies, 98 were interventional (e.g., studies on the evaluation of innovative drug therapies or medical devices or the study of diagnostic, surgical, or assistive procedures). The other 200 studies were epidemiological or observational pharmacological or observational medical device studies. Regarding the nature of the studies monitored, 56 were for-profit, while 242 were sponsored by research associations or no-profit organizations. Of all the studies considered, 100 involved the signing of an agreement between the sponsor and the AO AL to conduct the study, not only limited to industry-sponsored studies.

The 298 studies examined in the project were not related to COVID-19 because all trials on this specific topic followed a faster activation process due to national regulations.

As a result of the reorganization project, the mean trial activation time was reduced from 123 and 110 days in the first two periods monitored to 56 days in the last period from May to August 2022 (Fig. 1 ).

Mean and median activation times of the trials considered in each monitoring period

Median values decreased from 81 days in period I to 55 days in period II to 31 days in the last two periods monitored.

Average times recorded for carrying out the activities of each individual sector in the first and last monitoring period of the trial activation pathway

The average time to carry out CTC activities decreased from 55 to 23 days. The time between the completion of the documentation by the CTC and the submission of the study to the EC cannot be less than 15 days because this is a fixed time stipulated by the study activation procedure. The time required for the ECS to issue approval has decreased from an average of 25 days to 8 days. The time required for approval by the institute, carried out by the AC after EC approval, decreased from an average of 29 days to 10 days.

The activation process for studies that do not involve an agreement between sponsor and AO AL has gone from an average time of 91 days in the period from November 2019 to February 2020 to an average of 47 days in the last time frame. The average time frame for activation of studies with agreement has decreased from 159 days in the initial phase to 100 in the last period considered (Fig. 3 ).

Comparison of the average activation time of trials with and without agreement in the first and last monitoring period

The agreement finalization time (from the beginning of text negotiation to final signature) decreased from 117 to 69 days in the last monitored period.

The current average time of the clinical trial activation process is 56 days and is more influenced by the larger number of studies that do not have agreements and therefore take less time to complete the activation process.

Analyzing the data according to the type of sponsor, studies promoted by industry went from an average activation time of 195 days in the first project monitoring period to 122 days in the final one. In comparison, studies promoted by institutions went from an average activation time of 106 days in the period between November 2019 and February 2020 to 50 days in the period between May 2022 and August 2022 (Fig. 4 ).

Comparison of the average activation time of industry or institution promoted trials in the first and last monitoring period

At the DAIRI in the Piedmont Region (Italy), a project of the reorganization of the start-up phase led to a reduction from 218 to 56 days of the clinical trial activation process.

During the course of the project, an implementation and reorganization of the staff was also carried out. The turnover of staff involved in this process had a negative impact on the average timelines for the last quarter of 2020 and the first quarter of 2021. This critical issue was agilely overcome thanks to the expertise developed by the working group composed by healthcare (e.g., biologist, research coordinators and data mangers) and administrative staff, which enabled the new staff involved to be trained quickly. This can be observed because the average times monitored in the second quarter of 2021 decreased further compared to those in the second quarter of 2020.

The importance of having trained staff in these specific activities was also observed in another reorganization project [ 10 ].

Despite the fact that the project was conducted during the COVID-19 pandemic, we did not identify any factors related to this that may have positively or negatively influenced the average timing of the activation phase of the studies. The studies on this specific topic were not included in the project precisely to avoid a bias because the COVID-19 trials’ activation process was fast-tracked, given the emergency status, according to national legislation.

Active participation in the project to reorganize the clinical trials’ authorization process by all the staff of the three facilities involved enabled them to gain the ability to analyze any criticalities that arise along the way and, through discussion in scheduled meetings, to develop additional countermeasures to facilitate the process.

Among the countermeasures taken that led to the reduced timelines was the identification and training of a group of data managers who check the completeness and assess the suitability of documents before the EC meeting, maintaining contact with the sponsor, principal investigator, clinical research organization (CRO), and ECS. This reduced the number of documentation integration requests from the EC, making the ethics approval phase faster.

In a further move to streamline the EC approval process, ECS compiles a draft opinion before each EC meeting, and once the study is approved, the approval is digitally signed by the EC chair.

The most effective countermeasure applied was to no longer run a linear pathway but to run it in parallel across sectors, as found in similar reorganization projects [ 10 , 11 ]. According to the current process, the negotiation of the agreement begins in parallel with the evaluation conducted by the CTC, so that once the trial can be forwarded to the EC, the text of the agreement has already been finalized between the AO AL and the promoter (or its delegate). In addition, in order to simplify the agreement negotiation phase, the institution decided to adopt the draft agreement issued by the national authority in charge of drug studies (AIFA) and propose its use to sponsors and CROs.

Finally, in view of the fact that more and more sponsors are requesting digital signature of the agreement, it has been fully adopted, and the director general of the institute has delegated the signing of clinical trial agreements to the head of the AC.

A factor that influences the average timing of the activities carried out by the CTC is the parallel submission of interventional drug trials to the competent authority, coordinating ethics committee, and satellite ethics committee: according to regulations of the local ethics committee, it was not possible to release the approval until it was acquired the favorable approval issued by the coordinating EC. In the case of interventional drug trials, many times the documentation was taken over by the CTC, which carried out the scientific-technical evaluation but then could not proceed to submit the study to the EC.

This delay was eliminated with the full entry into force of the European Clinical Trials Regulation No. 536/14, which, for the activation of this specific type of study, removes the need to submit a trial to several ethics committees in the same country, requiring the approval of only one [ 6 ].

The time required to activate a trial is even longer for studies with agreement, because after approval by the institution, there are additional steps, which also depend on the rapidity of the sponsor’s response. This has also been highlighted at other centers that have conducted an analysis related to the management of the trial activation process [ 9 , 10 , 11 ].

Comparing the time reduction achieved with that found in other projects [ 12 ], it can be considered that the reorganization of the trial activation pathway was successful and that the pathway was fully standardized.

In conclusion, to the best of our knowledge, this is the first study to analyze and improve the clinical trial activation process in Italy, using the lean thinking methodology.

This study reported an analysis of the clinical trials’ activation pathway in a public hospital of Alessandria in northern Italy. Lean approach allowed a reduction from 218 to 56 days, from documentation intake to authorization act. The hospital includes a Research and Innovation Department characterized by a research infrastructure with facilities as centralized clinical trial center and administrative coordination equipped with dedicated and qualified clinical and administrative.

The reorganization of the complex regulative process led to the development of a standard operating procedure and a tool to monitor the KPIs of the clinical trial activation process that can also be implemented in other clinical centers.

Availability of data and materials

Raw data were generated at DAIRI. Derived data supporting the findings of this study are available from the corresponding author CP on request.

Abbreviations

Research and Innovation Department

Clinical trial center

Ethics committee secretariat

Administrative coordination

Key performance indicator

Italian Drug Agency

Public Hospital “SS Antonio e Biagio e Cesare Arrigo” of Alessandria

Ethic committee

Clinical Research Organization

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Pelazza, C., Betti, M., Marengo, F. et al. The clinical trial activation process: a case study of an Italian public hospital. Trials 25 , 240 (2024). https://doi.org/10.1186/s13063-024-08059-z

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