In the quest for advancing healthcare, ensuring the safety and efficacy of the products before reaching the market is crucial. Clinical research, dedicated to gathering extensive information, is at the heart of this effort. The goal is to ensure that when individuals take medication, they experience the best results with minimal side effects. Collecting more data becomes vital to truly understand its effectiveness and potential side effects, underscoring the importance of clinical research.
Leading in this domain with expertise in managing clinical trial data is Esculape GmbH. Focusing on ensuring reliable and high-quality data, the company plays a pivotal role in the broader field of clinical research, catering to clients from the pharmaceutical industry, medical researchers, and external contract research organizations.
Established in 2015, Esculape GmbH is the brainchild of Dr. Marina Mangold, a seasoned professional with 8 years of experience dedicated to maintaining the quality and accuracy of products, services, and data in the fast-paced world of clinical research. As the CEO, Marina leads the company, leveraging her extensive experience and commitment.
In the intricate world of clinical data management, Esculape’s unique approach has not only defined its success but also positioned it as a model for fostering a healthy work environment in the healthcare industry.
Dive into the inspiring story of Marina to learn about the establishment of Esculape GmbH and its commitment to excellence in the niche.
From Microbiology to Clinical Data Mastery
In the pursuit of research, Marina, a microbiologist turned clinical data expert, embarked on a unique journey that led her from the world of biology and microbiology to the dynamic field of clinical research. After completing her PhD in molecular biochemistry in the microbiological field, Marina realized that a university career wasn’t her ultimate goal. Instead, she sought to carve her niche within the expansive world of research, particularly in clinical studies.
Marina’s venture into clinical research started fifteen years ago. Initially working as a salesperson, she stumbled upon a clinical research company without a clear understanding of its operations. In her application interview, she expressed her research interest, admitting, “I don’t know what you do, but I’m sure I can learn.” This marked the beginning of her enduring journey in the clinical research landscape.
Specializing in the intricate field of data management, Marina plays a crucial role in the entire study process. From the early stages of study design discussions, she collaborates with the data management team to ensure efficient data collection. While the job might seem routine to some, Marina sheds light on its complexity, especially as the clinical system market evolves. With multiple systems involved in a clinical study, Marina’s role extends beyond understanding the medical and research aspects; it delves into the field of IT, necessitating a profound understanding of data exchange and flow between systems.
The Birth of Esculape GmbH
The founding story of Esculape is a journey that began with a quest for balance between work and family. After the birth of her son, Marina transitioned from a freelancer to the founder of Esculape GmbH. Her vision was clear: to create a space where work and life could coexist harmoniously.
Right from the inception, Marina instituted a revolutionary policy—equality in remote work accessibility for every team member, from the CEO to interns. This commitment, established seven years ago, preceded the widespread adoption of remote work seen during the pandemic. Marina reflects, “And I know after the pandemic, that’s obvious, and everybody gets that. But seven years ago, when I started all this, it was not obvious.” This forward-thinking decision laid the foundation for team growth, attracting individuals passionate about their work and dedicated to delivering quality with a genuine work-life balance.
Esculape, though a small company, stands out for its specialized focus on clinical data management services. With a client base primarily comprising smaller pharma companies and startups, Esculape is the go-to choice for organizations aiming to sell or approve products, be it a ground-breaking biotech endeavor or a larger pharmaceutical initiative.
Ensuring Data Quality in Clinical Trials
In the dynamic landscape of healthcare, the team at Esculape is pioneering a novel approach to data management. Their focus centers on the development of an internal data review tool designed to keep a vigilant eye on the pulse of each trial, ensuring data quality and integrity.
Marina, the driving force behind Esculape, shares insights into their methodology, emphasizing their proficiency in handling diverse clinical systems and data entry mechanisms. “We are experienced with different clinical data entry systems, knowing how to set them up, retrieve data, aggregate, and prepare it for analytics,” she explains. While the field they operate in is highly specialized, Marina distinguishes Esculape by their decision not to develop an in-house system.
In unveiling their strategic approach, Esculape stands out as a symbol of transparency, expertise, and a dedication to collaboratively sharing knowledge in the complex field of clinical data management.
Navigating Workforce Challenges and Embracing Authenticity
Marina sheds light on a common challenge within her company and throughout Europe, especially in Germany. The shortage of qualified personnel poses a persistent question: is the talent truly lacking, or are organizations searching for the wrong skills?
Marina’s strategy to address this challenge is marked by openness and authenticity. Recognizing that rigid office hours hinder potential candidates, especially women seeking part-time roles, she defied conventional norms. Marina states, “I allow women to apply who were not interesting for other companies at all because they just said, well, I cannot be in the office all day and I can only work, let’s say, 15 to 20 hours per week.”
Authenticity, for Marina, is not just a strategy but a way of being. In a team where individuals are not mere numbers but valued contributors, honesty about job expectations and a commitment to fostering a learning environment have been instrumental. In addressing the persistent challenge of finding the right people for the job, Esculape’s 2024 strategy includes an innovative online training program. Marina shares, “The people who know how to do this job are not there, so we started an online training program to, let’s say, allow people to learn this job.” This initiative aims to bridge the gap in skill sets and create a diverse, qualified talent pool.
The challenges faced by Esculape during the COVID-19 pandemic add another layer to their narrative. Engaged in pivotal projects related to the development of COVID-19 vaccinations, the team seamlessly transitioned to remote work from day one. Marina reflects, “We were already remotely connected and used to it. So, we were able to decide to go home and go on with our work within hours without the need to establish new software or connections.”
New Horizons
Enthusiastically, Marina outlines the strategic shift her team is making. “We did offer a lot of clinical data management services in the last years, but now, we’ve learned that we really will focus on delivering clinical data management oversight services for biotechs and pharma companies. That’s our key message, and that’s what we want to sell and do from now on.”
She notes the expanding market, stating, “We started in Germany and, in the last one or two years, spread over Europe. Looking ahead, we aspire not only to cover Europe but also wish to enter the US market. Supporting biotech companies is our key message, and we see significant growth potential in that.”
Marina emphasizes the importance of confidence in scaling operations. “We’re gearing up for a significant year in 2024. We plan to offer a course for onboarding and training future data managers for CROs and interested individuals. Additionally, we aim to enhance our data review tool to support studies in the most efficient way possible.”
Nurturing Skills, Commitment, and Flexibility
Reflecting on her journey, Marina shares, “First of all, I’ve gained relevant clinical research knowledge and a good framework of data management and computerized system validation skills and understanding.” She emphasizes soft skills such as thinking outside the box and integrating knowledge from diverse roles into her current position as a Sponsor Oversight Supporter, with a primary focus on data management but not limited to it.
Marina highlights her strength: “One of my strengths is that I can quickly collect information and combine different pieces of information that, on the first view, might seem unrelated. I use this ability to make quick decisions and once made, I stick to them.” She believes in the significance of commitment and decision-making, stating, “We usually do not know if a decision we make is right or wrong. But when you stick to a decision, it usually turns out to be the right one because it’s just a question of goal.”
Marina extends her approach to her team, emphasizing the value of providing the same opportunities she enjoys. “Whoever applies for a job, I always let them know, ‘Let me know how many hours per week you want to work.’ I allow my whole team this flexibility. I have, I think, only one person being full-time and the others being part-time, whatever fits into their lives. This might change over time when circumstances change. This is something I allow my team because I want to have it for myself, and I allow others what I take for myself as well. And that’s not only for women but also for men.”
Wisdom from Marina
Marina offers valuable advice, saying, “One of my pieces of advice would be to try a smaller company before spreading your wings in bigger ones. It’s tempting to aim for a big name on your name card, but being part of a small team where you can learn the entire area can be more beneficial. Gain experience, figure out your preferences, and then apply for a specific job in a larger company. While starting in a bigger company may seem advantageous for future promotions, a quicker learning curve in a smaller company might lead to a comparable position sooner. That would be my advice.”
Reflecting on her own aspirations, Marina shares, “For me, success by 2030 is being happy and content with my job. While others might express aspirations for growth into larger regions, my grandmother’s wisdom resonates with me. Feeling satisfied is crucial.”
She encourages an open-minded approach, stating, “Be open-minded and try to get on board in a small company – you will learn a lot.”
Marina concludes with a reflection on the importance of diversity in clinical trials, stating, “Seeing people as they are and allowing them to be who they are is the key to success and well-being.”
Pioneering Excellence—Esculape’s Ongoing Contribution to Healthcare
Marina envisions expansion through increased visibility and sharing, “We plan to be more active on LinkedIn, participate in more congresses, and deliver more speeches. Our goal is to inform people about the services we offer because many are unaware that such services exist. When we introduce our role in assisting companies working with larger CROs in managing data, the response is often gratitude for addressing their challenges. Our service is not widely known, so spreading this awareness is our priority.”
Looking ahead, Marina shares, “We aim to share our knowledge through data management courses. From 2024, our focus will intensify on sponsor oversight in clinical data management, with hopes of expanding services across Europe and possibly into the US.”
