The recent pandemic taught the world that the future of healthcare depends on clinical research. Effective clinical research depends on data – the currency of the digital age, a force that has transformed the healthcare research landscape. Data is where the future of healthcare lies.
The critical need for clinical data management, validation, review, reconciliation, transfer, coding, and analysis means that every aspect of data handling demands the highest degree of precision.
Esculape GmbH stands for said precision. Welcome – your, trusted, reliable partner in clinical data management. The era is transforming swiftly. Advancing at the forefront of healthcare research, a bold vision, and a resolute commitment to innovation are distinctive characteristics of Esculape GmbH. It is redefining how data is managed to enhance healthcare delivery. Combining cutting-edge technology, data-driven solutions, and patient-centric design, the company is addressing some of the most pressing challenges in global health.
Driven by a mission to make healthcare smarter, more efficient, and more human, Esculape GmbH develops digital platforms and tools that empower both providers and patients. From high-quality data solutions and advanced diagnostics to streamlined clinical workflows, the technology is designed to improve outcomes, reduce complexity, and support meaningful progress in healthcare research.
With a team of clinical research specialists and data science professionals, Dr Marina Mangold, a distinguished Senior Clinical Research Professional and the visionary CEO leads Esculape GmbH with agility, ethics, and impact. A strong background in clinical research and a passion for advancing healthcare innovation prove that Dr Mangold has been instrumental in steering Esculape GmbH towards becoming a leading force in the digital health landscape.
Her expertise bridges science, strategy, and technology, enabling her to lead with precision and purpose. Under her leadership, Esculape GmbH is transforming healthcare delivery through intelligent, patient-focused solutions that are shaping the future of global health. The spirit of innovation and growth continues to define the company’s journey. The company is not only expanding its reach across the healthcare landscape, but also evolving internally – most recently by integrating Data Science capabilities into its Data Management department. This strategic development has significantly optimized internal processes, enhanced analytical depth, and enabled the delivery of more tailored and efficient solutions for clients. It’s a clear reflection of Esculape’s ongoing commitment to progress – both in terms of service quality and operational excecllence.
Esculape GmbH’s Plethora of Services: A Comprehensive Approach to Clinical Data Excellence
Esculape GmbH stands at the forefront of clinical research support, offering a wide array of specialized services that reinforce data integrity, regulatory compliance, and operational efficiency in clinical trials. With a deeply rooted commitment to ensuring patient safety and data quality, Esculape GmbH’s services span across every crucial touchpoint in the clinical data lifecycle, from design to delivery.
At the heart of Esculape GmbH’s service portfolio lies Clinical Data Management, where the integrity of data is treated as paramount. Understanding that accurate, reliable data is fundamental to both patient safety and future therapeutic decisions, Esculape GmbH ensures comprehensive oversight at every stage. Clinical trials involve various stakeholders—each contributing to the generation and modification of study data—and Esculape GmbH acts as the trusted partner who brings structure and quality to this complexity. Whether supporting pharmaceutical companies, clinicians, or CROs, Esculape GmbH offers tailored assistance to streamline the study process and safeguard data quality from the outset.
The company’s Data Management Oversight service exemplifies its value to sponsors, particularly those lacking full-time data managers. As sponsor oversight is a non-delegable responsibility, Esculape GmbH steps in to offer hands-on guidance, from CRO selection to project audits. Their team meticulously reviews all CRO-generated documentation, conducts User Acceptance Tests, and liaises with vendors on eCRF design, reconciliation protocols, and timeline management. Additionally, Esculape GmbH evaluates vendor proposals and monitors costs, ensuring every decision aligns with the sponsor’s expectations and regulatory obligations.
Esculape GmbH also offers expert guidance in various EDC (Electronic Data Capture) systems, including vendor selection, requirements analysis, system validation (Computerized System Validation), and execution of User Acceptance Testing. Their technical acumen ensures that sponsors adopt the right tools for data collection while meeting stringent compliance and usability standards.
For organizations looking to strengthen their regulatory framework, Esculape GmbH offers SOP Development and Audit services. They assist in crafting Sponsor Oversight SOPs and practical, hands-on SOPs for CROs and sponsors alike, designed to ensure compliance with ICH-GCP as well as EMA and FDA regulatory expectations. Their auditing services ensure project compliance and readiness, bolstering confidence during regulatory reviews.
Esculape GmbH further extends its impact through Lead/Project Data Management services. Acting either on an interim or long-term basis, they assume full responsibility for traditional data management functions. Their offerings include CRF development, Data Management Plan creation, data validation strategies, query management, reconciliation activities, and final data management reports. They even offer coding services upon request. This level of support enables CROs and sponsors to maintain data quality without overstretching internal resources.
In the realm of Data Privacy, Esculape GmbH provides specialized consulting for clinical research settings. They offer services such as acting as external data protection officers, conducting audits, developing policies, and integrating data privacy processes within Quality Management Systems. Their “helping you help yourself” model empowers internal teams to eventually manage data protection responsibilities independently.
Finally, Esculape GmbH emphasizes capacity building through Training Programs. Upon request, they conduct sessions covering the fundamentals of data management, sponsor oversight, and data integrity in clinical studies. These training programs are designed to instil best practices and reinforce compliance culture within research teams.
Through this wide spectrum of services, Esculape GmbH positions itself as a vital ally in clinical research—fostering data integrity, empowering sponsors, and advancing the future of healthcare with precision and professionalism.
Enabling the Foundation of Good Clinical Research
Esculape GmbH began with a clear vision. Driven by a passion for improving patient outcomes, Dr Mangold quickly realized that reliable, high-quality data is the foundation of successful clinical research. “If we want research to truly translate into better treatments,” she says, “We need to get the data right.” That drive to ensure data integrity and support meaningful discoveries is what led her here.
Emerging as a key player in shaping dara-driven healthcare research, at Esculape GmbH, everything starts with data quality. “We believe that impactful clinical research depends on accurate, well-managed data – without that, even the best studies can fall short,” says Dr Mangold, adding that their commitment to reliability, transparency, and true partnership with their clients has been key to their success.
Embracing Evolution
Staying ahead is imperative in a continuously evolving healthcare research landscape. To Esculape GmbH’s team means constantly learning and evolving. They keep a close eye on industry developments, invest in training, and maintain strong relationships with researchers and healthcare professionals. That way, “We’re always ready to adapt and bring forward innovative solutions that meet real-world needs,” adds Dr Mangold, whose trusted leadership style is often recognized as an inspirational force behind the company’s success and achievements.
“I believe that the best ideas come from collaboration, especially when diverse perspectives are involved.” Her approach is to foster an environment where everyone feels valued and encouraged to contribute. She thinks it’s crucial to have interdisciplinary teams, as they bring a wide range of expertise to the table. “When people are given ownership of their work and the freedom to innovate and grow, they’re able to bring their best ideas forward – and that’s what drives success.”
Solving Problems by Inculcating Sustainability
The essence of healthcare lies in bringing innovation and advancements to the niche one is working in. To strike a balance between solutions offered and customer expectations and experience, the Esculape GmbH team started by listening. Every client has unique needs, and their job is to understand those needs first, insists Dr Mangold. Innovation isn’t about forcing new tech into a process, she adds. “It’s about finding the best way to solve a problem while ensuring a smooth experience for our clients.”
Sustainability is also deeply embedded in how Esculape GmbH operates. It takes a digital-first approach to minimize waste, optimize resources, and streamline processes. For instance, by managing its own server, the company has greater control over the amount of data it stores and how efficiently it uses energy. “This allows us to be more mindful of our environmental impact.”
Enhancing Healthcare Research
Achieving remarkable success means always being committed to excellence and innovation through the completion of transformative projects. When asked to highlight one of them, Dr Mangold says, “We’re really proud of everything we do.”
While they’re always open to exploring new areas, breast cancer has been their main focus for some time, simply because there are so many important studies underway. It’s incredibly fulfilling to be part of so many of them and help push them over the start line and, eventually, across the finish line. Esculape GmbH’s work spans various phases of clinical trials and observational studies, with a diverse range of projects that highlight its commitment to innovation and excellence in clinical research.
In the realm of healthcare research, technology plays a pivotal role in enhancing efficiency. Esculape GmbH leverages advanced digital tools to streamline data collection, validation, and analysis. The right technology helps it work faster, reduce errors, and ultimately improve the reliability of clinical research. It uses technologies that are readily available and meet its strict requirements in the clinical data world. It’s not about reinventing the wheel or using tech for its own sake – it’s about making processes better, emphasizes Dr Mangold.
Empowering Team to Triumph Challenges
Furthermore, believing that the workforce is the cornerstone of any successful healthcare organization, she ensures that they invest in continuous learning, encourage knowledge sharing, and create opportunities for professional growth. When people feel supported and challenged, they bring fresh ideas to the table – and that benefits everyone, she states.
Thus, when challenged, an empowered team makes all the difference. Dr Mangold shares an instance where her team’s resilience and ingenuity triumphed over adversity. During a particularly high-pressure project, they ran into unexpected data inconsistencies that could have delayed everything. Instead of panicking, the team worked together, tackled the problem from multiple angles, and quickly found a solution. “It was one of those moments that just reinforced how strong and capable our team is.”
The COVID-19 pandemic has reshaped industries globally. Also, currently, escalating geopolitical scenarios are adding to the uncertainties. When asked about Esculape GmbH’s contingency plan, Dr Mangold stated that they already were ahead of the curve when it came to flexible working, having established remote work options from the beginning in 2015, long before the pandemic. This made the transition to full remote work much smoother when the world changed.
While they don’t fully operate remotely, with some team members working in the office full time, others still take advantage of the option to work remotely two days a week. They’ve always prioritized flexibility to accommodate everyone’s needs. Over the years, they’ve built a strong digital infrastructure to support this and ensure that they’re well-prepared for any uncertainties ahead – whether it’s a global crisis or shifting industry regulation.
Esculape GmbH’s Advice and Vision for Future
Businesses are a way to enhance entrepreneurial capital in the healthcare niche. So, Dr Mangold’s advice to budding entrepreneurs wishing to enter her niche is to focus on delivering real value and maintaining high standards. ‘Healthcare is built on trust, and success comes from prioritizing quality and integrity. Surround yourself with a great team – collaboration and support are everything in this field.’
Finally, Dr Mangold shares her vision for Esculape GmbH. “We want to keep growing, innovating, and setting new standards for clinical data management.” She concludes, “By staying true to our commitment to quality and expanding our reach, we aim to make an even greater impact on healthcare research.”
For further communication, email to vanessa.pitz@ctms-esculape.de.