Bayer Launches Centafore Imaging Core Lab to Revolutionize Clinical Trial Imaging and SaMD Development
Bayer, a global leader in healthcare and life sciences, today officially announced the launch of its Imaging Core Lab under the new brand name Centafore™. This strategic initiative marks a significant milestone in Bayer’s ongoing commitment to advancing clinical trial imaging services and supporting the rapidly evolving field of Software as a Medical Device (SaMD) development. Centafore™ draws on Bayer’s extensive legacy—boasting over 25 years of experience in imaging for clinical trials, having supported more than 200 global studies across various therapeutic areas and phases of drug development. The launch of Centafore™ positions Bayer as a premier, stand-alone imaging solution provider offering customized services to external partners, including pharmaceutical, biotechnology, medical device, and digital health companies.
The formal introduction of Centafore™ comes at a pivotal time as clinical trials grow increasingly complex, requiring sophisticated imaging techniques to enable precise diagnostics, rigorous data analysis, and regulatory compliance. The Centafore™ Imaging Core Lab is uniquely designed to meet these challenges by integrating cutting-edge technology with deep clinical expertise to support everything from early research to late-phase trials and software validation processes.
Attendees at the 2025 Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago will have the opportunity to explore the full scope of Centafore™’s capabilities. From May 30 to June 3, visitors to Bayer’s booth (#24152) can engage directly with the Centafore™ team and discover how the lab’s innovative imaging solutions are shaping the future of clinical research and SaMD development.
Comprehensive Imaging Services Backed by Decades of Expertise
Centafore™ offers an integrated portfolio of services that cover image management, processing, and interpretation. These services are crucial in ensuring that imaging data collected during clinical trials is accurately analyzed and effectively utilized to support decision-making. With expert project management at its core, Centafore™ facilitates seamless communication and coordination among sponsors, investigators, radiologists, and regulatory bodies.
The core lab’s extensive network of imaging specialists, including board-certified radiologists with domain-specific expertise, ensures that studies are managed with clinical precision and scientific rigor. This global reach spans over 50 countries, allowing Centafore™ to support multinational trials and help sponsors navigate diverse regulatory environments and operational complexities.
“Centafore™ represents a significant leap forward in our commitment to enhancing the landscape of clinical trial imaging and advancing the development of new medicines and healthcare solutions,” said Nelson Ambrogio, President of Radiology at Bayer. “By leveraging our extensive experience and expertise, we are dedicated to providing our customers with high quality imaging services that meet their specific needs in clinical research. Through Centafore™, we aim to enhance the reliability of trial outcomes and support informed decision-making in the development of investigational medicines, ultimately benefiting patients and improving their quality of care.”
Supporting a Broad Spectrum of Therapeutic Areas
The services offered by Centafore™ are designed to support a diverse array of therapeutic areas. These include oncology, cardiovascular diseases, central nervous system (CNS) disorders, dermatology, women’s health, pediatrics, and the emerging field of digital health technologies. Such breadth enables Centafore™ to partner with a wide range of companies engaged in the development of innovative therapies and medical devices.
Importantly, Centafore™ is well-equipped to assist clients throughout the entire clinical development continuum—from early-phase research, such as Phase I and II studies, to pivotal Phase III and IV trials. This capability ensures that imaging data is consistently leveraged to generate robust, reproducible, and regulatory-compliant evidence supporting safety and efficacy.
Moreover, Centafore™ offers specialized services tailored to the unique demands of Software as a Medical Device (SaMD) development. SaMD refers to software intended to be used for medical purposes without being part of a hardware medical device, a sector that has seen exponential growth fueled by advances in artificial intelligence, machine learning, and digital diagnostics. By combining advanced imaging analysis with regulatory expertise, Centafore™ helps SaMD developers validate algorithms, assess device performance, and ensure compliance with global regulatory standards such as those set by the FDA, EMA, and other authorities.
Adherence to Regulatory and Data Privacy Standards
Recognizing the critical importance of data integrity and patient privacy in clinical research, Centafore™ operates with a firm commitment to regulatory compliance and data security. The core lab adheres strictly to international standards such as Good Clinical Practice (GCP) guidelines, HIPAA regulations for patient privacy, and GDPR requirements for data protection.
By integrating robust data management systems, encrypted communication protocols, and audit-ready workflows, Centafore™ provides sponsors and clinical research organizations (CROs) with confidence that their imaging data is secure, accurate, and compliant. This approach not only facilitates smoother regulatory submissions but also safeguards patient confidentiality—a fundamental ethical obligation in clinical trials.
Fostering Innovation through Strategic Collaborations
Bayer’s launch of Centafore™ is also closely aligned with the company’s broader strategy to support innovation ecosystems worldwide. As part of these efforts, Bayer has been actively engaging with global healthcare startups and technology partners to co-develop solutions that harness imaging as a transformative tool in clinical research.
Centafore™ made its debut at the European Congress of Radiology (ECR) 2024, where the Imaging Core Lab Services were first introduced to the radiology and clinical research communities. Since then, the core lab has established collaborative partnerships with notable organizations such as OBIO® and Luxsonic Technologies. These collaborations focus on leveraging advanced imaging to optimize clinical trial decision-making and enhance the validation process for software-based medical devices.
Such partnerships underscore Bayer’s commitment to bridging the gap between traditional clinical imaging and emerging digital health innovations, fostering an environment where novel diagnostics and therapeutic approaches can be rapidly and reliably assessed.
A New Era for Clinical Trial Imaging and SaMD Development
The launch of Centafore™ by Bayer marks a transformative step in the evolution of clinical trial imaging services. By offering tailored, technology-driven solutions backed by decades of experience, Centafore™ aims to elevate the quality and efficiency of imaging in clinical research.
This development is timely, given the increasing reliance on imaging biomarkers and digital diagnostics in drug development and patient monitoring. The integration of imaging expertise with SaMD development further positions Bayer at the forefront of the convergence between pharmaceutical research and digital health innovation.
Looking ahead, Centafore™ is expected to play a critical role in accelerating the development of new treatments and technologies that ultimately improve patient outcomes and healthcare delivery worldwide.
Bayer is a global enterprise with core competencies in the life science fields of health care and agriculture. Its mission is to improve people’s lives through science and innovation. With its innovative products and services, Bayer is dedicated to addressing some of the world’s most pressing challenges, including disease prevention and treatment, sustainable food production, and environmental protection.
