Meet the ÅKRN Team – the MedTech Experts

Grounded in medicine and science, we help sponsors move from medical discovery into clinical development, commercialization, and post-market follow-up.

We provide a high level of expertise, and excellent clinical and regulatory services, in a cost-conscious and diligent manner. Our experience covers a wide range of medical device therapeutic areas, including neuroscience and cardiovascular devices.

We are a multidisciplinary team collectively fluent in more than ten European languages. Our research specialists and clinical professionals have higher scientific degrees, including Ph.D., Pharm.D., and Masters in Clinical Research.

Our team specializes in medical devices and in-vitro diagnostics. We offer a single point of contact, but with the benefit of strong senior management support.

Our success builds upon providing our clients with a combination of medical and technical expertise within tightly controlled clinical studies and budgets. Because of this, our clients and partners view us as a trusted and valued adviser in clinical investigations and regulatory development, and CE-mark strategic consulting.

Maria Nyåkern, Ph.D. Founder & Chief Executive Officer LinkedIn

Diana Posa, Pharm.D Associate Director Clinical Affairs LinkedIn

Ariadna Navarro, Ph.D. Associate Director Quality & Regulatory Affairs LinkedIn

Igor Alonso, Lawyer Legal Counsel LinkedIn

Jorge Medina, Pharm.D Clinical Affairs Manager
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Raquel Cordeiro, Ph.D. Clinical Affairs Manager
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Ruben Ruiz, M.Sc.
Clinical Affairs Manager
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Elisa San Isidro, M.Sc. Clinical Study Manager
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Lucía Gato Ph.D.
Clinical Research Scientist
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Miren Alustiza, Ph.D.
Clinical Research Scientist
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Lucía García, M.Sc. Clinical Research Scientist
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Alejandro Fulgencio, Ph.D.
Clinical Research Scientist LinkedIn

Aitana García-Fresca, M.Sc.
Clinical Research Associate
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Íñigo Marquet, M.Sc.
Clinical Research Associate
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Maite Gómez M.Sc.
Clinical Research Associate
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Álvaro Torcal, M.Sc. Clinical Research Associate LinkedIn

Ángel Navarro, M.Sc. Clinical Research Associate LinkedIn

Laura Martínez, Ph.D. Clinical Research Scientist LinkedIn

Katharina Peters, Ph.D. Clinical Research Scientist LinkedIn

Violeta Lillo, B.Sc. Regulatory Affairs Associate LinkedIn

Héctor Fernández, Ph.D. Sr. Regulatory Affairs Scientist
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Beatriz Rodríguez, Ph.D. Regulatory Affairs Manager
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Arancha López-Pérez, Ph.D.
Regulatory Affairs Scientist
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Catarina Santos, Ph.D. Sr. Regulatory Affairs Scientist
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José Velazquez, M.Sc.
Quality & Regulatory Compliance Specialist
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Ana Margarita Maldonado, Ph.D.
Regulatory Affairs Scientist
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Albert Negrete, Ph.D.
Regulatory Affairs Scientist LinkedIn

Laura Martinez Campesino, Ph.D. Regulatory Affairs Scientist LinkedIn

Our advisory board provides us with the opportunity to acquire relevant insights and advice on our company strategy and services and to address professional and medical expertise and needs. This helps us to drive our expansion strategy and generate actionable deliverables to maximize international collaboration and capture business opportunities.

Roberto Estébanez || New Business and Human Resources LinkedIn

Christina Danielsson || Governance Framework and Medical Expertise LinkedIn

Peter Nilsson || Business Performance, Market, and M&A LinkedIn

As Clinical and Regulatory Experts, we have the professional and ethical responsibility to maintain the highest standards of conduct when we exercise our professional duties. We take pride in upholding and clarifying the laws, regulations, and guidelines of the authorities under which we operate. We know that we play a pivotal role in ensuring compliance with applicable laws and regulations in the development and commercialization of healthcare products.

We honor our core values in this increasingly complex global clinical and regulatory environment. As individual professionals, we are making a positive contribution to public health. We also aspire to embody our code of ethics in our words, actions, and deeds.

The following values transpire in our everyday work.

• Regulatory Compliance
• Clinical Competency
• Credibility
• Objectivity
• Integrity
• Accountability
• Reason and Honesty
• Dignity and Respect

As the founder of the company, Maria Nyåkern, Ph.D., is an inspiring leader who steadily seeks to drive the field of Clinical Research Services forward. After completing her scientific training and doctoral studies in Sweden, Dr. Nyåkern spent 15 years in medical and clinical research in the medical device industry before founding ÅKRN Scientific Consulting.

ÅKRN is a niche CRO (Clinical Research Organization) focused on providing exceptional service and resources to the medical device and diagnostic industries. Our clinical scientists and project managers expediently guide and drive projects through the complete clinical development process through diligent planning and superior execution.

Clinical development can be risky in terms of timelines, so a good relationship and engagement of the CRO in the decision-making process are of crucial importance. The sponsor and the CRO should work hand-in-hand to accomplish established deliverables and allow innovative devices into the market faster. It is a long road that can only be achieved with a win-win scenario, with all parts working together to deliver new therapies to patients in a faster and more efficient way.

To date, ÅKRN is the trusted advisor and partner for many companies to deliver maximum value in their medical device development programs. ÅKRN is a privately-held European CRO, and since its inception, the company has experienced a fast and steady organic growth in employees and establishment in the European market.

Much of our work in the MedTech world is built on a desire to help others, and we work hard every day to deliver innovative and lifesaving technology. As successful members of the community, we also have a responsibility to help those that are less fortunate, and we need to contribute to the common good. For us, it is essential to give back to the communities in which we live and work. This is a cornerstone of our company philosophy.