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 eight 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 trials and development.

Maria Nyåkern, Ph.D. CEO & President
LinkedIn

David Tomé, MBA.
COO & Director of Business Operations
LinkedIn

Diana Posa, Pharm.D
Clinical Affairs Manager
LinkedIn

Ariadna Navarro, Ph.D. Regulatory Affairs Manager
LinkedIn

Roberto Estébanez, M.A. CFO & Director of Corporate Resources
LinkedIn

Raquel Cordeiro, Ph.D. Clinical Affairs Project Manager and Operations Manager
LinkedIn

Jorge Medina, Pharm.D Clinical Affairs Project Manager and Training Manager
LinkedIn

Ruben Ruiz, M.Sc.
Clinical Affairs Project Manager
LinkedIn

Catarina Santos, Ph.D. Regulatory Affairs Project Manager
LinkedIn

Beatriz Rodríguez, Ph.D. Regulatory Affairs Project Manager
LinkedIn

Héctor Fernández, Ph.D. Regulatory Affairs Project Manager
LinkedIn

Matías Fernández, MBA.
Business Operations Project Manager
LinkedIn

Esmeralda Gómez Corporate Resources Project Manager and HR & QA Lead
LinkedIn

Almudena Millán, MBA.
Corporate Resources Project Lead
LinkedIn

José Velazquez, M.Sc.
Regulatory Affairs Project Lead
LinkedIn

Elisa San Isidro, M.Sc. Clinical Research Scientist Project Lead
LinkedIn

Miren Alustiza, Ph.D.
Clinical Research Scientist Project Lead
LinkedIn

Lucía García, M.Sc. Clinical Research Scientist Project Lead
LinkedIn

Marta Moreno, M.Sc.
Clinical Research Scientist Project Lead
LinkedIn

Ana Margarita Maldonado, Ph.D.
Regulatory Affairs Project Lead
LinkedIn

Albert Negrete, Ph.D.
Regulatory Affairs Project Lead LinkedIn

Aitana García-Fresca, M.Sc.
Clinical Research Associate
LinkedIn

Íñigo Marquet, M.Sc.
Clinical Research Associate
LinkedIn

Lucía Gato Ph.D.
Clinical Research Associate
LinkedIn

Laura Martinez Campesino, Ph.D. Regulatory Affairs Project Lead
LinkedIn

Arancha López-Pérez, Ph.D.
Regulatory Affairs Project Lead
LinkedIn

Violeta Lillo, B.Sc.
Regulatory Affairs Associate LinkedIn

Mercedes Sánchez
Corporate Resources Associate
LinkedIn

Sofía López, M.A.
Business Operations Associate
LinkedIn

Alicia Triguero, M.Sc. Business Operations Associate
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 every-day 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.

The 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 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.

To learn about recent projects, please click here.