Who we are – Our team – Code of Conduct – Our history – Our community
Who We Are
MEDICAL EXPERTS IN KEY THERAPEUTIC AREAS
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.

Our Team
Our team has solid knowledge in the clinical research industry, with the insight and expertise to help you meet your goals. With extensive experience in regulatory consulting solutions, clinical services, and other expertise across the medical device spectrum, our experts are passionate about supporting small and emerging medical device sponsors like you. Do you need ballpark pricing, a comprehensive proposal, or a strategic review of your clinical protocol or clinical evaluation plan?
Reach out to our team, and we will support you
MANAGEMENT TEAM

Maria Nyåkern, Ph.D. Founder & Executive Director LinkedIn

Diana Posa, Pharm.D Associate Director Clinical Affairs LinkedIn

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

Matías Fernández, MBA
Business Development Manager LinkedIn

Raquel Cordeiro, Ph.D. Clinical Affairs Manager
LinkedIn

Ruben Ruiz, M.Sc.
Clinical Affairs Manager
LinkedIn

Elisa San Isidro, M.Sc. Clinical Study Manager
LinkedIn

Lucía García, M.Sc. Associate Manager Clinical Studies & IVD team lead
LinkedIn

Beatriz Rodríguez, Ph.D. Regulatory Affairs Manager
LinkedIn

José Velazquez, M.Sc.
Quality Assurance Manager LinkedIn

Catarina Santos, Ph.D. Sr. Regulatory Affairs Scientist
LinkedIn

Esmeralda Gómez Human Resources Manager
LinkedIn
ASSOCIATES

Alejandro Fulgencio, Ph.D.
Clinical Research Scientist LinkedIn

Íñigo Marquet, M.Sc.
Clinical Research Scientist
LinkedIn

Maite Gómez, M.Sc. Clinical Research Associate
LinkedIn

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

Maria de los Angeles Vargas, Ph.D.
Clinical Research Scientist LinkedIn

Violeta Lillo, B.Sc.
Regulatory Affairs Associate LinkedIn

Arancha López-Pérez, Ph.D.
Regulatory Affairs Scientist LinkedIn

Albert Negrete, Ph.D.
Regulatory Affairs Scientist LinkedIn

Ana Margarita Maldonado, Ph.D.
Regulatory Affairs Scientist
LinkedIn

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

Jairo Ruiz M.Sc. Clinical Research Associate LinkedIn

Fernando Pelarda, M.Sc.
Regulatory Affairs and Quality Assurance Associate
LinkedIn

Izarne Medina, Ph.D.
Regulatory Affairs Associate LinkedIn

Marina Tapias, M.Sc. Clinical Research Associate LinkedIn

Daniel Gil, Clinical Trial Assistant LinkedIn

Emma Cordón, M.Sc. Clinical Trial Assistant LinkedIn

Claudia Artiaga, M.Sc. Clinical Research Associate LinkedIn

Laura Sanchez-Rivera, Ph.D.
Regulatory and Clinical Research Fellow LinkedIn

Jorge Delgado, M.Sc. Regulatory and Clinical Research Fellow LinkedIn

Joana Serrão, Ph.D.
Regulatory and Clinical Research Fellow LinkedIn

Iñigo Sánchez M.Sc.
Regulatory and Clinical Research Fellow
LinkedIn

Maria Neves, Ph.D.
Regulatory and Clinical Research Fellow
LinkedIn

Luis del Rio Garcia, M.Sc. Regulatory and Clinical Research Fellow LinkedIn

Ana Ortiz, Ph.D. Regulatory and Clinical Research Fellow LinkedIn

Juan Pablo Medina, Ph.D.
Regulatory and Clinical Research Fellow LinkedIn

Pablo Arranz, Ph.D. Regulatory and Clinical Research Fellow LinkedIn

Guillermo Amate, Ph.D.
Regulatory and Clinical Research Fellow LinkedIn

Julian Ortiz, MBA. Business Development Associate LinkedIn

Lucía Gonzalez, MBA.
Business Development Associate LinkedIn

Stefania Suarez, MBA. Business Development Associate LinkedIn

Mercedes Sánchez, MBA.
Finance Associate
LinkedIn

Laura González.
Office Manager
LinkedIn
Code of Conduct
STATEMENT OF PERSONAL RESPONSIBILITY
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
Our History
A WELL-TRUSTED PARTNER WITH GLOBAL EXPERTISE
As the founder of the company, Maria Nyåkern, Ph.D., is an inspiring leader who steadily seeks to drive the field of clinical research consulting 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 AKRN Scientific Consulting.
AKRN is a 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, AKRN is the trusted advisor and partner for many companies to deliver maximum value in their medical device development programs. AKRN 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.
Our Community
WE ASPIRE TO HELP OTHERS AND IMPROVE PEOPLE’S LIVES
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.
“You cannot do a kindness too soon, for you never know how soon it will be too late.”
Ralph Waldo Emerson