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 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.
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.
CLINICAL SPECIALISTS, MEDICAL PROFESSIONALS, AND PROBLEM SOLVERS.
Maria Nyåkern, Ph.D.
Founder and CEO, Principal Scientist
David Tomé, MBA
Chief Operating Officer (COO)
Diana Posa, Pharm.D
Clinical Affairs Manager
Amalia Meseguer, Pharm.D
Clinical Reserach Project Lead
Ariadna Navarro, Ph.D.
Regulatory Affairs Manager
Jorge Medina, Pharm.D
Clinical Quality Lead
Ruben Ruiz, M.Sc.
Clinical Research Scientist
Almudena Millán, M.Sc.
Business Development Associate
Raquel Cordeiro, Ph.D.
Clinical Research Scientist
Roberto Estébanez, M.A.
Elisa San Isidro, M.Sc.
Clinical Trial Assistant
José Velázquez, M. Sc.
Clinical Research Scientist
Matias Fernandez, MBA.
Market Research Associate
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 every-day work.
- Regulatory Compliance
- Clinical Competency
- Reason and Honesty
- Dignity and Respect
A WELL-TRUSTED PARTNER & GLOBAL EXPERTISE WITH A LOCAL TOUCH
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.
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. We are permanent supporters of Greenpeace and United Nations High Commissioner for Refugees (UNHCR).
As a staunch defender of the natural world, Greenpeace is promoting peace by investigating, exposing, and confronting environmental abuse, championing environmentally responsible solutions, and advocating for the rights and well-being of all people.
United Nations High Commissioner for Refugees (UNHCR)
The UNCHR is working to protect and assist refugees worldwide and is on the ground wherever refugees need help, providing protection and assistance, including emergency shelter, food, water, and healthcare.
“You cannot do a kindness too soon, for you never know how soon it will be too late.”Ralph Waldo Emerson