Excellent Team and Strong Operational Performance
We ended 2020 with significant momentum, which is expected to continue in 2021 with a pipeline of exciting new regulatory projects and clinical investigations of life-saving medical devices.
AKRN had another successful year with impressive growth thanks to its diversified service portfolio and advancement of key services.
Contributing to our success was the increased activity in regulatory services with ten times increase revenue in this area; mainly driven projects related to Software as Medical Devices.
Our growth was also fueled by our core competence in project management of global clinical investigations of medical devices. We continued to support European and North American medical device manufacturers with project management, regulatory submissions, and monitoring of clinical studies in Europe.
Our repeat business ratio is very high, and we continue to offer value to our long-term clients. In addition to that, we brought in new business, and we tripled our client base to include several new clients from Latin America, United States, the European Union, and Israel.
Most importantly, during 2020 we continued to invest in our organization. We are building a resilient team that offer sustainable and robust performance — withstanding even uncertain times.
In 2021 we expect to maintain our growth by reinvesting in our employees’ continued development. We are also continuing to invest in more internal structure and we are further developing and scaling-up our staffing capacity.
Highlights from 2020
- GROWING THE TEAM
We recruited several new talented scientists and business professionals; young and motivated people with life-science degrees, PhDs, MBAs, and post-graduate masters in clinical research were onboarded during 2020.
- SETTING UP MDD TO MDR TRANSITION PROJECTS
The ten-fold increase of regulatory services was driven by the demand for activities related to the development of Technical Documentation, MDD to MDR Gap Analysis, Roadmaps to CE mark, and Clinical Evaluation Reports (CERs).
- DEVELOPING NEW IVD PROJECTS
About 22% growth in regulatory services was driven by technical documentation for CE marking of IVD products related to COVID-19.
- SOFTWARE AS MEDICAL DEVICE (SAMD)
Over 30% of our regulatory affairs activities were related to SaMD, mainly development of technical documentation and clinical evaluations related to SaMD applications. We worked with a variety of SaMDs designed to carry out medical functions intended to diagnose or prevent Parkinson’s disease and rheumatoid arthritis, as well as treatment of atrial fibrillation disease.
- CE MARK APPROVALS IN EUROPE
We were involved in a number of CE mark studies of minimally invasive devices providing new treatment options for patients with heart valve disease. Out clinical and regulatory team also helped secure product approval of therapeutic medical devices providing lifesaving treatment options for patients suffering from COVID-19.
- CLINICAL PROJECT MANAGEMENT WORLDWIDE
We continued to establish ourselves as a key stakeholder in this area. Our clinical project management activities grew by 78% and we expanded our service offering to include clinical quality services and data management services.
The growth of our services in this area should continue powering our Company’s strength and sustainability throughout 2021 and beyond.
AKRN Scientific Consulting, S.L. is a privately owned life science consulting firm based in Madrid, Spain. We are committed to partnering with Medical Device companies developing innovative technologies to improve health care for more people and offer customized solutions crafted to each client’s needs. We combine therapeutic expertise and decades of industry know-how with excellent service and responsiveness to provide our customers with tailor-made solutions that can stand up to rigorous scientific and regulatory evaluations.
For general questions about the firm, please contact us at email@example.com.
To learn more about our amazing team and our services, please download our brief presentation or visit our Company’s website at www.akrnconsulting.com.