AKRN Scientific Consulting
AKRN Scientific Consulting is a life science consulting firm specialized in strategic development and management of clinical trials for the medical device industry. AKRN is based in Spain and Sweden.
We provide clinical development services on a stand-alone basis, or as part of an integrated full-service solution together with our European CRO-partners.
Our clients include MedTech start-up companies as well as multi-national companies.
We are committed to partner with Medical Device companies developing innovative technologies improving health care for more people.
We are highly qualified, experienced, and accountable clinical research professionals that guarantee cost-effective and successful solutions crafted to each client’s needs. We and combine therapeutic expertise and decades of industry know-how with excellent service and responsiveness to support our customers with solutions that can stand up to rigorous scientific and regulatory evaluations.
We follow the national and international current standards (ICH/GCP guidelines, European regulations, and national and regional legislation), and the client or AKRN internal SOPs.
– Clinical Trial Services
– Clinical Evaluation Reports CER
– PMS, PMCF and PSUR
– EU Regulatory strategy and Support
– MDD to MDR transition for Class I, II and III