As part of the CE marking process for Calmark's product, pilot studies will be conducted on new-born infants in Sweden. After the CE marking has been obtained, more extensive clinical studies will be conducted in several countries. Calmark Sweden AB has therefore signed an agreement today with Scandinavian CRO (SCRO), headquartered in Uppsala. The agreement covers the provision of consulting services in the planning and execution of said studies, for instance assistance with administration and monitoring.
Scandinavian CRO specializes in medical technology products, and has more than 10 years of experience in the industry. The company is a full-service CRO, which means that it offers the entire chain of services, from the planning of clinical studies and the seeking of ethics approval, to practical implementation of studies and writing of reports. SCRO is the fastest-growing CRO in Scandinavia.
"We are looking forward to initiate work on the clinical studies of our products. Even though Calmark has a solid in-house expertise in clinical studies management, this is a hectic time for the company. In advance of the forthcoming clinical studies we have therefore chosen to enlist assistance, in particular with the administrative work. SCRO has an impressing track-record and long experience, and will be able to relieve our workload so that we can proceed more quickly. We are looking forward to getting down to work, together", says Anna Söderlund, CEO of Calmark.