Donawa Lifescience Consulting (DLC), headquartered in Rome, Italy, has announced the opening of a wholly owned company in the US State of Massachusetts, Donawa Lifescience Inc., to promote its Clinical Research Organisation activities to both its existing and potential North American clients.
Donawa Lifescience Inc., together with DLC in Rome, are available to assist clients with clinical studies in the US, Canada and Europe. The newly appointed Director US Operations is Ana-Maria Panaitoiu, M.D., a physician with more than 20 years’ experience with drug, medical device and IVD investigational studies in multiple therapeutic areas in the US and Canada.
With the forthcoming transition to the European Medical Devices Regulation (MDR, 2017/745), even existing CE marked devices may require clinical studies to confirm their safety and clinical performance, with the need for Post-Market Clinical Follow-up (PMCF) studies expected to increase significantly.
DLC, working closely with Donawa Lifescience Inc., is particularly well-placed to help clients negotiate the clinical study and PMCF requirements of the MDR, and also assist with updating existing Clinical Evaluation Reports to meet increased Notified Body scrutiny and expectations.
The DLI office is located at 245 First St, Cambridge, Massachusetts 02142, and contact details are:
Ana Maria Panaitoiu, M.D., Director US Operations
Tel: +1 514 824 9101