Donawa Lifescience Consulting (DLC) is a leading full-service Contract Research Organization (CRO), specialized in medical devices, in-vitro diagnostics, and drug-device combination products. We have been operating for over 25 years, helping clients to develop regulatory strategies and conduct clinical studies in Europe and the US, and if needed, manage US and European regulatory issues that may arise.
DLC provides expert support in all phases of a clinical study including protocol development, site selection, regulatory submissions, site monitoring, data management, statistical analysis and medical writing.
CLINICAL STUDIES WITH MEDICAL DEVICES
DLC clinical study personnel are expert in the unique aspects of medical device clinical studies, specializing in studies intended to generate data needed for US submissions and CE marking. DLC-managed studies range from the extremely complex to the relatively straightforward with devices that range from very high risk (e.g., vascular surgery and interventional cardiology), to medium and lower risk devices, and devices that vary over a wide range of therapeutic areas.
In working with DLC, you will also have the distinct advantage having access, if needed, to DLC staff who are recognized experts in US and European device requirements. This means that if a regulatory issue arises, we are available to assist you.
PERFORMANCE STUDIES WITH IN VITRO DIAGNOSTICS (IVDs)
IVD performance studies differ significantly from medical device investigations. DLC has extensive experience in designing, planning and managing clinical performance studies with IVDs for US and European market access. DLC’s expertise spans a large variety of technologies, including DNA based devices, in a number of diagnostic indications, among which are cancer, coagulation and infectious diseases. By combining the skills of in-house regulatory IVD experts and clinical experts, DLC provides strategic regulatory support throughout the product development process.
The DLC European CRO service is managed from our headquarters in the historical centre of Rome, Italy. Contact us either by e-mail for a confidential discussion about your project, or call Daniela Karrer, VP Operations and Clinical Affairs, on +39 06 578 2665.
