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 20 years, helping clients to develop regulatory strategies and conduct clinical studies in Europe and the US, and if needed, 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.
CLINICAL STUDIES WITH IN VITRO DIAGNOSTICS (IVDs)
IVD clinical studies have very different aspects from other medical devices and DLC understands these differences. DLC has extensive experience in designing, planning and managing clinical 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. The combined efforts of in-house regulatory IVD experts and clinical experts allows DLC to also offer support in defining regulatory strategies during ongoing product development.
CLINICAL STUDIES IN ITALY WITH MEDICINAL PRODUCTS (ITALIAN MINISTERIAL DECREE 15 NOV 2011)
Where a medical device study in Italy involves a medicinal product, which may be a comparator or part of a drug-device combination product, in accordance with the requirements of Italian Ministerial Decree of 15 November 2011 (“CRO Decree”), DLC provides the following services: study planning, protocol writing, site selection and activation, preparation of study submissions to Ethics Committees and Competent Authorities; management and archiving of clinical study documents, monitoring and final report writing. DLC does not offer any service in relation to Phase I studies.
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.