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EUROPEAN CLINICAL STUDIES

• Are you preparing for European clinical studies?
• Concerned about selecting the right investigators and sites?
• Unsure about study costs and local requirements?
• Need to obtain rapid approval to start the study?
• Wish to use the study data for US submissions?

Donawa Lifescience Consulting (DLC) can help your company to successfully plan and complete European clinical studies to assess safety in compliance with applicable laws, standards and Good Clinical Practice requirements.

DLC is a full service European clinical research organization (CRO) specializing in life science technologies, including pharmaceuticals, medical devices, drug-device combination products and human tissue based products. We have extensive experience in both US and European requirements. As such, DLC provides the reassurance that regulatory and local study-related needs are understood and appropriately managed, and that actions can be taken to prevent costly duplication of studies for US approvals and clearances. Thanks to a network of local clinical research associates (CRAs), DLC manages clinical studies across Europe and beyond. Our CRAs have full access to our team of medical or regulatory affairs experts throughout the project, so that any study-related issue can be addressed in a timely and effective manner.

Click here to download our 'Five Tips to Keep in Mind in Your European Clinical Study' factsheet.

Clinical studies are managed from the DLC Rome office. Contact us either by e-mail for a confidential discussion about your project, or speak to Daniela Karrer, Director, Clinica Affairs EU/US, on +39 06 578 2665.