The submission of clinical study applications to regulatory authories, where required, and requests for approval from Ethics Committees/IRBs, are extremely important tasks in the clinical study process. Clinical study projects can be unnecessarily delayed if these activities are not conducted with care and a thorough knowledge of regulatory and Ethics Committee/IRB requirements.
DLC has dedicated clinical teams, organized into two ‘units’, expert in achieving clinical study approval by regulatory authorities and the execution of site agreements, which are needed to begin enrolment at clinical sites.
The Clinical Regulatory Unit is responsible for:
- Submissions of medical device and IVD study documents to Ethics Committees and, in the United States (US), Institutional Review Boards (IRBs)
- Submissions of medical device and IVD study documents to European Competent Authorities and the US Food and Drug Administration.
The Site Agreement Unit is responsible for:
- Negotiation and execution of sponsor agreements with clinical sites in Europe, US and Canada
- Management of invoices from and payments to clinical sites
The DLC Clinical Study services are 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.