Starting a clinical trial involves making a submission to applicable competent authorities (CAs) and ethics committees (ECs) for written approval. The more efficiently and flawless this start-up process is carried out, the quicker we will receive approvals and countries and sites can be activated and patients be enrolled. ODC is familiar with the different regulations, agencies, practices and procedures in different countries of Europe, North America and Asia Pacific. Our regulatory team works in close collaboration with our clinical operations, consultancy, pharmacovigilance and our data management and statistics partners.

A list of some of the services we provide:

• Submission of the trial to regulatory authorities and ethics committees (including CTR in the EU)
• Continuous correspondence with regulatory authorities
• Answering queries and subsequent requests for information from authorities and ethics committees
• Regulatory document tracking, collection, review and filing
• Marketing authorization application (MAA)
• Orphan disease designation
• Scientific Advice

As SME (Small and Medium-sized Enterprise) we can offer you very favourable conditions for Scientific Advice, Marketing Authorization, and other EMA services.