Clinical Study Submission
A key element for a Clinical Study progress is the regulatory path necessary to obtain all the mandatory approvals. All the information must be prepared in the correct way and submitted to all the legal entities (Competent Authorities, Ethical Committee, IRB, etc.).
Official communications must be shared for the entire duration of the study in order to officially inform the stakeholder and authorities in relation to device change, protocol amendment, study progress, Adverse Events.
Merc is able to support you in these activities, developing the appropriate documentation and answering the questions that the authorities may rise.