SUBMISSION TO ETHICS COMMITTEES AND COMPETENT AUTHORITIES

The preparation of applications to Ethics Committees (ECs) is a specialised regulatory task. For large multi-centre studies efficient completion of this step can make all the difference between meeting the projected timelines and being left behind.

At Pharmalys we have experienced staff dedicated to managing the ethics approval process.

Our in-depth knowledge of local and international regulatory requirements guarantees that regulatory approval processes are expertly managed by associates who have many years of experience in this area.

Our services include:

	Preparation of the submission dossier for EC's and competent authorities.
	Attendance of EC meetings together with the Chief Investigator
	Liaison with the competent authorities
	Support given to investigational sites for their local submissions
	Communication of approvals to your project team in a timely manner
	Periodic reporting required by ECs and the competent authorities on trial status and safety information