Regulatory Services

dossier

Regulatory Services

 

EC and RA (Ministry of Health) Submissions of the trials are performed and followed-up by Klinar CRO.

During EC submissions performed by Klinar CRO, the below procedures are followed:

EC submission package is prepared for sites and status reports are prepared including meeting dates, number of files requested, submission fees, requirements of ECs, etc. information.

Necessary documents (protocol, CRF, investigator brochure, etc.) are obtained from the sponsor company and the sponsor company is informed on a regular basis regarding the performed activities.

In addition, documents needed to be signed by the sponsor company are prepared for signature. As soon as site specific documents are prepared by Klinar CRO, EC files are also copied to gain time and submissions to the EC and MoH are performed at the same time. Upon request of the sponsor, the submissions are made by the CRAs personally.

Klinar CRO provides the following services after the submission: 

•Regular EC revisions, if any

•Tracking the approval letters of EC and MoH

•Mediation for the reviwal of the project files in the earliest MoH meeting

•The sponsor company is provided with all current information during the processes

•When all required approval letters are obtained, the copy of EC files including all the signed documents are forwarded to the sponsor company