Following the signing of the contract by the parties, establishing the study design, initiating the document preparation process by contacting the sponsor

     o Preparation of Clinical Study Protocol in accordance with Turkish Republic Ministry of Health Turkish Medicines and Medical Devices Agency, EMA/FDA legislations ve ICH requirements
     o Preparation of documents such as ICF (Inform Consent Form), CRF (Case Report Form).
     o Finalizing related documents by communicating with the sponsor and clinical center 

Insurance coverage for volunteers

At all stages, ensuring communication between the Sponsor, clinical center and monitor and informing the parties when necessary 

Preparation of submission files of Ethics committee and Turkish Republic Ministry of Health Turkish Medicines and Medical Devices Agency and following up the processes

Initiating the clinical trial following Ethics committee and Turkish Republic Ministry of Health Turkish Medicines and Medical Devices Agency approvals

     o Preparing the labels of products
     o Following determination of the clinical trial schedule, delivery of blood tubes and serum/plasma/biological material tubes to the clinical center 

Monitoring of the clinical trial or ensuring that it is monitored

Following up and execution of the process following the completion of the clinical phase

     o Submisson the necessary applications and notifications regarding the completion of the study
     o Transferring of biological samples from clinical center to Novagenix
     o Reporting of results following the bioanalytical process 

Following the completion of study, the Trial Master File of the project is archived.