Kuantum CRO

Clinical Research Services

1- Selection of site and investigators

2- Initiation, monitorization and close out of study sites

3- Progress reporting

4- Safety reporting and monitoring

5- Follow-up of EC and RA reporting

6- Design and production of study newsletters

7- CRA and Investigator training

8- Investigators' meeting organization

9- Financial agreement preparation for the investigators and institutions

Medical Services

1- Case Report Form (CRF) design

2- Informed Consent Form (ICF) writing

3- Investigator's Brochure writing

4- Medical translation and translation control

Regulatory Affairs Services

1- EC and RA applications (index and timelines)

2- IL application (index and timelines)

3- Regulatory Body negotiations

4- Preparation of revisions in collaboration with clients

Regulatory Affairs Regulations