Medical Device Studies

Medical device trials started with the regulations published in Turkey in recent years, Omega CRO completed nearly 20 medical device operation till 2015. In this field sponsors and researchers supported by writing medical article, designing studies, assisting medical device trials.

Study Design/Protocol Design

In order to show the effectiveness and safety of medical devices in the best way the protocol is prepared in accordance with local requirements and international guidelines for study design.

CRF and ICF Design/Adaptation

Data collection form (CRF) designed in compliance with the protocol and study purpose, informed consent form designed according to up-to-date guidelines.

Regulatory Submissions

The application file for Ethics Committee Dossier and the Ministry of Health Turkey Pharmaceuticals and Medical Devices Agency is prepared due to procedures and the process is carried up by Omega CRO.

Monitorization and Site Management

Monitorization services are carried out accordance with the study protocol and the data is gathered at the centre. Then the compliance of the data with GCP guidelines is checked. Apart from monitoriziation, information updates are done by contacting with the centers.

Site Management Organization

To support the researchers central support personnel assists them in medical device studies to maximize speed of the data collection process and the quality of the data. Also supporting patients at the site.

Data Management

Queries generated by the data management team, transmitted to the researchers eliminating the incoherence and increasing the quality of medical device studies.

Data Entry

Medical device study is carried out simultaneously with observational trials, so it is easy to advance to analysis stage at the end of the study. With an experienced data entry team fast and reliable data entry process is completed.

Statistical Analysis and Reporting

Omega CRO with an experienced statistics team, analysis of data collected through medical device studies are conducted in accordance with the purpose of the study.

Medical Writing Services

Final study reports, abstracts, posters and writing medical paper is done by an experienced medical writing team of Omega CRO.

Services | Medical Device Studies