Services | Clinical Trials

Clinical Trials

Omega CRO has experience in Phase II, Phase III and Phase IV trials in almost all therapeutic areas. Supports at every stage, as designing, analysing and monitoring clinical trials as well as storage of study material.

Study Design/Protocol Design

The protocol prepared according to local requirements and international guidelines to carry out the study in the best possible way.

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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.

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Ethics Committee Dossier and MoH Dossier Preparation

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.
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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.

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Site Management Organization

To support the researchers central support worker (groundman) assists them in clinical trials to maximize speed of the data collection process and the quality of the data. Also supporting patients at the site.

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Data Management

Data management in clinical trials is critical for the quality of the work. Queries generated by the data management team, transmitted to the researchers eliminating the incoherence and increasing the quality of clinical trials.

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Data Entry

Data entry is carried out simultaneously with clinical 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.
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Statistical Analysis and Reporting

Omega CRO with an experienced statistics team, analysis of data collected through clinical trials are conducted in accordance with the purpose of the study.
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Medical Writing Services

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

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