MEdical Devices Studıes

Transforming Medical Device Trials with Comprehensive Services

overview

Leading the Way in Medical Device Trials

Omega CRO is at the forefront of medical device trials in Turkey, with a history of successfully completing nearly 50 projects by 2015. Our comprehensive services cover every aspect of medical device studies, from study design and protocol development to regulatory submissions and data management. By adhering to local requirements and international guidelines, Omega CRO ensures the highest standards of efficacy and safety in medical device trials. Our expert team provides unparalleled support to sponsors and researchers, assisting in the design, execution, and management of studies to maximize the quality and speed of data collection.

Turkey offers a strategic advantage for conducting first-in-human trials due to its well-established regulatory framework, experienced investigators, and cost-effective site operations. This ensures expedited initiation and completion of clinical trials, making Turkey an attractive destination for early-phase medical device studies.

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SOLUTIONS

Omega CRO stands out with our dedication to quality, innovation, and comprehensive support. From navigating complex regulations to pioneering patient-centered approaches, we are your trusted partner in advancing medical device research. Experience the difference with Omega CRO—where efficiency meets excellence.

Study Design and Regulatory Services

Omega CRO excels in crafting meticulously designed studies and protocols that align with both local and international guidelines. Our expertise in regulatory submissions ensures seamless approval processes, minimizing delays and risks. Additionally, our proprietary randomization software guarantees unbiased participant allocation, enhancing the validity and reliability of clinical trial results.

Monitorization and Site Management

Our comprehensive monitorization and site management services ensure rigorous compliance with GCP guidelines. Omega CRO maintains continuous communication with study centers, providing regular updates and addressing any issues promptly. The implementation of sham devices in trials allows for reliable control groups, facilitating accurate assessment of medical device effectiveness.

Data Management, Statistics, and Medical Writing

Omega CRO ensures high-quality data collection, analysis, and reporting. Our team collaborates with researchers to eliminate inconsistencies and enhance data quality. Comprehensive statistical analyses provide insights that drive informed decision-making. Additionally, our Clinical Study Report (CSR) and medical writing services deliver regulatory-compliant documentation, accurately reflecting study outcomes.

Logistics and Compliance Support

Omega CRO offers robust logistical support, including secure import, storage, and distribution of medical devices through our dedicated depot. Our certified processes for the destruction of used materials comply with stringent safety and environmental protocols. Additionally, we prioritize the perspectives of lay persons and patients, ensuring that devices are user-friendly, safe, and effective in real-world settings.

Precision in Protocol, Excellence in Execution.

Omega CRO is committed to maintaining the highest standards of quality management in accordance with
ISO 13485. This internationally recognized standard outlines the requirements for a quality management system specific to the medical devices industry, ensuring that devices consistently meet customer and regulatory requirements.

Study Design/Protocol Design

We develop robust study and protocol designs to showcase the effectiveness and safety of your medical devices, adhering to both local and international guidelines.

Regulatory Submissions

Our team meticulously prepares and manages application files for Ethics Committee Dossiers and the Ministry of Health Turkey Pharmaceuticals and Medical Devices Agency, ensuring full compliance and expedited approvals.

Monitorization Services

Conducting thorough monitorization services ensures compliance with study protocols and GCP guidelines. We gather and verify data at centers, providing continuous updates through center contacts.

Data Management and Statistics

Our data management services ensure high-quality data collection and analysis. We work closely with researchers to generate queries, eliminate inconsistencies, and deliver reliable study outcomes.

CSR and Medical Writing

Our Clinical Study Report (CSR) and medical writing services deliver comprehensive, regulatory-compliant documentation that accurately reflects study outcomes and supports regulatory submissions.

Medical Device Import/Storage and Distribution

Omega CRO offers secure import, storage, and distribution services for medical devices, including a dedicated depot for safe storage, ensuring timely and reliable delivery to trial sites.

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Experience the difference with Omega CRO—where efficiency meets excellence.

Study Design/Protocol Design: 

Omega CRO excels in creating meticulously crafted study designs and protocols to demonstrate the effectiveness and safety of medical devices. Our protocols are prepared in compliance with both local requirements and international guidelines, ensuring that the studies meet the highest standards of scientific and ethical rigor. Each protocol is tailored to the specific objectives and scope of the study, providing a clear roadmap for successful trial execution.

Our expertise extends to the meticulous planning of every aspect of the study, including patient selection criteria, intervention methods, and outcome measures. By focusing on these critical elements, we ensure that the study design robustly supports the intended research objectives. This comprehensive approach enhances the credibility and reliability of the study results.

Furthermore, Omega CRO collaborates closely with sponsors and researchers throughout the design phase, offering expert guidance and support. This collaborative approach fosters a deep understanding of the study goals and ensures that all stakeholders are aligned. Our commitment to excellence in study design sets the foundation for successful and impactful medical device trials

Solutıons

Regulatory Submissions

Navigating the complex landscape of regulatory submissions is a core strength of Omega CRO. Our team meticulously prepares application files for Ethics Committee Dossier and the Ministry of Health Turkey Pharmaceuticals and Medical Devices Agency. We ensure that each submission is fully compliant with the required procedures and regulations, minimizing the risk of delays and rejections.

The submission process involves the careful compilation and presentation of all necessary documentation, including study protocols, informed consent forms, and safety data. Our expertise in regulatory requirements ensures that all submissions are thorough and precise, addressing any potential concerns from regulatory bodies.

We also manage the entire submission process, coordinating with regulatory authorities and providing timely updates to sponsors and researchers. This proactive approach ensures that all regulatory requirements are met efficiently, allowing the study to proceed without unnecessary interruptions. Omega CRO’s regulatory submission services provide a seamless pathway to trial approval, ensuring that your medical device studies can commence promptly.

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Monitorization and Site Management

Omega CRO offers comprehensive monitorization and site management services to ensure the integrity and compliance of medical device studies. Our monitorization services are conducted in strict accordance with the study protocol, with data gathered at the center and thoroughly checked for compliance with GCP guidelines. This rigorous approach ensures that all data collected is accurate and reliable.

In addition to monitorization, we maintain continuous communication with study centers, providing regular updates and addressing any issues that arise. This ongoing contact helps to streamline the study process and ensure that all centers are aligned with the study objectives and protocols.

Our site management organization goes beyond monitorization, offering central support personnel to assist researchers in maximizing the speed and quality of data collection. We also provide support to patients at the site, ensuring that they receive the care and information they need throughout the study. Omega CRO’s monitorization and site management services are designed to enhance the efficiency and success of your medical device trials.