- Development and Documentation of Clinical Research Strategy
- Preparation of Files for Submissionto Ethics Committee (EC) and Ministry of Health (MoH)
- Presentation of Ethics Committee Submissions and Addressing Related Questions
- Presentation of Clinical Research to Ministry of Health
- Project Management
- Preparation of Final Clinical StudyReport
Development and Documentation of Clinical Research Strategy: Den Clinical Research collaborates with medical device companies to develop robust and effective clinical research strategies. We help define the research objectives, study design, patient population, and endpoints based on regulatory requirements and industry best practices. Our team ensures that the strategy aligns with the specific goals of the medical device study.
Preparation of Files for Submission to Ethics Committee (EC) and Ministry of Health (MoH): We assist in preparing comprehensive documentation for submission to Ethics Committees and relevant regulatory bodies, such as the Ministry of Health. Our team ensures that all required documents, including study protocols, informed consent forms, investigator brochures, and safety reporting plans, are properly prepared and organized in accordance with regulatory guidelines.
Presentation of Ethics Committee Submissionand Addressing Related Questions: Den Clinical Research provides support during the presentation of Ethics Committee submisison. We assist in preparing presentation materials and address any questions or concerns raised by the committee members, ensuring a smooth review process.
Presentation of Clinical Research to Ministry of Health: Our team also supports the presentation of clinical research studies to the Ministry of Health. We prepare the necessary documentation and provide expertise during the presentation, addressing any inquiries or clarifications requested by the ministry regarding the study.
Project Management: Den Clinical Research offers comprehensive project management services for medical device clinical research. We ensure efficient coordination and execution of all project activities, including timelines, budgets and resource allocation. Our project management team works closely with stakeholders to ensure timely completion of milestones and deliverables.
Preparation of Final Clinical StudyReport: Den Clinical Research assists in the preparation of the final clinical studyreport. We ensure that the report accurately reflects the study findings, incorporates statistical analyses and meets regulatory requirements. Our team follows industry standards and guidelines to create a comprehensive and well-documented final report.
With Den Clinical Research's expertise in medical device clinical research management, you can rely on our comprehensive services to support the entire process, from strategy development to final report preparation. We ensure regulatory compliance, efficient project managementcontributing to the successful execution and documentation of medical device clinical research studies.