Clinical Affairs Management
Yakar Engineering offers a strategic combination of industry acumen, experience and medical technology expertise to deliver first rate clinical affairs management, from study design and protocol development through patient enrollment and clinical trial execution.
Boasting over 17 years in the medical technology arena, we possess contacts with senior opinion leader clinicians across a broad range of medical disciplines, making us ideally positioned to provide practical and definitive expert services, fully meeting the highest standards of quality & performance.
Our network of clinical experts provides a complete range of innovative, value-creating, and cutting-edge assistance to support clinical trials in the United States, European Union and the rest of the world, ensuring scientific integrity and compliance with applicable regulations and quality standards, such as: ICH-GCP, ISO 14155:2011, MEDDEV 2.7.1, MEDDEV 2.7/4, Medical Device Regulation, etc. in preparation of regulatory submissions.
Our wide range of clinical services includes, but is not limited to:
- Pre-Clinical and Clinical Trial Planning
- Clinical Investigation Protocol Development
- Identifying and Evaluating Study Locations
- Vetting & Selecting of Principal Investigator
- Compilation and Submission of IRB Application
- Patient Recruitment, Enrollment and Retention Execution
- Site Management and Site Monitoring
- Data Management & Bio-statistics
- Development of Clinical Evaluation Reports (CER)
- Post Market Clinical Follow-Up (PMCF) Coordination
- Clinical Summary Report Compilation
- Trial Master File (TMF) Compilation