ClinChoice’s in-house medical writers have diverse experience and proven competency in preparing high-quality reports critical to clinical trial progression. ClinChoice’s ISO 13485 certification is a testimony to our medical writing staff’s knowledge of the quality standards necessary for medical devices. Our understanding of the US FDA clinical investigation regulations, MDR 2017/745 and IVDR 2017/746 regulations, GCP guidelines, and relevant international standards is key to authoring highly accomplished reports.
Medical Devices & Diagnostics
Clinical Development Services
Our medical and technical writers contribute to the monitoring and analysis of medical devices and IVDs throughout the entire product lifecycle.
- Clinical Investigation Plan (CIP)
- Clinical investigation report (CIR)
- Clinical Evaluation Plan (CEP)
- Clinical Evaluation Report (CER)
- Investigator Brochure (IB) development
- Instructions for Use (IFU)
- Risk-benefit Assessment
- IDE Submissions
- Performance Evaluation Plans (PEP)
- Performance Evaluation Reports (PER)
Literature Monitoring
ClinChoice’s literature search specialists apply industry best practices to perform global and local searches that identify precise and complete safety and performance information from a comprehensive array of literature sources for incident reporting, technical and medical writing, and trend reporting. We provide end-to-end services for Systematic Literature Review:
- Search strategy creation
- Inclusion and exclusion criteria development
- Shortlisted article management
- Local and global literature monitoring
- Analytical summary writing
- Literature protocol and reporting