Clinical Affairs Solutions
Accurate FDA Consultants will immediately supplement your organization by providing various clinical affairs solutions, including planning and executing clinical trials that will withstand the review and scrutiny of the authorities including the FDA and International Regulatory Authorities
We provide the following Clinical Affairs Services.
- Initial Research and Analysis
- Pre Clinical Discussions with FDA and the International
- Pre IDE/IDE/IND Meetings
- Clinical Strategies and Plans
- Clinical Trial Management Protocol Development
- Clinical Site selection
- IRB and Ethics Committee review
- Data Management and Monitoring, through closure.
- Statistical Services
- Site Training and Initiation
- Clinical Report and Review
Contact us today for a non-obligatory consultation and quote. Let’s discuss your needs and scope of your clinical affairs project and requirements.
- Enterprise Risk Strategy and Emerging Technologies to address critical needs
- 3D Printing Medical Device Manufacturing= Additive Manufacturing
- FDA Issues New Import Data Requirements
- Compliance Dates for UDI Regulatory Requirements
- Strategic and Effective FDA Pre-Submissions
- Addressing FDA Import Alert and “Notice of FDA Action”