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.
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- 2020 Over-the-Counter (OTC) Drug Monographs Reform Summary
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- FDA Issues Emergency Use Authorization (EUA) for Face Masks/Respirators to Expedite Importation into U.S
- How to fight the coronavirus SARS-CoV-2 and its disease, COVID-19 – Michael Lin, PhD-MD
- CBD – To Be or Not to Be a Drug? Predicting the Impending FDA Regulations on Cannabis.