Submission Experience Clinovo team members have an extensive knowledge of regulatory compliance and FDA SPIRA requirements, in all areas of clinical trials, including medical writing, biostatistics, clinical and statistical programming, and clinical data management.
A team with 5 to 16 years experience in FDA Submission Strong track record: NDA, BLA, IND, IDE, PMA and 510K. Experience with all types of companies, from small start-ups to market leaders. Experts in multiple therapeutic areas: Oncology, Antibiotics, Parkinson’s disease, Vaccines, Infectious diseases, Chronic Renal Failure, Rheumatology, Women’s health, HIV/AIDS, Cardiovascular, Pain/Neurology, Diabetes, etc. FDA advisory panel to expand the indication of its most extensively implanted and studied carotid stent of a major medical device company.
A comprehensive know-how in all aspects of clinical trials Integrated Summary of Safety (ISS) Integrated Summary of Efficacy (ISE) Tables, Listings and Figures (TLF) mockup development and coding ADS development and validation Electronic submission package Clinical Study Reports (CSR) written for Phases I through IV Protocol development
FDA Briefing Documents Preparation and on-site support for FDA advisory panel Risk management plans CDISC mapping and conversion Quality assurance for the Complete Response Letter (CRL) Patient Narratives
A unique expertise in FDA regulations Thorough, current knowledge of FDA guidelines and procedures Successful, direct interactions with FDA representatives FDA advisory panel meetings Dedicated and flexible teams able to meet tight deadlines
21 CFR PART 11 Compliance At Clinovo, we train our staff on the latest FDA regulations and implement all the technical controls required for 21 CFR Part 11 compliance. Our Computer System Validation (CSV) team also has in-depth experience in Software Engineering, Software Development Life Cycle (SDLC) and Validation.
CONTACT US Ale Gicqueau CEO & President ale.gicqueau@clinovo.com (408) 773-6250 www.clinovo.com