Report Writing
KnowTechInfo staff are experts in the regulatory data sciences surrounding data standards and compliance with FDA mandated standards for submissions. The United States FDA now requires standardized data to be submitted with NDAs, BLA, and ANDA’s. We develop and provide our clients high quality:
Full Clinical Study Reports (CSR)
Study protocols and amendments
Statistical sections of CSRs, in collaboration with sponsor medical writers
Statistical Reports
In addition to study specific report writing our team supports clients with integrated statistical and writing services to support:
