Biostatistics and Programming
- Company Data Standard Development
- SDTM Submission Package
- ADaM Submission Package
- TFL, Patient Profile
- ISS/ISE, Interim Analysis, Submission
- Data Warehousing
- Data Review and Visualization
EDETEK’s services include clinical data management, biostatistics, programming, data standardization, enterprise standard development, clinical informatics, and computational environment hosting. We participated in more than fifteen submissions to regulatory agencies (e.g., FDA, PMDA, EMA, Health Canada) in the last two years across various therapeutic areas including Oncology, CNS, Cardiovascular, Vaccine, Infectious Disease, Immunology, Dermatology, Ophthalmology, Pain, Rare Disease, and Gene Therapy, to name a few.
Our biostats and statistical programming activities include SDTM, ADaM, TLF, IB/DSUR/DMC, FDA Briefing Book, Publication Support, BIMO, Patient Profile, Patient Narratives, Data Review List, PDF Listing and Smart Listing. In addition, we perform data masking, data scrambling for blinded studies, as well as de-identification/anonymization based on special regulatory requirements. Our clinical data management activities include CRF design, clinical database build, data management and review, medical coding, SAE reconciliation and database lock.
