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EDETEK Services:
High Quality Delivery is
our #1 Priority

EDETEK has a proven engagement model comprised of a dedicated global services team possessing deep industry knowledge with hundreds of years of combined experience

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

Data Management

• Query Management
• Study Supply Reconciliation
• External Data Loading and Reconciliation
• SAE Reconciliation
• Dictionary Coding (MedDRA and WHO Drug)
• Data Base Lock

Study Development

• Clinical Development Plan
• Protocol Development
• Site Documentation
• Statistical Analysis Plan (SAP)
• Data Management Plan (DMP)
• Randomization Schedule

Medical Writing

• ICH Compliant and Abbreviated Clinical Study Reports
• Statistical Summaries
• SAE Narratives
• ISS/ISE Data Packages
• electronic Common Technical Document

eClinical Operation

• EDC Start Up and Conduct Support
• Fast Protocol Amendment Support
• CRF Design & Database Setup
• eTMF Configuration and Support
• IWRS and CTMS Setup
• Randomization and Trial Supply Management
• AE/SAE Recording/Reporting
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 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.