Data Management & Biostats

IRL Research strives to provide comprehensive & high quality clinical data management services to Pharmaceutical industries. Our Data Managers play a key role in each trial right from designing the Case Report Form (CRF) to providing input on key project documents

Our services include:

• Protocol design
• Review & input on protocol design
• CRF design & review
• Database design compliant with 21 CFR Part 11 according to client’s specifications
• SOPs and Guidelines
• Independent data entry of hard copy CRFs
• Electronic tracking of CRFs and Data Queries
• Thorough data review using validated electronic checks, data listings, and manual checks
• Coding according to standard coding conventions, as specified by the sponsor
• Maintenance of Logs, MIS, Tracking Spreadsheets
• QA/QC
• Data Analysis, lock  & submission

Biostatistics

Services offered include:

• Data collection
• Study design
• Sample size determination
• Statistical analysis
• Interpretation of results
• FDA submissions
• Publication support