Clinical Data Management & Biostatistics

Clinigene’s Clinical Data Management & Biostatistics (CDMB) team provides solutions that are customized to meet specific needs of our clients. Our systems, SOPs and project personnel are equipped to provide cost-effective and secure CDMB services efficiently. Our skilled project teams, which have studied and worked with the complexity of global regulatory requirements, have developed the expertise to deliver projects on time, with adherence to sponsor and protocol specific requirements.

Clinigene has a comprehensive disaster recovery plan designed to keep its extensive information system intact.

Expertise

CDMB services to support

• BA/BE studies
• Phase I-IV clinical trials
• Enabling EDC and eCRF

Services

Data Management:

• Case Report Forms (CRF) design
• Workflow management
• Data capture
  - Double data capture
  - Electronic data capture
• Discrepancy/query management
• Medical coding
• Serious Adverse Event reconciliation

Biostatistics:

• Statistical inputs for protocol design
• Sample size calculation
• Randomization/Blinding
• SAS coding
• Statistical analysis
• Statistical report preparation
• Support DSMB/DSRB conduct an interim analysis

Technical Infrastructure

• SAS PheedIt (21 CFR, Part 11) for data capture and   validation for EDC and paper based studies
• SAS Analytics for statistical analysis
• Adobe PageMaker for CRF designing
• MedDRA^® for Adverse Event coding
• WHO-DD for medication coding