Clinical Data Management & Biostatistics
Clinigene provides Clinical Data Management & Biostatistics (CDMB) solutions that are customized to meet specific needs of the sponsor. Our systems, SOPs and personnel are equipped to provide cost-effective, secure, regulatory-compliant and efficient CDMB services. Our professional teams are experienced in handling multiple studies in all four phases (Phase I-IV).
Having studied and worked with the complexity of global regulatory requirements, we have developed the expertise to deliver clinical projects on time, with adherence to sponsor specific requirements.
Expertise
- Project management
- CDMB support to all phases of Clinical trial
Services
Data Management
- Workflow management
- Case Report Forms (CRF) design
- Data capture
- Query management
- Medical coding (WHO-DD & MedDRA)
- Serious Adverse Event reconciliation
Biostatistics
- Statistical inputs for protocol design
- Sample size calculation
- Randomization
- SAS coding
- Statistical analysis
- Statistical report preparation (Phase I-IV and BA/BE studies)
Technical Infrastructure
- SAS PheedIt (21 CRF Part 11) for data capture and validation for EDC and paper based studies
- SAS for statistical analysis
- Adobe PageMaker for CRF designing
- MedDRA for Adverse Event coding
- WHO-DD for medical coding
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