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 project teams are equipped to provide cost-effective, secure, and efficient CDMB services. Having studied and worked with the complexity of global regulatory requirements, our skilled project teams have developed the expertise to deliver clinical projects on time, with adherence to sponsor specific requirements.

Expertise

- CDMB services to support Phase I-IV clinical trials
- BA/BE studies

Services

Data Management

- Case Report Forms (CRF) design
- Workflow management
- Data capture
   - EDC
   - Paper CRFs
- Query management
- Discrepancy 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

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