Clinical Data Management and Biostatistics
With experience in a broad range of Phase I clinical trial designs, PPD’s experienced and dedicated clinical data management and biostatistics staffs provide comprehensive services.
Clinical Data Management
Our clinical data management team works closely with PPD’s Phase I clinic to provide quality and timeline-conscious setup of databases, integration of data sources and cleanup of data. We also provide these same services for studies run at clinical sites of your choice. Our services include:
- Case report form design
- Rapid database design and study setup using Oracle Clinical Remote Data Capture (OC RDC) clinical data and trial management platform
- Data edit programming using OC RDC and SAS
software capabilities - Data validation and query resolution
- Clinical coding with industry standards and client-specific dictionaries
- Database mapping to meet your specific needs, including Clinical Data Interchange Standards Consortium (CDISC), study data tabulation model (STDM) submission and standard SAS datasets
Our dedicated and flexible Phase I team works closely with your personnel to develop detailed specifications for processing and cleaning clinical data.
Biostatistics Services for Clinical Trials
Our statistical scientists perform quantitative analyses and report on clinical trials in a broad range of Phase I trial designs. Team leaders heading well-trained statistical groups ensure accurate statistical planning and analysis, reporting and documentation, and delivery of high-quality output.
Our biostatistical services include:
- Consultation on design of studies
- Protocol design
- Sample size calculations
- Randomization services
- Statistical analysis plan development
- Analysis file creation
- Table, listing and figure production
- Interim analyses
- Data safety monitoring board participation and deliverables
- Statistical reports
- Collaboration on integrated clinical statistical reports
- Preparation of electronic submission ready datasets
