Data Management and Biostatistics

With experience in a broad range of Phase I clinical trial designs, PPD’s experienced and dedicated data management and biostatistics staffs provide comprehensive services.

Data Management

Our 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 Acceliant eClinical Suite clinical data and trial management platform
• Data edit programming – Acceliant and SAS software capabilities
• Dual interactive data entry
• Data validation and query resolution
• Medical coding with Medical Dictionary for Regulatory Activities (MedDRA) and other dictionaries, including WHO-Adverse Reaction Terminology (WHO-ART), WHO-DRUG, Coding Symbols for Thesaurus of Adverse Reaction Terms (COSTART) and client custom dictionaries
• Random sample and critical variable quality control data review with a 0.1 percent acceptable error rate.
• Database mapping to meet your specific needs, including Clinical Data Interchange Standards Consortium (CDISC) study data tabulation model (STDM) submission standard SAS datasets

We work closely with your personnel to develop detailed specifications for collection, processing and cleaning of data and a formal quality control plan.

Biostatistics

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 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