PPD’s clients can employ the technology, processes and expertise that best meet the needs of their project with PPD’s clinical data management solutions. Across a broad range of therapeutic areas and quantitative methods, PPD has extensive data management experience for Phase I-IV clinical trials.
Partner for Clinical Data Management Results
Our clients can expect:
- Global standards that ensure consistency of clinical data management
- Flexibility to meet their needs throughout project life cycles
- Quality management of data integrity
- Seamless software implementation with their systems and processes
- Specific technologies and best practices customized to their project
Our centralized, comprehensive clinical data management services group successfully processes more than 2 million case report form (CRF) pages on more than 170 protocols each year.
Quality Data, Leading Clinical Data Management Technologies
The integrity of clinical data is of paramount importance to a successful project. PPD ensures this integrity by strict adherence to established operating and review procedures throughout every stage of a project.
PPD works closely with clients to determine specific clinical technology requirements and then customizes software implementation to meet each client's unique clinical data storage and processing needs.
PPD delivers services in several widely accepted electronic data capture (EDC) environments including Medidata Rave®, Oracle® Clinical Remote Data Capture and Phase Forward InForm™. We also have standard “real-time” interfaces with core laboratory, imaging, and other vendors and ancillary systems to improve speed of data acquisition and review, thereby improving data quality and minimizing timeline risks.
Global Clinical Data Management Services
Located in multiple offices around the world, our clinical data management staff has the flexibility and expertise to meet local needs. To ensure consistency on a global basis, PPD data managers:
- Follow company-wide standard operating procedures (SOPs) and GCP/ICH guidelines
- Work closely with clients to define project needs
- Apply quality standards and processes to complete large and complex clinical programs successfully
Flexible, Sponsor-Focused Data Management Teams
PPD has multiple team formats designed to meet specific client needs, from a dedicated team in a functional service provider model to an integrated function in a full service team structure. Our commitment to a project includes:
- Efficient and cost-effective services of the highest quality
- A comprehensive and integrated package of services
- A team of experts dedicated to client success
- Close communication with clients through all phases of development and review of database specifications
Comprehensive Clinical Trial Data Management
Our clinical data management services include:
- Electronic case report form (eCRF) design, database design and study setup
- Integration with clients' existing systems and processes
- Clinical coding with industry standards and client-specific dictionaries
- Reconciliation of external data
- Data validation and query resolution
- Project management of data and technical services