Data Management
Employ the technology, processes and experts that best meet the needs of
your project with PPD’s 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 Results
When you partner with PPD, expect:
- Global standards that ensure consistency of data management
- Flexibility to meet your needs throughout project lifecycles
- Quality management of data integrity
- Seamless software implementation with your systems and processes
- Specific technologies and best practices customized to your project
Our centralized, comprehensive data management services group successfully
processes in excess of 2 million case report form (CRF) pages on more than 170
protocols each year.
The Quality Difference
The integrity of your data is paramount to a successful project. PPD assures
this integrity by strict adherence to established operating and review procedures
throughout every stage of a project. The data review process includes:
- Coordination of data managers, clinical personnel, programmers, statisticians
and your personnel
- Development of edit specifications and review guidelines
- Ongoing review and immediate feedback to support quality and efficiency
- Global consistency of deliverables
- Databases compatible with your requirements and systems
Leading Technologies
PPD will work with you closely to determine specific technology requirements
and then customize software implementation to meet your unique data storage and
processing needs.
- Expertise with global industry software standards, including Oracle
Clinical
- PPD QueryDirect , our proprietary query resolution
system
- A wide range of remote data collection techniques, including:
- Electronic data capture (EDC) systems
- Interactive voice response systems (IVRS)
- Fax-based data capture
Global Services
Located in multiple offices around the world, our 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 (SOP) and GCP/ICH guidelines
- Work closely with you to define your project’s needs
- Apply quality standards and processes to complete large and complex clinical
programs successfully
Flexible, Sponsor-Focused Teams
PPD utilizes a team approach, with a specified lead data manager centrally
designing and controlling project-specific databases. Our commitment to your
project includes:
- Efficient and cost-effective services of the highest quality
- A comprehensive and integrated package of services
- A team of experts dedicated to your success
- Close communication with you through all phases of development and review
of database specifications
Comprehensive Data Management:
Our services include:
- CRF design, tracking, entering and cleaning
- Database design and study setup using Oracle Clinical
- Remote data capture, including scanning, indexing and EDC
- Integration with your existing systems and processes
- Clinical coding with industry standards and client specific dictionaries
- Reconciliation of external data
- Data validation and query resolution using our proprietary PPD QueryDirect
- Project management of data and technical services
