Clinical Data Management Services

PPDs clients can employ the technology, processes and expertise that best meet the needs of their project with
PPDs 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 technologyrequirements 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