Data Support

PRA's Early Development Services (EDS) data support team is co-located with our Phase I clinics, providing a full range of services from data collection through analysis and reporting. Our data support services can be rendered in conjunction with a clinical study or as stand-alone. Dedicated exclusively to early phase work, our team includes:

• Data Managers
• Programmers
• Biostatisticians
• Pharmacokineticists
• Medical Writers

Data Management

PRA's EDS data management team utilizes both paper and Electronic Data Capture (EDC) systems to deliver on time, high quality, final databases. In the clinics, we work with our EDC system utilizing Oracle Clinical RDC because of its "real time" client database access. Our data management team also works with multiple EDC systems based on client preference.

PRA's EDS data management group provides the following services:

• Case Report Form design/review
• Rapid database setup, development and testing of validation check programming
• Data entry
• Data validation, review and query resolution
• Efficient integration of all external data sources into the study database, including format specification, test transfers and reconciliation against CRF data
• Delivery of a final study database in a client specified structure, including CDISC-SDTM compliant SAS^® datasets (our default final structure). The average time from LPLV to database lock is two weeks.

Biostatistics, Pharmacokinetics, and Medical Writing

PRA has a large group of experienced biostatisticians, pharmacologists and medical writers in both the US and the Netherlands transforming data into information and knowledge. Our team performs data analysis services, including:

• Study design, protocol development, PK consultancy
• Randomization services, sample size calculations
• Statistical Analysis Plan development, including full Tables, Figures and Listings shells
• Interim study safety, dose escalation, or PK reporting
• Production of Tables, Figures and Listings using industry standards of software systems like SAS^® and WinNonlin^®, and adhering to internationally recognized coding standards such as CDISC
• Development of an Integrated Clinical Study Report (CSR), IDB/IMPD, statistical reports, and Pharmacokinetics/Pharmacodynamics reports

The average time from database lock to draft CSR is six weeks.

Our experienced EDS data support team normally works alongside the EDS project management team managing statistics, medical writing services and/or data management, but is able to provide "stand-alone" services apart from our clinics.