Premier Research: Data Management


	Data Management

Statistics

Medical Writing

IVRS

Regulatory Affairs

Quality Assurance

Strategic Product Development

The generation of a clean, scientific database in preparation for statistical analysis and compliant with regulatory guidelines is one of the most important aspects of clinical research. Premier Research’s data management group can help you achieve your study goals by navigating your drug through the development lifecycle quickly and efficiently, providing you with clean scientific data. Premier Research offers a range of options for data collection and use of the latest versions of industry-standard software.

Maximizing Efficiencies

Premier Research utilizes the Parallel Processing Approach™ (PPA). PPA has been established in-house for a number of years and successfully implements cost-effective high quality, rapid execution of biometrics study tasks.

Accurate, Secure Data

All of our sponsors can be confident that the databases we create for them will be of unassailable regulatory quality through the use of well-defined and continuously enhanced processes and technologies. We carefully select and train our team to ensure that the end product is fully compliant with regulatory guidelines and meets the stringent criteria demanded by our Standard Operating Procedures.

Employing PPA with built-in specifications of 0.0% errors for critical fields and <0.05% for all other fields, Premier Research databases invariably pass QC review.

Premier Research has state-of-the-art security, back-up and disaster recovery systems in place to ensure confidence that all data remains confidential and safe.

Flexible Data Solutions

We offer flexibility in data management solutions while always maintaining our exacting standards for data quality and timeliness. In addition to full-service studies, we undertake many stand alone and functionally based biometrics projects. Clients rely exclusively on our staff to manage all biometrics aspects from rapid data entry to final study reports. Our experience with multiple data management platforms allows us to make recommendations on the most efficient and cost-effective approach for your study. We offer paper-based as well as EDC solutions.

Data Management Platforms

Paper-Based Data Collection
Premier Research has a long tradition of Oracle Clinical™ data management in Europe (an early adopter, first licensed in 1997) and in the United States. We have also continued to build our paper-based expertise in the United States in another Oracle based environment combined with the PPA management of biometrics deliverables.

Electronic Data Capture
Premier Research employs a validated, 21 CFR part 11 compliant EDC solution (Oracle Clinical Remote Data Capture) that is capable of handling small, single site Phase 1 trials as well as multinational, multilingual Phase 3 and 4 trials. Coupled with the extensive Oracle Clinical experience from a large support of data managers, database developers, and programmers, Premier Research is poised to host any EDC trial within your clinical program. We are an ideal provider for EDC hosting, support, and biometrics management due to our extensive experience with our in-house EDC system as well as with several EDC partners and sponsor proprietary systems. In addition, Premier Research was the first company to complete an Oracle Clinical™ EDC study to regulatory standards.