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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 operations 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 options for data collection, cleaning, and reporting using the latest versions of industry leading 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.
Services
- CRF Design and Annotation (Conventional, CDASH, or SDTM Compliance)
- Protocol and CRF Review
- Internal EDC Capabilities using Oracle Clinical RDC Onsite
- CRF Scanning and Tracking Management
- Database Design, Validation, and Maintenance
- Lab Data Management and Conversions to Standard Units (Conventional or SI)
- Query Management
- Medical Coding
- SAE Reconciliation
- Real-Time Data Access/Browsing
- Standard and Custom Reporting
- Database Transfers (Conventional and SDTM formats)
- CDISC (SDTM) Dataset Conversions
- Generation of Define Documents (to describe either Conventional and SDTM) for Regulatory Reporting
- Independent Review/Validation of SDTM Datasets, SDTM Annotated CRFs, and DEFINE.XML Documents
- Complete Data Operations Support for NDA Submissions
Data Management Platforms
Premier Research has a long tradition of Oracle Clinical™ data management in the United States and Europe (an early adopter, first licensed in 1997). EDC, paper, and hybrid data collection designs are available.
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. We were the first company to complete an Oracle Clinical™ EDC study to regulatory standards.
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.
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 allows us to make recommendations on the most efficient and cost-effective approach for your study.
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