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Data Management
Effective data management services facilitate efficient access, processing, summarization, and dissemination of data and information. TRS's data management services incorporate leading edge technology, 21 CFR Part 11 compliant systems, and experienced clinical data management personnel to support both electronic clinical data management (eCDM) and traditional Case Report Form (CRF) double entry applications.
Our data management services are scalable to your needs and performed with an emphasis on well-organized, appropriately documented, accurate, and timely processing of your clinical data.
Our systems are designed to facilitate rapid restoration of data in the unfortunate event of server failure. TRS's paper CRF data processing servers are located in a secure, environmentally controlled area within our corporate facility and backed up real-time at an off-site facility. Our eCDM servers are located at a state-of-the-art remote web hosting facility. Both remote facilities utilize standard best practices with respect to data security.
Our Data Management services include:
Data management plan
- Development
- Maintenance
- Bi-annual review
- Version controlled documentation
EDC/Paper CRF/OCR/IVRS data capture
CRF design
- Form design
- Database design, validation and user acceptance test, Database updates
- Automated accuracy/logic checks of entered data
Data verification (data entry discrepancy resolution), CRF status tracking and inventory
Data validation, Automated/manual query generation/tracking
Data coding (MedDRA, etc.)
Database cleaning and lock procedures, data transfer procedure
Data exports in commonly used formats
Data quality assurance and quality control
Standard/customized reports
Review of final data listings, final data tables or graphs, final reports
Communication of data trends
Our Biostatistics services include statistical consultation and programming support at every stage of a study:
Pre-study
- Input on clinical study design / protocol development
- Sample size and power analysis
- Randomization schedule development
- CRF design and review
During the study
- Consultation on statistical methodology
- Comprehensive statistical analysis plan development
- Customized data listings for safety reviews, medical monitors or data cleaning processes
After study completion
- Formatted statistical tables, listings and figures
- Statistical report/summary preparation
- Review and interpretation of statistical results for the clinical study report
- Ad-hoc exploratory analyses
PMI’s Quality Control procedures for statistical output involve a combination of independent programming and internal review to provide accuracy of the results.
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