Technical Resources International, Inc. (TRI) provides data management and statistical analysis services for all phases of clinical research as well as for toxicology and research program management. More than a decade of continuous improvement and investment in automation allows us to offer the quality, speed, and cost that your project requires, regardless of its size or complexity.
- Clinical Data Management
Our Data Managers and EDC Builders have extensive experience with multiple Electronic Data Capture (EDC) products, including Oracle Clinical RDC (hosted at our data center), Rave, and agCapture, which allows us to select the best one for your study. We have integrated those systems with data visualization and business intelligence tools (Jaspersoft, SAS Visual Analytics, Pentaho) to give our clients the ability to view and analyze their study data in combination with operational metrics from other systems, e.g., site activation timelines, CRA-reported deviations, safety signals and QA findings. These technologies, combined with our rigorous use of CDISC data standards, result in high-quality, cost-effective, and fast turnaround services for database development, data acquisition, and database lock.
Our Clinical Data Management Department has completed a wide range of drug and device trials, including small (e.g., 16-subject, phase 1, drug abuse) to large (8,000-subject, phase 3, assisted fertility) trials. In all our projects we rely on:
- An extensive library of data collection tools
- Electronic Data Capture (Oracle Clinical RDC, OpenClinca, Medidata Rave), with special emphasis on user training
- Integration with Safety Systems, EHR/EMR Systems, laboratories, and central readers
- Automated randomization
- Automated enrollment and data quality reports
- Integration with mobile devices for collection of PRO data
- Expert MedDRA, CTCAE, ICD-9/10, SNOMED, and WHO Drug coding
- Extensive implementation of automated data discrepancy checks
- Systems and personnel to support central site monitoring
- 21 CFR Part 11 compliance and ISO-certified information security system
- Biostatistics and Statistical Programming
Crucial to the success of a product development plan is appropriate clinical trial design. Our statisticians and regulatory strategists provide expert advice to our clients to ensure that adequate outcomes are measured and that studies are adequately powered. We have expertise in adaptive designs and Bayesian statistics which, when applied appropriately, can shorten timelines and reduce costs. By working closely with Data Management and Clinical Operations, our Statistical Programmers routinely produce final analyses within a week of database lock. TRI is adept at determining the most suitable experimental designs and analytic approaches that will focus on the outcomes and endpoints essential to the sponsor’s objectives.
- Program Management Database Support
In addition to clinical data, we support large clinical research programs by collecting, analyzing, and reporting study metadata. This service gives our clients a cross-study view of the status of their program, allowing them to make better portfolio management decisions. We also use these data to comply with clinical trial registration and results disclosure regulations.