Technical Approach
CRS provides CDM support for diverse data requirements, varied patient populations, and standardized research methods, while ensuring compliance with the complex and ever-evolving regulatory requirements.
Our technical approach provides the flexibility to meet the specialized needs of each individual study team of the Customer while implementing uniform practices; manage Standard Operating Procedures (SOPs) that align with Customer goals and measures; and ensure work products consistent with Good Clinical Data Management Practices (GCDMPs).
Our CDM track record includes:
- elimination of data backlog inherited from previous vendors;
- 100% timely data submissions;
- 99% quality of data consistency (higher than industry standards);
- consistently high CPARS ratings for management and quality; and
- rated top 5 for data management quality by CIBMTR
Tools
Our Team has extensive experience with multiple clinical research databases and other tools, including:
- Cancer Central Clinical Database (C3D) (Oracle Clinical Database utilized at CCR)
- iMedidata Rave
- Labmatrix
- Clinical Trial Database
- REDCap
- InForm
- Ocore
- Progeny
- Trial Master
- eCaseLink
- FormsNet
- JReview
QC Methodology
Our Quality Control system is based upon our QMS — Plan, Do, Check, Act (PDCA) methodology
- Plan. Establishing the goals and processes necessary to deliver the desired outcomes. Activities include quality planning, defining the approach, resources, and metrics to be used.
- Do. Implementing the plans, policies, processes, and procedures. Activities include service delivery, in addressing and establishing the standards of service.
- Check. Continually audit activities and processes against the requirements. Activities include measurement/analysis, by conducting the audits and collecting the metrics to assess our performance.
- Act. Take corrective action on audit results to continually improve service performance. Activities include assessing the collected data and determining the appropriate actions to sustain or improve our performance. This process is only possible with the proper leadership and oversight that drives our culture, keeps us accountable, and maintains a customer focus.
This PDCA methodology ensures that all deliverables are completed on time, on budget, and meet/exceed Customer expectations.