Clinical Data Management and Statistical Analysis
Central to the success of any of our projects is robust management of the clinical data. Our group is closely integrated with a dedicated IT group to develop and deliver a globally recognized clinical data management (CDM) system guided by international standards. To secure data consistency, quality, and scientific integrity the CDM group will develop a fully validated database tailored to each study requirements. The customized web-based CDM system allows for a low-costing and securely accessible clinical data capturing and management solution. Our IT group personalizes data capturing to the needs of each site efficiently integrating site data with study database. Collected data is analyzed using SAS software by a statistical team with numerous years of pre-clinical and clinical experience.
To generate the high quality of data expected during any study while being budget-conscientious, our performance-driven CDM solutions and services include:
- Developing validated databases to meet the needs of a study design regardless of complexity
- Specific sponsor data management focus teams
- The ability to provide paper or electronic data capturing at a global level
- The integrated relationship between our CDM and IT group gives us the unique ability to provide our clients with unique data capturing solutions to meet specific study needs.
- Clinical Data Interchange Standards Consortium (CDISC) model for data organization collected in clinical trials and deliverable database
- Data cleaning, validation, query generation and resolution management
- Secure web-based access to study tracker
- Collaborating with client to develop a study guided statistical analysis plan
- Reconciliation of transferred data against the CRF and any serious adverse event
- SAS datasets and use of XPORT to create files in transport format