Speed Up the Submission Process
Clinical studies generate tremendous amounts of data, and mismanagement of this data can hamper submission assembly and complicate communication between your organization and health authorities. GlobalSubmit offers services to analyze, convert, and standardize clinical and non-clinical data into a format preferred by the FDA. For clinical data, the FDA prefers data submitted in the standard SDTM (Study Data Tabulation Model) developed by CDISC, and in the coming years conforming to this standard is likely to become mandatory.
By converting and validating clinical data according to CDISC standards, you eliminate the inconsistencies associated with manipulating multiple versions of trial data. GlobalSubmit can arrange for development of a data collection system prior to a clinical trial or the preparation of a clinical summary report. Raw legacy data sets from past trials can be processed to conform to current standards. Review and validation of converted legacy data is performed in conjunction with migration.
Taking these measures expedites the electronic submission process, facilitates communication internally and externally, and improves archival efforts.
GlobalSubmit’s resources can complement internal data conversion projects, or take complete ownership of them. Outsourcing helps you assign critical resources to pressing matters, and increases your ability to meet tight deadlines.
CDISC implementation and eSubmission services include:
- Data Analysis
- Legacy Data Conversion
- SAS Programming
- ISS/ISE Support