Design, Execution And Support
Digital Contract Research Organization

Our focus is the creation and submission of
real‑world evidence packages that will meet
FDA’s stringent requirements.

Able to merge with other national databases using datavant tokenization
Million patient lives
330 Million +
Patient lives
Million patient lives
50 Billion +
Clinical Encounters
Million patient lives
50 Billion +
Pharmacy Claims
Million patient lives
8 Billion +
Laboratory/Diagnostic Encounters

As part of any submission process, the data used for regulatory purposes must be submitted to the FDA. You must ensure that patient-level data is allowed to be transferred. Many US commercial claims databases will not allow for data transfer, even to a regulatory agency. This can be an issue for registries as well, if patients did not specifically consent to third-party data sharing. Given GDPR restrictions, most European datasets with patient-level data are prohibited from transfer.

Because of its partnership with Komodo Health, Slipstream IT is able to transfer your data to the FDA, while maintaining the deidentification needed for HIPPA compliance.