See what walking in already ready could look like for your study

The challenge. A mid-size sponsor loses weeks translating a finalized protocol into a CDASH-conformant eCRF, an annotated CRF, and an SDTM mapping — tying up scarce data managers before the study can even open.

The approach. Protocol Intelligence digitizes the protocol; CRF Designer generates the eCRF and edit checks; SDTM Annotation produces the annotated CRF and mapping in the same pass — each reviewed and approved by the sponsor's data-management lead.

The challenge. A CRO runs studies for a dozen sponsors, each with slightly different standards. Manual query management and status reporting erode margin and make quality uneven across teams.

The approach. Query Automation drafts context-aware, PHI-safe queries for review; SDTM/ADaM and TLF agents produce submission-ready outputs; the Status Dashboard keeps every sponsor's study health current in real time.

The challenge. An academic medical center runs several concurrent studies with a small team. Consent readability, multi-language versions, and source-document review consume coordinator time, and inspection prep is a recurring fire drill.

The approach. Informed Consent generates plain-language, IRB/EC-ready ICFs; ICF Translation delivers verified multi-language versions; Source Document Review and AE detection surface gaps and safety findings; the eTMF stays inspection-ready continuously.

The challenge. A pre-revenue biotech needs to run its first study credibly but has no in-house data management, biostatistics, or medical writing — and limited runway for vendor spend.

The approach. The platform provides the full stack out of the box: Protocol Intelligence and CRF Designer for build, SDTM/ADaM for datasets, Medical Writing for an ICH E3 CSR draft, and an eTMF on the TMF Reference Model — with qualified reviewers approving every output.