AI
FICS Architect · AI Study Build
An AI study builder, tester, and exporter in one CDISC-native workflow, from protocol to a fully tested study build in hours, not months.
Build
AI study build from the protocol
Hand FICS the protocol document and its AI study parser drafts the complete build, CRFs, visit schedule, and edit checks, as a reviewable draft, every element traceable to the protocol line it came from.
Test
Review and validate before go-live
The build is a draft, never auto-released. Your team reviews and edits it, edit checks are verified against the protocol, and the study is tested before it deploys to EDC, human-in-the-loop at every step.
Export
CDISC-native, in and out
Studies flow in and out through one standard, CDISC ODM-XML, via cdisc-api. Export a FICS study to CDISC ODM-XML, or import a protocol-parsed study, without bespoke integrations.
Inside the product
Build the study, then test it before go-live
What it is
FICS turns the study protocol into a running study and moves its data through one standard. An AI study parser reads the protocol and drafts the complete build, CRFs, visit schedule, and edit checks, for your team to review and test before it goes live. Because FICS is CDISC-native, the same study exports to CDISC ODM-XML, so data flows in and out without bespoke integrations.
Who it's for
Data managers, study builders, and clinical data teams who spend weeks translating a protocol into an EDC build, and sponsors who want to adopt individual AI services, like protocol-document parsing, à la carte even when FICS isn't their CTMS.
Interoperability
CDISC-native, one standard, in and out
CDISC (Clinical Data Interchange Standards Consortium) is the industry-standard format for exchanging clinical trial data (ODM-XML). FICS is CDISC-native, so studies flow in and out through one standard via cdisc-api. The microservice architecture lets sponsors adopt AI services, like AI-enabled protocol-document parsing, à la carte, even when they don't use FICS as their CTMS.
Import, protocol document → FICS study
Export, FICS study → CDISC ODM-XML
Capabilities
From protocol to clean, portable data
Protocol-to-study build
Generate CRFs, the visit schedule, and edit checks directly from the protocol document.
Source-grounded and traceable
Every generated element cites the protocol line it came from.
Human-in-the-loop
Output is a draft for human review and approval, never auto-released.
Intelligent edit checks
Generate and maintain edit checks grounded in the protocol.
CDISC-native interchange
ODM-XML in and out through cdisc-api, the industry standard for exchanging clinical trial data.
À la carte via microservices
Adopt AI services like protocol-document parsing on their own, even without using FICS as your CTMS.
Pairs with FICS EDC for capture and FICS Sentinel for continuous data-integrity monitoring.
Build it, test it, and take your data anywhere
See how FICS turns a protocol into a running study, and exports clean data through CDISC.