Clinical Operations bundle · for Head of Clinical Ops
Run the study from one record, not five handoffs
Capture, Control, and Cascade enroll, randomize, supply, and collect data on one governed OMOP record — so clinical operations stop reconciling systems and start running the study.
The problem today
Today the head of clinical ops stitches a CTMS, an IRT vendor, and an EDC together with flat-file exchanges, nightly extracts, and spreadsheets — every handoff a place for data to drift and timelines to slip.
Faster
Stand studies up in days
Config-as-code randomization and supply plans, plus capture that starts mapping at the keystroke, replace the multi-week study-build and database-programming step that gates traditional EDC and IRT setup.
Better
One record, no reconciliation
Enrollment, randomization, dispensation, and clinical data land in the same OMOP store next to the subject's EHR-sourced cohort data — no separate IRT silo and no "who got which arm" spreadsheet to reconcile.
Cheaper
One stack, not three vendors
Capture, Control, and Cascade share one data model, one audit apparatus, and one validation story, so you stop paying for per-vendor licenses, integration projects, and the middleware between CTMS, IRT, and EDC.
How this bundle composes
Run the study with fewer handoffs — enroll, randomize, supply, and collect data once.
Capture turns data collection from transcription into validation — site staff confirm and gap-fill real-world data instead of re-keying charts field by field, so queries are prevented at the keystroke rather than chased after the fact.
Control gives clinical ops a study-operations layer built from the patient's data outward — managing trials and registries on longitudinal real-world data instead of trapping each patient inside one protocol's bounded lifecycle.
Cascade gives clinical ops randomization and trial supply orchestration on the same OMOP substrate as the rest of the study — IRT capability without standing up a separate IRT vendor, silo, or reconciliation process.
Randomize, supply, analyze
Follow one subject from allocation to analysis — Cascade's real randomization engine allocates the subject to a study arm and its dispensed drug, Conduct writes that event's OMOP condition_occurrence via its real FHIR→OMOP mapping, and Calculate reads the same cohort straight back and reports the arm's drug among its analyzed exposures. The OMOP substrate closing the loop from allocation to analysis.
Randomize the subject into a study arm
The SUGAR-01 trial enrolls its cohort. Cascade's real permuted-block engine allocates each subject to a 1:1 arm — metformin or placebo — with balance guaranteed at every block boundary. Subject S-1001's draw is the allocation event.
| Seq | Subject | Arm | Dispenses |
|---|---|---|---|
| 01 | S-1001 | Metformin | Metformin (concept 1503297)← threaded subject |
| 02 | S-1002 | Placebo | Placebo |
| 03 | S-1003 | Metformin | Metformin (concept 1503297) |
| 04 | S-1004 | Placebo | Placebo |
| 05 | S-1005 | Metformin | Metformin (concept 1503297) |
| 06 | S-1006 | Placebo | Placebo |
| 07 | S-1007 | Metformin | Metformin (concept 1503297) |
| 08 | S-1008 | Placebo | Placebo |
| 09 | S-1009 | Placebo | Placebo |
| 10 | S-1010 | Metformin | Metformin (concept 1503297) |
| 11 | S-1011 | Placebo | Placebo |
| 12 | S-1012 | Metformin | Metformin (concept 1503297) |
Cascade's real permutedBlockSequence — the bit-exact R-compatible MT19937 core the product validates for statistical equivalence against randomizeR / carat (ADR-PLT-042) — allocated the enrolled cohort. Balance holds at every block boundary. Subject S-1001 drew the Metformin arm — the allocation event written to OMOP next.
The randomization / dispensation event is written to the platform OMOP store via Conduct's ingest-runner. Conduct maps the subject's study-indication Condition to OMOP next — the honest seam: the vendored Conduct slice is the FHIR Condition mapper, so the event's OMOP write is carried by mapping the indication that keys the analysis; the arm + drug ride alongside as the allocation metadata.
This is the full cross-app journey — open it alongside every CuRE journey.
Why it holds up
- A coordinator enrolls in Control and randomizes in Cascade inside the same Capture workflow — no second login and no flat-file exchange, because eligibility and stratification factors flow straight into the randomization call.
- Every randomization, dispensation, return, and code break writes to the platform OMOP store alongside the subject's clinical record — queryable and audit-defensible by construction, not stranded in an IRT vendor's database.
- Amendments to the randomization plan and supply strategy are declarative config diffs reviewed like code, instead of multi-week vendor change orders.
- Capture, Control, and Cascade carry 21 CFR Part 11 and EMA Annex 11 audit trails on shared infrastructure, so the operational record an inspector asks for is one validation story, not three.
The apps in this bundle
Capture turns data collection from transcription into validation — site staff confirm and gap-fill real-world data instead of re-keying charts field by field, so queries are prevented at the keystroke rather than chased after the fact.
- Prevents work before it becomes work: AI checks reduce queries, SDTM mapping starts at capture, and validation evidence is ready from day one.
- Handles the mid-study amendment: forms are versioned and in-flight subject data migrates across the amendment — the disqualifier most EDCs fail.
Control gives clinical ops a study-operations layer built from the patient's data outward — managing trials and registries on longitudinal real-world data instead of trapping each patient inside one protocol's bounded lifecycle.
- Patient → Data → Studies: registries and trials layer on longitudinal patient data instead of trapping each patient record inside one protocol.
- Anchors the canonical, USDM-shaped study-design model — the Metadata Repository spine that the CRFs, SDTM mapping, and define.xml downstream are generated from, not hand-rebuilt against.
Cascade gives clinical ops randomization and trial supply orchestration on the same OMOP substrate as the rest of the study — IRT capability without standing up a separate IRT vendor, silo, or reconciliation process.
- Algorithm core is built in-house and validated to randomizeR / carat as statistical-equivalence oracles.
- Predictive supply simulation forecasts demand and optimizes overage from the enrollment RWD Cascade owns — RTSM's flagship differentiator.
See the Clinical Operations bundle in action
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