In developmentAsk more
of your data.
Direct agents to investigate collected data, answer research questions and generate SDTM / ADaM datasets. Use natural language or the UI, with the protocol, shared study model and statistical analysis plan (SAP) guiding the work.
Explore clinstead resolve with us“The interim cut is approaching. Reconcile EDC, lab and dosing data. Tell me what threatens the analysis—and prepare the work to resolve it.”
Protocol & study model / EDC, lab & dosing data / SAP
Use the study schedule, cohort rules and analysis requirements to establish what should exist for this cut.
Three signals. Three different next moves.
- Transfer gap
- The lab has the scheduled result. Reconcile the transfer before asking the site to recollect.
- Unit conflict
- The result and reference interval use different units. Hold the interpretation for a reviewed conversion.
- Timing conflict
- A post-dose sample precedes the recorded dose. Prepare an evidence-linked query; preserve both source records.
Follow the reasoning
The same missing-value report can hide very different causes. Study expectations, source records and timing relationships let the agent propose the right action for each finding. An uncertain match stays unresolved.
From a wall of discrepancies to work that matters.
The same Clinstead study model. Design intent, source evidence and reviewed decisions travel into the data work.
A question becomes
a course of action.
“Why is this endpoint incomplete?” An answer may require the collection schedule, EDC records, a lab transfer and the SAP. clinstead resolve is being built to bring them into the same investigation, work through the dependencies and deliver an evidence-backed next step.
Ask for a dataset instead, and the work changes: map the sources, apply the agreed definitions, derive the variables and check the result. SDTM, ADaM and their metadata become outputs of that work.
The study remembers
why.
clinstead designer connects what you intend to collect with the forms, visits, rules and decisions that define the study. clinstead resolve will bring that same context to the data you receive—then extend it with mappings, derivations and analysis decisions.
Already collecting elsewhere? Start there. The planned workflow brings your protocol, collection definitions and incoming data into the model. Your existing EDC remains part of the picture.
See how the study stays connectedKeep the work.
Move the answer forward.
A reviewed transformation should become reusable work. When new data arrives, agents will identify what changed, rerun affected work within its approved scope and explain the difference in the results.
A new assumption, a changed SAP definition or an unresolved source conflict returns to your team. The plan, inputs, methods and review decisions stay connected to each output.
Go deeper: follow a value from source to analysis
Inspect a mapping, change an analysis measure and follow a derivation. This interactive illustration uses synthetic study data.
Prepare temperature at Week 4 for analysis.
Prepare Week 4 temperature change from baseline.
Two ways to specify the same analysis. Select an example to explore it.
Week 4
ADVS excerpt
PARAMCD TEMP AVAL 36.8 BASE 37.1 CHG -0.3
Lineage
TEMP-002· collected valueVS.VSSTRESN· sequence 2ADVS.AVAL· 36.8TEMP-001+ SAP §7.2 →BASE→CHG
Excerpt only; not a complete conformant dataset or submission.
Interactive concept · synthetic records · not a live generation service
Selected instruction: Prepare Week 4 temperature change from baseline.clinstead resolve is in development. The examples show the workflows we are building, including SDTM, ADaM and Define-XML output.
Bring the question. Keep the evidence.
See your workflow with ClinsteadStart with the work you have. Show us where you want to go.