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PhaseV announces
AI Conductor
The AI platform that orchestrates clinical development — from protocol decision to submission-ready package.
The problem
What's driving trial workflow delays.
Delays in clinical development rarely come from one broken step. They come from the seams between them. Every vendor handoff is a re-briefing. Every protocol amendment is a re-sync across teams that don't share a system of record. Stacked across a trial, they add up.
*From the report The State of Clinical Trial Data Handoffs: Spend, Timelines, and Vendor Dynamics.
A third of trials lose a full quarter to reporting alone. From database lock to a submission-ready CSR, one in three sponsors spends nine to twelve weeks turning data into deliverables — SAPs, SDTM, ADaM, TLFs, narratives. That is runway competitors don't have to give up.
Three to five vendors. One trial. No shared source of truth. Protocol, biostatistics, and regulatory work rarely sit with a single partner. Each handoff is a context-transfer, and each protocol amendment means re-briefing all three, in sequence, before work resumes.
Delay is a scheduling problem and a balance-sheet problem. A trial slips can cost a sponsor $600K to $8M in lost opportunity value, accruing daily, independent of why the delay happened.
AI Conductor
PRE-TRIAL WORKFLOW
One conductor,
orchestrating every step
AI Conductor is the single system every workflow runs through, however you start. Medical Writers, Biostatisticians, Regulatory Affairs, and Clinicians all work from the same source of truth. Update a document once, and that change propagates instantly across every dependent file.
Start where you are From a blank slate, early drafts, or past trials, AI Conductor picks up wherever you already are.
Every team, together Medical Writers, Biostatisticians, Regulatory Affairs, and Clinical all work from the same source of truth.
Change once, update everywhereEvery document propagates instantly across the trial. No manual rework. Your team reviews and approves every change.
Optimize at every stepAI Conductor keeps every plan open to optimization, powered by PhaseV's Optimizers, or by the tools your team already uses.
The propagation
Change once.
Propagate everywhere.
A protocol amendment shouldn't trigger weeks of manual updates across dozens of documents. With AI Conductor, every change is made once and propagated everywhere it matters — every SoA, every TLF, every document. Human-validated, always.
Forty-five documents in one dossier. Every one of them carries a piece of the protocol — a window, a threshold, an endpoint definition.
One amendment invalidates all of them. The change is small. The surface it touches is not.
By hand, it moves one family at a time. The SoA has to be settled before the CRFs can start, the CRFs before the SAP. Five weeks later, three documents were never reached — and nothing says so.
Propagated, nothing is left behind. Same order, same dependencies, one pass. Every document reached, traceable to the same amendment, and approved before it ships.
During the trial
Straight from your EDC
Your Case Report Forms populate automatically from your EDC. No manual re-entry, no reconciliation. PhaseV’s ClinOps Optimizer can also keep your sites monitored throughout the trial, so you can adjust course without losing time.
Your data lags behind. Data isn't fed directly into your trial workflow. It's re-keyed by hand, batch by batch, and the gap widens with every cycle.
AI Conductor - One click closes it. Your EDC feeds AI Conductor directly. No manual re-entry, no reconciliation between systems.
From raw data to submission
The trial is over.
The work isn't.
AI Conductor standardizes your raw data into SDTM, builds ADaM datasets, generates TLFs, and assembles your Clinical Study Report — from messy exports to submission-ready in hours, not weeks.
What you have is exports Raw sources, no shared structure, no consistent format
Every variable, mapped Each variable mapped to its SDTM domain, one standardized structure across the trial
Your outputs, generated Tables, listings, and figures produced against the plan, not manually redrawn every time the data changes
One report. Every output accounted for A Clinical Study Report, assembled from all outputs, everything traceable back to the data it came from
Introducing PhaseV AI Conductor
One conductor. Synopsis to CSR. Connected, traceable, human-approved.
Every phase, one system: pre-trial planning, trial data, post-trial reporting, all run through AI Conductor, with your team reviewing and approving every step. That's what turns months of handoffs into hours of work, and it's ready for your next trial.