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 handoff triggers realignment. 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, and other documentations. 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 realigning all three, in sequence, before work resumes.
Delay is a scheduling problem and a balance-sheet problem A trial slip 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 automatically propagates 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
One CRF, sent and synced automatically
AI Conductor builds your Case Report Forms and sends them to your EDC, where your sites capture data throughout the trial. As that data comes back, AI Conductor automatically flags any gaps between what the CRF requires and what the EDC captured, so misalignments surface in days, not months.
Gaps go unnoticed Comparing your CRF to what the EDC actually captured is a manual, page-by-page process, so misalignments often surface late, if at all.
AI Conductor catches them first AI Conductor compares your CRF against incoming EDC data automatically, flagging gaps in days instead of months.
From raw data to submission
The trial is over.
The work isn't.
AI Conductor standardizes raw data into SDTM, builds ADaM datasets, generates TLFs, and assembles Clinical Study Reports, exports to submission-ready in hours, not weeks.
What you have is exports Raw sources, no shared structure, no consistent format.
Raw data, mapped and standardized Your data is mapped to SDTM, the industry standard structure for clinical trial data, automatically, and consistently across the trial.
Ready for analysis Analysis datasets are derived from your statistical analysis plan, following ADaM, the industry standard for analysis-ready clinical data.
Your outputs, generated Tables, listings, and figures are generated automatically, no code to write manually, no script to rebuild from scratch for every update.
One report.
Every output accounted for A Clinical Study Report, assembled from all outputs, everything traceable back to the data it came from.
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.