Solutions · Pharmaceutical Sponsors
More studies, the same team, and every timeline you commit to is one you're quietly worried about. Neogeniqs puts an agentic workforce across the whole lifecycle — protocol to submission — so your studies start sooner, stay clean, and stay inspection-ready without the headcount you can't hire.
What you own
We know how this feels
You're asked to run more trials, faster, with a team that isn't getting bigger — and the TMF and the submission package are the two places you know it will show.
And the part no one says out loud:
Where the agents fit
The grind you just read isn't abstract — each piece of it already has an agent assigned. Here's which one picks up which fight, so you can see exactly where the help lands before you commit to anything.
The pain
Your whole study waits on one manual read
The agent on it
Protocol Intelligence AgentDigitizes any protocol and extracts its structure — objectives, eligibility, and the schedule of assessments.
The pain
Study build shouldn't swallow your timeline
The agent on it
CRF Designer AgentTurns a protocol into CDASH-compliant eCRFs with edit checks and validation rules.
The pain
Every data cut shouldn't restart your mapping
The agent on it
SDTM/ADaM Dataset AgentTransforms raw and collected clinical data into submission-ready SDTM and ADaM datasets across all standard domains with controlled terminology applied.
The pain
The 100th TLF shouldn't be programmed by hand
The agent on it
TLF Generation AgentProduces submission-quality tables, listings, and figures from ADaM datasets using a library of 100+ CDISC- and FDA-standard output templates.
The pain
Your CSR shouldn't be 3 to 6 months of transcribing figures
The agent on it
Clinical Study Report (CSR) AgentAssembles ICH E3-structured Clinical Study Reports that pull results directly from your TLFs and datasets, with full track-changes review support.
The pain
Your TMF shouldn't scare you before an inspection
The agent on it
eTMF Workflow AgentA BPMN-driven workflow engine that routes, approves, and lifecycles Trial Master File documents against the TMF Reference Model v3.3.1.
Your agentic workforce
These feature agents map most directly to pharmaceutical sponsors. Enable the ones you need, per study and per deliverable, and expand over time.
Digitizes any protocol and extracts its structure — objectives, eligibility, and the schedule of assessments.
Learn moreTurns a protocol into CDASH-compliant eCRFs with edit checks and validation rules.
Learn moreTransforms raw and collected clinical data into submission-ready SDTM and ADaM datasets across all standard domains with controlled terminology applied.
Learn moreProduces submission-quality tables, listings, and figures from ADaM datasets using a library of 100+ CDISC- and FDA-standard output templates.
Learn moreAssembles ICH E3-structured Clinical Study Reports that pull results directly from your TLFs and datasets, with full track-changes review support.
Learn moreA BPMN-driven workflow engine that routes, approves, and lifecycles Trial Master File documents against the TMF Reference Model v3.3.1.
Learn moreOutcomes
Quantified targets we build toward with each engagement.
Every output is grounded, reviewed, and inspection-ready
“The part that sold us wasn't speed — it was walking into conduct without dreading the TMF. The gaps surface while we can still fix them, instead of six weeks before an inspection.”
Illustrative — representative of the workflows we build toward during our pre-launch pilot.
No pressure, straight answers
The doubts that usually surface before a team like yours says yes — answered plainly, including the places where the honest answer is a limit rather than a promise.
See it run on one of your own studies — no pressure, no obligation, and honest answers, including on the limits. We will walk pharmaceutical sponsors through exactly what stays under your control.
