The operating system for clinical trials.
TrialSync coordinates literature synthesis, protocol design, statistical analysis, and regulatory submission inside a single tamper-evident workspace — where context never dies between teams.
Context dies between teams.
Literature findings live in PDFs. Protocols live in Word. Analysis plans live in SAS. By the time a safety signal reaches Regulatory, the chain of reasoning is already gone — and the trial is already off-course.
When Evidence, Design, and Regulatory share the same coordination layer, a conflict that would normally surface in week 14 surfaces in week 2.
Four specialists. One shared memory.
Each agent is purpose-built for one stage of protocol development — and every output is permanently linked back to the evidence that justified it.
Literature Scout
Synthesizes global research. Surfaces safety signals, contraindications, and patient sub-populations.
Protocol Design
Drafts inclusion / exclusion criteria, endpoints, and visit schedules — every clause linked to evidence.
Statistical Analyst
Builds the analysis plan, sample-size calc, and code specs. Escalates ambiguous endpoints in-band.
Regulatory Agent
Drafts IND submissions. Cross-references every claim against the upstream chain. Flags inconsistencies.
A coordination layer, not another inbox.
Agents don't email each other. They announce, escalate, and resolve inside a single shared workspace. Every decision is observable. Every output is anchored to the upstream context that produced it.
- Evidence findings remain attached to design decisions, forever.
- Conflicts surface in-band — no offline coordination loss.
- Every agent action carries a cryptographic provenance chain.
- Human reviewers join the same thread, not a parallel one.
Signal detected · Renal impairment (eGFR <30) shows 3.1× safety event rate. Source: NEJM 2023-A.
Acknowledged [H2-A]. Updating exclusion criterion 1.4 → eGFR ≥30 required.
Sample size recalculated · n=412 → n=387 to preserve 0.8 power at adjusted criterion.
Conflict resolved · IND Section 4.2 now consistent with Evidence Brief #08. Audit hash locked.
Audit-ready from day one.
TrialSync is built to 21 CFR Part 11 standards. Every agent decision, every edit, every coordination signal is sealed in a tamper-evident chain — inspection-ready without a single export.
- Immutable agent outputs with electronic signatures
- Version-locked records, cryptographic hash per artifact
- Reason-for-change captured automatically per edit
- Inspection-mode export for FDA / EMA / PMDA reviewers
Accelerate your path to first-in-human.
Get immediate access to TrialSync and launch your secure workspace dashboard to manage active trials.