Competitors are promising faster timelines. Protocol amendments cost a median of $141K–$535K each and take months to implement. Documentation errors delay submissions by 3–6 months. Your documentation pipeline is the lever that changes all of it.
RegulatoryFlow Report Creator delivers near-zero-error CSRs, Preclinical Reports, and Labs Reports — now extending from clinical into nonclinical workflows. Deployed in weeks, priced per study, with unlimited users.
For your writers and scientists: it works inside Word. You stay in the loop — reviewing, editing, approving. Less copy-paste, more narratives.
No new systems to learn. RegulatoryFlow works as a Word add-in. If your team uses Word, they can use Report Creator in under two hours of training.
Import TFLs directly into Word with automated formatting, standardization, and analytics-ready tables. Near-zero transfer errors on every run.
Integrated in Report CreatorGenerate CSR sections with validated quality, customized to your style guide and report structure. Handles complex adaptive Phase I designs. Your writers review, edit, and approve every section — human in the loop by design.
Available NowPreclinical Final Report sections and Labs Reports rolling out through Q2–Q3 2026 with the same near-zero-error standard and validated quality.
Preclinical Launch PricingYour team has likely tried ChatGPT or similar tools and found them unreliable for regulatory work. Here's why — and how Text Engineering is fundamentally different.
Text Engineering uses deterministic rules — not probabilistic language models — to transform structured clinical data into regulatory documents. The output is consistent, auditable, and near-zero-error every time.
Hallucinations. Inconsistent output. No audit trail. Not compliant.
Deterministic. Auditable. Near-zero errors. Designed for 21 CFR Part 11.
What began as a clinical reporting collaboration has expanded into a broader framework for accelerating the entire early-phase journey — from nonclinical safety through clinical proof-of-concept. The collaboration has achieved first-draft clinical study reports and successfully demonstrated high-quality parsing of raw and SEND datasets for nonclinical workflows, a first-of-its-kind AI bridge between development phases.
Accurate, publication-ready text generation — without human typos or AI hallucinations. Automated TFL processing that eliminates manual errors. Your experts as humans in the loop every step of the way, satisfying regulators and audit requirements.
Our cloud-based sandbox lets you evaluate Report Creator on synthetic TFLs before involving IT or sharing any confidential data.
Submit a request. We verify your identity via email or a brief call.
Explore Report Creator with pre-loaded synthetic TFLs. No confidential data. No IT approval.
Ready for more? Provide sample TFLs under our confidentiality terms and see results on your data.
Roll out the Word add-in. Two-hour training. Unlimited users. Dedicated success manager.
Evaluate Report Creator without any procurement overhead. The sandbox uses synthetic clinical data — no confidential information required, no IT integration needed.
No per-seat licensing. No annual platform fees. You pay per study, and your entire team gets full access.
Clinical CSRs · Preclinical Final Reports
Preclinical Final Reports · Labs Reports
Volume pricing available. Annual study bundles lower your per-study cost. Contact us to discuss the right tier for your organization's study volume.
Your writers and scientists didn't train for years to spend their days on copy-paste and boilerplate drafting. Report Creator generates accurate text and handles TFL processing — here's what changes.
Early partner feedback indicates medical writers reclaim roughly half or more of their time. Report Creator handles both the mechanical work — TFL transfers, formatting, cross-referencing — and generates first-to-second-draft-quality text for report sections, freeing writers to focus on clinical interpretation, narratives, and the judgment calls that require their expertise.
In testing, a significant proportion of manually transferred tables were found to contain errors that trigger rework cycles. Text Engineering's deterministic approach virtually eliminates these, reducing downstream regulatory queries and amendment risk.
Every section generated by Report Creator is reviewed and approved by your medical writers before finalization — with integrated editing, version tracking, and section-level sign-off. This isn't a limitation; it's a feature that regulators expect and your team will appreciate.
For leadership: First-to-second-draft text generation and automated TFL processing mean faster turnaround, winning more bids, and serving more sponsors. Fewer errors mean fewer regulatory queries and amendments — less risk per study. Per-study pricing scales with your workload, not your headcount.
For your writers and scientists: No more manually drafting boilerplate sections from scratch. No more copying output tables into Word and verifying every cell. Report Creator generates accurate draft text and formatted tables — you refine, interpret, and approve. Focus on the analysis and clinical judgment that make your work meaningful.
| Capability | Traditional Enterprise | RegulatoryFlow | Generic AI Tools |
|---|---|---|---|
| Pricing | $500K–2M annual license | Per-study only | Monthly subscriptions |
| User Licenses | Per-seat fees | Unlimited users included | Per-seat pricing |
| Implementation | 6–12 months | 4–8 weeks typical | Variable |
| Training | Weeks of training | 2 hours (Word-based) | Moderate |
| Accuracy | Manual QC required | Near-zero errors (deterministic) | Hallucinations / inconsistent |
| Regulatory Compliance | Yes | Designed for 21 CFR Part 11 | No |
| Infrastructure | On-premise / complex cloud | Secure AWS cloud | Various |
| Sandbox / Free Trial | Rarely | Free sandbox, synthetic data | Usually |
Beyond software — hands-on consulting to transform how data flows through your entire organization.
We take only 5 consulting clients per quarter to ensure each engagement gets the depth it deserves. Our founder and technical teams work directly with your leadership to redesign how data moves between medical writing, data management, regulatory, and labs teams.
Every organization moves at its own pace. Here's what a typical engagement looks like at the 50th percentile, accounting for real-world scheduling, legal review, and IT processes.
No infrastructure changes needed — just a Word add-in. Secure AWS cloud backend means no on-premise installation, which dramatically simplifies IT review. The main variable is your organization's internal legal and security timelines, which we accommodate with parallel sandbox access.
RegulatoryFlow is the product of Evidence Matters' quarter-century track record in clinical trial data, training, and technology.
Our patent-pending Text Engineering technology doesn't just automate — it understands the intricate relationships between clinical data and regulatory requirements. This near-deterministic approach means consistent, accurate outputs every time, processed in a highly secure AWS cloud environment. Your data never trains our models without explicit permission.
TFL Module
Report Creator
(Clinical CSR sections +
Preclinical Report sections)
Remaining sections:
CSRs, Preclinical,
+ Labs Reports
Protocol
Creator
Full Regulatory Suite
+ Submission Package
Each module works standalone or integrated. Start anywhere, scale as you need. Unlimited users always included.
Yes. The cloud sandbox is free and uses synthetic TFLs — no IT approval needed, no confidential data required. You can evaluate Report Creator yourself before any purchasing conversation.
Generative AI guesses — and hallucinates. Text Engineering is deterministic: it transforms structured data using rules, not probabilities. The result is near-zero errors, full auditability, and architecture designed for 21 CFR Part 11. No hallucinations, no inconsistent outputs. And every section is reviewed by your medical writers — the human in the loop is built into the workflow.
Report Creator runs inside Microsoft Word — the tool your writers already use every day. Training takes two hours. It generates accurate first-to-second-draft text for report sections and handles TFL formatting automatically, removing the most tedious parts of the job. Writers refine, interpret, and approve — they remain the human in the loop, with every section reviewed, edited, and signed off by your team before finalization. This is their tool to be more productive, not a replacement for their judgment.
Architecture designed for 21 CFR Part 11, SOC 2 aligned security framework, HIPAA aligned, GDPR ready. All data is encrypted at rest and in transit. Processing happens in secure AWS cloud infrastructure with data residency controls. Your data never trains our models without explicit written permission. NDA executed early in the implementation process. Data Processing Agreements (DPAs) are available for organizations that require them.
Yes. We provide a security overview during the discovery phase, and detailed documentation — including vendor qualification packages, SOC 2 details, and data handling policies — is available under NDA. Most IT security teams find the review straightforward given our minimal footprint: a Word add-in connecting to a secure AWS backend.
Yes. Report Creator is proven on complex adaptive Phase I study designs and is adaptable for later-phase studies. The platform handles the additional complexity of adaptive protocols — variable dosing cohorts, interim analyses, and dynamic table structures — with the same near-zero-error standard.
Customization to your internal style guide, report structure, section headings, and SOPs is included at no additional cost. Every organization formats regulatory documents differently — we configure Report Creator to produce output that matches your standards, not a generic template.
Report Creator works inside Word and exports to any system that accepts Word documents. No replacement of existing tools, no disruption — just enhancement. API integrations for direct CTMS/eTMF connectivity are on the roadmap.
Absolutely. Start with one therapeutic area, one team, or one study type. Unlimited users are included regardless of scope. Most organizations expand after seeing results on their first studies.
Report Creator currently covers the majority of sections across Clinical CSRs, Preclinical Final Reports, and Labs Reports with validated quality and meaningful time savings. Remaining sections for all three report types are completing through Q2–Q3 2026. The roadmap section above has the full schedule.
Join Altasciences in pioneering the next era of regulatory documentation. Start with the sandbox — no cost, no commitment, no IT approval.