An AI-powered text mining solution automating biostatistics, data operations, and medical writing — delivering regulatory-ready outputs in minutes.
Repurposing Clinical Information
What TrialAccel® Does
TrialAccel® is a protocol-driven clinical development acceleration solution that digitizes the clinical protocol using AI-powered technology and transforms its content into high-value draft outputs across Biostatistics, Data Operations, and Medical Writing. Auto-generates Statistical Analysis Plan, table shells, statistical reporting specs, and analysis datasets from protocol text.
By digitizing protocol information and repurposing it intelligently, TrialAccel® enables study teams to reduce manual effort, improve consistency, and accelerate critical study collateral — with qualified human oversight where it matters most. Produces SDTM/ADaM specs, annotated CRFs, edit checks, and data management plans in an expedited manner.
How Can It Benefit You?
Effective use of AI-powered solutions for full digitization of clinical trials workflow
Significant savings in biostatistics, data operations, and medical writing functions
Improved speed and accuracy with fully automated data operations workflow
Outputs comply with ICH guidance, GAMP5 validation, and full GxP requirements
All TrialAccel® operations execute on sponsor environment — ensuring complete on-premise data and intellectual property security with zero external exposure
Six Integrated Components — One Seamless Workflow
Auto-generates SAPs, table shells, statistical reporting specifications, and analysis dataset structures directly from protocol text. Pre-configured frameworks with regulatory-aligned outputs ready to edit.
Produces SDTM/ADaM specs, annotated CRFs, edit checks, and data management plan in an expedited manner.
Creates draft Clinical Study Reports and disclosure reports through automated narrative generation. Protocol-driven narrative reduces first-draft timelines by up to 60%.
Native export of structured study definitions. Supports standardized regulatory submissions and enables interoperability across systems. Accelerates CDISC USDM adoption readiness.
Cross-field validation checks and protocol-to-output alignment assurance. Built-in rules check completeness, consistency, and regulatory alignment before delivering draft outputs.
Full audit trail of all actions with role-based access control. Meets GAMP5 validation and GxP standards. Designed for 21 CFR Part 11 readiness with full version control and change documentation.
Competitive Landscape
See how TrialAccel® stacks up against generic AI tools, manual processes, and legacy CTMS solutions across every critical capability.
| Capability | TrialAccel® | Generic AI | Manual Process | Legacy CTMS |
|---|---|---|---|---|
| Protocol Extraction | 50 fields | Unstructured | Manual | None |
| FDA-Grade Confidence | 95% | No scoring | Variable | N/A |
| SAP/DMP Generation | Automated | Generic | Manual | None |
| USDM v3.0 Support | Native | None | None | None |
| On-Premise / Data Privacy | 100% | Cloud only | Yes | Varies |
| Audit Trail / 21 CFR 11 | Built-in | None | Paper | Partial |
| Fine-tuned for Protocols | 1107 examples | Generic | N/A | None |
Key Benefits
TrialAccel® delivers measurable improvements across quality, speed, compliance, and scale.
Dramatically lower biostatistics, data operations, and medical writing costs by automating manual, repetitive document creation workflows.
Accelerate study readiness with AI-generated draft outputs delivered in days instead of weeks, compressing overall timelines.
Eliminate transcription errors and inconsistencies. AI-driven cross-referencing ensures alignment between protocol, analysis plan, and reports.
Support multiple concurrent studies without proportional headcount increases. Scale from single-study to full portfolio management.
Why Small Biotech Chooses TrialAccel®
Maintain ownership of data operations and regulatory submission processes without full CRO dependency. Provide CROs with sponsor-approved specifications, making collaboration more efficient and auditable.
Adopt AI/ML within validated analytical pipelines with full transparency and traceability.
Achieve consistent biostatistics and statistical reporting delivery across studies and timelines.
Submit with confidence knowing all outputs align with current ICH guidance and regulatory expectations.
Grow from single-study operations to multi-program portfolios without proportional cost increases.
Smarter CRO Collaboration
Provide CROs with pre-built, sponsor-approved SAPs, dataset specs, and reporting templates, eliminating back-and-forth negotiation cycles.
Every deliverable includes full version history, change tracking, and audit trails for transparent, inspection-ready CRO collaboration.
Transform CRO relationships from delegated execution to strategically aligned partnerships with shared quality standards.
Quantified Impact
Turn Protocol Intelligence into Actionable Study Outputs. Join leading biotech teams leveraging TrialAccel® to accelerate study timelines, reduce costs, and future-proof clinical workflows — all with enterprise-grade security.
ROI quantified across functions
SAP & table shell automation
Specs, CSRs & disclosures
Data & IP Protection
Every TrialAccel® operation executes locally on your IT infrastructure. Zero data leaves your environment. Your IP stays yours — always.
The product is installed on local IT server of the sponsor. No data shared outside the IT server of sponsor!
No data is shared with AI/ML applications. The product works locally on the IT server of the sponsor. All outputs comply with ICH E6(R2), ICH E9, and FDA/EMA submission standards.
All intellectual property of the sponsor remains with the sponsor. TrialAccel® meets GAMP5 validation requirements and GxP standards with full audit trails, version control, and change documentation.
Get Started
Join leading biotech teams leveraging TrialAccel® to accelerate study timelines, reduce costs, and future-proof clinical workflows — all with enterprise-grade security.
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