Solutions Built for Life Sciences
Six integrated capability areas — each engineered for the data complexity, regulatory rigor, and operational demands of pharmaceutical, biotech, and clinical research organizations.
AI-Powered Clinical Data Analytics
From raw data to regulatory-grade intelligence.
Bracy Analytics transforms complex clinical datasets — from EDC systems, EHRs, and registries — into structured, analysis-ready intelligence. Our Python and R-based pipelines are engineered for the rigorous data environments of Phase I–IV trials, post-market surveillance, and real-world data programs.
- Automated data cleaning, transformation, and CDISC mapping (SDTM/ADaM)
- Exploratory and confirmatory statistical analysis
- Integrated safety and efficacy reporting
- Scalable cloud-native data pipelines
OncoSentinel™ — Clinical Relapse Risk Stratification
AI-powered cancer relapse prediction. Built for clinical validation and regulatory review.
OncoSentinel™ is Bracy Analytics' flagship predictive ML platform — estimating cancer relapse probability, time-to-relapse, risk category (Low / Moderate / High), and key contributing risk factors for individual patients across cancer types, stages, and treatment histories.
- Relapse probability at 1-year, 3-year, and 5-year intervals
- Time-to-relapse prediction via survival analysis models
- Risk stratification with explainable AI factor attribution (SHAP)
- Multi-algorithm ensemble: Random Forest, XGBoost, DNN, survival models
- Three-tier clinical validation strategy (internal, external, performance)
Clinical Trial Automation
Reduce manual burden. Accelerate time-to-submission.
Automate the data collection, monitoring, and reporting workflows that slow clinical programs. Our automation frameworks integrate with leading EDC, CTMS, and eTMF platforms to eliminate redundant manual processes across the trial lifecycle.
- Automated data review and discrepancy flagging
- Programmatic generation of TLFs (Tables, Listings, Figures)
- Real-time trial monitoring dashboards
- Automated SAE and deviation tracking
Regulatory & Submission Support
AI-assisted submissions built for FDA, EMA, and ICH.
Streamline the preparation, validation, and submission of regulatory packages with AI-assisted document generation and compliance checking. Our tools are designed around FDA, EMA, and ICH guidelines — reducing review cycles and minimizing submission errors.
- Automated NDA/BLA/MAA package preparation
- CDISC compliance validation (SDTM, ADaM, Define-XML)
- AI-assisted clinical study report (CSR) generation
- Regulatory intelligence and gap analysis
Real-World Evidence & Patient Outcomes
Defensible RWE for label expansions and payer submissions.
Harness real-world data from claims, EHRs, patient registries, and wearables to generate evidence that supports label expansions, post-market commitments, and health technology assessments. Rigorous methodology, transparent assumptions, defensible results.
- Comparative effectiveness and outcomes research
- Propensity score matching and causal inference methods
- Patient-reported outcome (PRO) analytics
- HEOR modeling and payer evidence packages
NLP for Clinical Documentation
Structured insight from unstructured clinical text.
Extract structured, analysis-ready data from unstructured clinical notes, adverse event narratives, medical records, and literature using state-of-the-art natural language processing. Purpose-built for the vocabulary and regulatory context of life sciences.
- Named entity recognition for clinical concepts (MedDRA, SNOMED, ICD)
- Adverse event narrative coding and signal detection
- Automated medical record abstraction
- Literature mining and evidence synthesis
A Rigorous Engagement Process
Discovery & Scoping
We assess your data environment, program objectives, and regulatory context to define a precise solution scope.
Solution Design
Our team architects a Python/R-based solution aligned with your infrastructure, compliance requirements, and timelines.
Development & Validation
We build, test, and validate against your specifications — with full documentation for regulatory audit readiness.
Deployment & Support
Solutions are deployed to your environment with training, handover documentation, and ongoing support options.
Five Products Powering These Solutions
View Full Product SuiteDiscuss Your Program Requirements
Our clinical analytics team works directly with your data scientists, statisticians, and regulatory leads to scope the right solution for your program.