Clinical Trials - statsby.ai

Accelerating Clinical Trials with AI-Powered Data & Insights

Home > Solutions > Clinical Trials

Statsby Solutions helps CROs transform complex clinical trial processes into faster, smarter, and more compliant operations.

Our AI-driven data solutions are built to support every stage of the clinical trial lifecycle—from protocol design and patient recruitment to data management, safety, and regulatory reporting. By reducing manual effort and strengthening data integrity, we help CROs deliver reliable results with speed and confidence.

Get A Free Consultation

Our Solutions

Intelligent Trial Design & Feasibility

Protocol-to-Feasibility Agent

Identify recruitment challenges before they happen. Our AI analyzes protocol requirements against real-world patient data, helping you predict feasibility and avoid costly amendments.

Site Selection & Ranking Agent 

Pinpoint the best-performing sites using data on patient demographics, investigator experience, and historical trial outcomes—accelerating site activation and boosting enrollment success.

AI-Enabled Protocol Optimization 

Run simulations and refine inclusion/exclusion criteria with generative AI. Improve feasibility, reduce amendments, and design protocols that deliver better results.

Smarter Patient Recruitment & Retention

Automated Eligibility Screening 

AI interprets complex protocol criteria and screens patients against electronic health records—reducing site burden and expediting enrolment.

Duplicate Subject Detection 

Protect trial integrity with AI-powered checks for duplicate or fraudulent patient enrollment, ensuring safety and compliance.

Predictive Recruitment Analytics 

Forecast patient availability and engage participants through multi-channel outreach—improving recruitment precision and long-term retention.

Data Management & Quality Assurance

AI-Driven SDV & SDR Automation 

Cut manual verification efforts in half. AI compares source data with EDC entries, freeing monitors to focus on meaningful data discrepancies.

Seamless Data Reconciliation

Continuously identify and resolve mismatches across clinical systems, helping you achieve faster database lock with higher accuracy.

Lab Data Harmonisation 

Standardize lab test results from multiple vendors with normalized ranges, ensuring consistent safety and eligibility assessments.

Regulatory Compliance & Reporting

Consistent Medical Coding 

Improve coding accuracy for adverse events and medications with AI-driven recommendations aligned to MedDRA and WHODrug standards.

Automated CSR Drafting

Speed up study report creation with AI-generated narratives linked to protocol and statistical outputs—cutting prep time by up to 40%.

Traceability & Audit Readiness 

Maintain complete traceability with embedded audit logs and hyperlinks, ensuring inspection readiness at all times.

Pharmacovigilance & Safety Intelligence

Early Signal Detection & Case Processing 

Use AI to detect emerging safety issues and streamline case reporting with automated coding and narrative generation.

Predictive Risk Analytics 

Leverage real-time modeling to forecast safety risks, enabling proactive mitigation before issues escalate.

Knowledge Graphs for Safety Insights 

Transform unstructured text into connected biomedical knowledge graphs that uncover hidden patterns and accelerate discovery.

Specialized Supporting Services

Biomarker & Lab Data Automation

Automate the ingestion, cleaning, and harmonization of biomarker and lab data for reliable downstream analysis.

Integrated eCRF & EDC Platforms

Adopt modern, AI-enhanced EDC platforms that streamline data capture and improve quality.

Lab Normal Range Harmonizer 

Apply advanced statistical standardization to ensure consistent lab safety signals and eligibility evaluations across diverse trial sites.