Biostatistics

Clinetra Solutions partners with pharmaceutical and biotech organizations to deliver rigorous biostatistical analysis across all phases of clinical research. With expertise in protocol design, sample size calculations, endpoint strategy, PK/PD modeling, real-world evidence, safety monitoring, and regulatory reporting, Clinetra ensures scientific rigor, compliance, and data integrity. Leveraging innovative Bayesian methodologies and therapeutic expertise across oncology, neurology, immunology, and more, the team works collaboratively with research partners to accelerate drug development, safeguard patient safety, and deliver decision-ready insights that move clinical research forward.

Statistical Programming

Clinetra Solutions delivers reliable and future-ready statistical programming support across all phases of clinical research, ensuring accurate, consistent, and submission-ready outputs. With expertise in CDISC standards, statistical reporting, data validation, legacy data migration, safety and efficacy analysis, submission preparation, and data visualization, the team ensures compliance with FDA, EMA, and global standards. By combining deep therapeutic expertise in oncology, cardiovascular, and infectious diseases with innovative tools and methodologies, Clinetra positions your data for seamless regulatory review, enabling confident decision-making and successful clinical outcomes.

Pharmacovigilance

Protect lives and maintain compliance through proactive drug safety monitoring. Our comprehensive pharmacovigilance solutions keep you strictly aligned with global regulatory expectations from the FDA, EMA, and PMDA, ensuring patient well-being remains at the forefront of your clinical trials and post-marketing portfolios.

Our expert team handles end-to-end Individual Case Safety Report (ICSR) processing, validated signal detection, and rigorous global literature surveillance. We specialize in authoring complex aggregate reports—including PSURs, PBRERs, and DSURs—while developing robust Risk Management Plans (RMPs) across specialized therapeutic areas such as oncology, biologics, and rare diseases.

AutoLit – Automated Literature Intelligence Tool

Streamline biomedical literature searches, screening, and compliance reporting. AutoLit uses advanced AI-driven algorithms and Natural Language Processing (NLP) to continuously monitor global databases like PubMed, Embase, and localized medical journals, filtering relevant data to meet stringent EMA and FDA requirements with unmatched speed and accuracy.

By automating duplicate elimination, tracking adverse event triggers, and generating audit-ready documentation, AutoLit reduces manual screening workloads by up to 70%. The platform features customizable search matrices, automated version control, and multi-user verification workflows to guarantee complete GxP compliance and data integrity throughout your safety screening cycles.

SmartFlow360 – Smarter Document Solutions

Reimagine your corporate document workflows with SmartFlow360, our intelligent solution for enterprise content management, printing cost optimization, and productivity improvement. Designed to eliminate operational bottlenecks, it helps modern businesses operate leaner, smarter, and greener by transitioning manual, paper-heavy tasks into secure digital assets.

The platform delivers powerful capabilities including automated OCR routing, secure cloud archiving, and role-based access controls to enforce strict data privacy standards. With real-time print-fleet usage tracking and advanced business intelligence dashboards, organizations can eliminate waste, reduce overhead costs, and seamless integrate cross-departmental document lifecycles.

Medical Device Vigilance

Ensure the safety and compliance of your medical devices with robust, end-to-end post-market surveillance. Our dedicated vigilance experts monitor device performance in real-world environments, identifying potential risks early and managing global incident reporting to safeguard patient health and maintain market access.

We provide full-lifecycle support under EU-MDR and FDA 21 CFR Part 803 frameworks, managing Medical Device Reports (MDR), Manufacturer Incident Reports (MIR), and comprehensive Trend Analysis. From generating periodic safety update reports (PSUR) to coordinating Field Safety Corrective Actions (FSCA), we bridge the gap between engineering, clinical data, and regulatory authorities.

STEM AI – AI-Powered Visual Question & Answering Tool

Leverage advanced multimodal deep learning to interpret complex scientific diagrams, engineering schematics, mathematical equations, and technical visuals. STEM AI empowers students, academic researchers, and R&D professionals to ask natural-language questions and get instant, highly accurate insights from intricate graphics.

By turning static blueprints, molecular structures, and data charts into interactive learning and analysis tools, STEM AI uncovers hidden variables and provides step-by-step contextual breakdowns. The engine seamlessly integrates with existing learning management systems (LMS) and enterprise research databases to accelerate innovation and deep technical understanding.