Technical Resources International, Inc.

IT services tailored for clinical research including systems integration, custom applications, and system validation.

Clinical research support, regulatory affairs, quality assurance, and safety & pharmacovigilance services to bring new drugs to the marketplace.

Comprehensive safety and pharmacovigilance outsourcing services including customized safety monitoring, medical review, signal detection, expedited reporting, and committee coordination.

Comprehensive clinical data management services utilizing Electronic Data Capture (EDC) products and CDISC data standards for database development, data acquisition, and database lock.

Core validation services focusing on 21 CFR Part 11 compliance, accessibility, legal compliance, and search optimization for web-based clinical systems.

Functional outsourcing services offering quality operational, strategic, technical, and regulatory solutions.

Delivering continuous, compliant validation for clinical software.

Clinical Data Management System (CDMS) built on Oracle Clinical and Remote Data Capture platform for collecting, managing, verifying, and reporting electronically captured data.

Support and integration for Oracle AERS and Empirica Trace.

Comprehensive clinical operations services ranging from feasibility and site selection to study start-up, patient recruitment, and real-time clinical monitoring.

Transform your clinical data into one intelligent and integrated ecosystem.

Technology solutions creating user experiences through responsive design, web development, and certified Agile practices ensuring compliance in a regulated industry.

Information and database management services combined with biostatistical analysis for clinical research.

Quality assurance services to ensure compliance and integrity across clinical research operations.

Validation services covering equipment, cleaning processes, systems, and software.

Services assisting in the evaluation and measurement of the impact of drugs or chemical interventions on human emotional, social, and physical states, as well as environmental and ecosystem functioning.

Medical writing and document creation for clinical development phases I through IV.

Medical writing services to develop journal articles, reports, abstracts, and support clinical documentation needs.

Comprehensive auditing services for clinical research sites, pharmacovigilance, vendor qualification, databases, manufacturing, and laboratories.

Expert clinical trial design, biostatistics consulting, and statistical programming services supporting adaptive designs and Bayesian statistics.

Platform expertise on Microsoft SharePoint, Open Text ECM and LiveLink, EMC Documentum, and SpringCM for online archiving and document management.

Custom Business Intelligence solutions utilizing Spotfire or SAS to provide targeted analytics for clinical data.

Business Intelligence (BI) solutions offering secure, self-service access to metric-driven information portals that support clinical operations.

Services providing report generation, database development, data acquisition/extraction/entry & evaluation, and technical writing.

Leverages eSource, ePRO, eCOA, and wearable tech for enhanced data capture in hybrid and decentralized trials (DCTs).

Integration of Oracle's Clinical Development Analytics engine providing immediate access to trial data and metrics through integration with triDMS and TRI Safety solutions.

Comprehensive preparation and management of IND, IDE, NDA, BLA, and PMA applications and associated documentation.

Consulting services ensuring that architecture, code, and clinical systems are properly designed, built, and documented.

Architecture review, installation support, mentoring, code review, tuning, and agile development procedures for clinical applications and data security.

Selects the right sites, drives site activation with speed and precision, and ensures your trial stays compliant and efficient with training and monitoring.

Custom SAS-based Business Intelligence solutions that provide targeted analytics to address specific customer concerns and assist decision makers in clinical programs.

Combines content management, web development, and clinical trials expertise to deliver unified clinical trial information platforms.

Design and implementation of regulatory strategies to optimize your product development pathway, including FDA negotiations and appeals.

Regulatory consulting and dossier development for foreign and domestic registration.

Collection, analysis, and reporting of study metadata to support large clinical research programs and portfolio management decisions.

Delivers intuitive, high-impact data analytics and visualization services that put real-time insights directly into your hands.

Development of quality systems including GCP, GMP, GLP, ISO, and Clinical Quality Management Programs.

Deployment of LIQUENT InSight to support regulatory submissions and IND amendments.

Strategic development of meeting requests, panel meeting packages, and expert coordination for regulatory meetings.

Expertise in analyzing scientific information on environmental and occupational health hazards, managing toxicology databases, and performing risk evaluations.

Post-marketing support including abstracts, manuscripts, and Risk Evaluation and Mitigation Strategies (REMS).

Compliance services focused on 21 CFR and 45 CFR 46, 21 CFR Part 11, ISO certification readiness, FDA inspection readiness, and FDA enforcement action support.

Thoughtful recruitment strategies and participant-first retention plans that drive engagement and reduce dropout rates.

Blending technical precision with real-world clinical insight to deliver timely, tailored solutions.

National and international training and logistics provided to government agencies, associations, and commercial clients, incorporating formats like demonstrations, simulations, scenarios, and case studies.

Customized outreach strategies, communications, and logistics support including market research, advertising, public relations, training, and multimedia design for clinical trials and government programs.

Simplify technology adoption with smart integration, expert training, and real-time support.

Market research services that define target markets, capture data and essential statistics, and design detailed analysis for specified markets throughout outreach campaigns.