Integrated Resource Systems
Integrated Resources, Inc. (IRI) is a nimble and efficient Clinical Research Organization (CRO) committed to providing comprehensive clinical research solutions to Pharmaceutical, Biotechnology, and Medical device companies. They specialize in End to End Clinical Trial Management services for early and late phases of drug development, operating in compliance with regulatory standards and leveraging global networks. Their mission is to serve with integrity as an employer of choice and strategic partner, focusing on quality, customer service, and cost-effective solutions. The company aims to become an industry-leading services organization by maintaining ethical practices, exceeding expectations, and sharing knowledge in clinical drug development.
Industries
Nr. of Employees
small (1-50)
Integrated Resource Systems
Services
Comprehensive management of clinical programs across study start-up, monitoring, medical monitoring, vendor coordination, and study close-out for sponsors in biotech, pharma and medical device sectors.
Data capture, validation, cleaning, CDISC mapping, ePRO setup and database lock activities; available as integrated or stand-alone services and via FSP model.
Supply chain planning, forecasting, inventory management and IRT-enabled patient/randomization workflows with EDC synchronization.
Statistical analysis planning, programming, and reporting services using validated systems and industry practices.
Preparation of protocols, interim and final study reports, clinical study reports and regulatory submissions aligned to ICH and regulatory style guides.
Operational conduct of BA/BE studies including protocol development, subject dosing, clinical sample collection and coordination with GLP bioanalytical labs and statistical reporting.
Comprehensive management of clinical programs across study start-up, monitoring, medical monitoring, vendor coordination, and study close-out for sponsors in biotech, pharma and medical device sectors.
Data capture, validation, cleaning, CDISC mapping, ePRO setup and database lock activities; available as integrated or stand-alone services and via FSP model.
Supply chain planning, forecasting, inventory management and IRT-enabled patient/randomization workflows with EDC synchronization.
Statistical analysis planning, programming, and reporting services using validated systems and industry practices.
Preparation of protocols, interim and final study reports, clinical study reports and regulatory submissions aligned to ICH and regulatory style guides.
Operational conduct of BA/BE studies including protocol development, subject dosing, clinical sample collection and coordination with GLP bioanalytical labs and statistical reporting.
Expertise Areas
- Clinical trial management
- Clinical data management
- Biostatistics and statistical programming
- Pharmacovigilance and clinical safety
Key Technologies
- Web-based eClinical data capture platforms (21 CFR Part 11 compliant)
- Interactive Response Technology (IRT)
- Electronic Patient-Reported Outcomes (ePRO)
- Electronic Data Capture (EDC) integration
News & Updates
Society for Clinical Data Management event held in Chicago, IL from September 10-13, 2013.
Event in Boston, MA on September 25-26, 2013.
Event in Boston, MA on October 1-2, 2013.
Conference in Boston, MA on October 23, 2013.
Coming Soon
Upcoming news articles to be announced.
Society for Clinical Data Management event held in Chicago, IL from September 10-13, 2013.
Event in Boston, MA on September 25-26, 2013.
Event in Boston, MA on October 1-2, 2013.
Conference in Boston, MA on October 23, 2013.
Coming Soon
Upcoming news articles to be announced.