Founded in 1992, CROS NT is a global Contract Research Organization (CRO).
With a strong heritage in clinical data management and statistics, we offer a center of excellence for clinical trial data with a full service capability.
Our data-driven approach facilitates excellent quality control, risk-based monitoring, adaptive design, data standardization, data integration, traceability, data visualization, vendor oversight and data analytics. This results in us achieving high quality, maximum efficiency and reduced costs for our customers.
Services include clinical data management, biostatistics programming and analysis, pharmaco- /device-vigilance, regulatory consultancy, monitoring, and medical writing – all underpinned by strong project management. These services are supported by industry-leading and proprietary technologies including data visualization, clinical analytics, EDC, eCOA, IVR, mHealth, data anonymization and data integrity analytics.
CROS NT works with pharmaceutical, biotech and medical device companies to help them determine the best outsourcing strategy whether that be centralized biometrics, functional service provision (FSP), ad hoc support, or a full service approach.
Keeping all clinical data with one specialized vendor significantly improves efficiency and quality and results in considerable cost savings of potentially up to 40%
Commitment to Quality & Data Standards
Since we work with sensitive patient and trial data, CROS NT is ISO 9001:2015 certified for our Quality Management System and ISO 27001:2014 certified (Information Security Management System) for our IT systems and processes. CROS NT is also a CDISC Gold Member and part of the E3C European CDISC Coordinating Committee.
CROS NT offers a clinical trial solution to deliver Sponsors the biometrics oversight needed to assess data integrity from multiple sites with a ICH GCP E6(R2) compliant workflow.
Functional Service Provision
Have a need for a temporary or longer-term resourcing solution? CROS NT has perfected the FSP model to cater to any size company with our 5-point model. We offer FSP to large and small companies to meet the operational, economic and logistical needs of Sponsors
Data De-Identification & Anonymization
CROS NT offers support for data anonymization compliance starting with patient-level data with a comprehensive process and expert team of statisticians, programmers, medical writers and regulatory professionals. We can offer up to Level 3 data privacy protection which includes the risk of data linking.
Integrated Summaries of Safety & Efficacy
The ISS and ISE are required documents for regulatory submission. Having prepared numerous Integrated Summaries for EMA and FDA submission, we provide expert project management, statistical programming & analysis and medical writing services to ensure successful, efficient and cost-effective ISS/ISE preparation.