CROS NT’s services include regulatory consultancy, monitoring, data management, biostatistics programming & analysis, pharmacovigilance and medical writing – and accompanying eClinical applications (data visualization, EDC, IWRS, eCOA/ePRO etc.). All services are underpinned by strong clinical and biometrics project management.
We offer a center of clinical and data excellence by facilitating data visualization, risk-based monitoring, regulatory submissions, data standardization and traceability to improve efficiency and substantially reduce costs.
CROS NT works with a wide portfolio of Sponsors – from large pharmaceutical companies to small and mid-size pharma, biotech and medical device companies – to define the best outsourcing strategy: whether that be a full service, centralized biometrics approach, Functional Service Provision or case-by-case consultancy.
Expert Clinical, Regulatory and Biometrics Services
From database build to Clinical Study Report, CROS NT is a data-driven CRO with expertise in biostatistics & programming, clinical data management and medical writing. CROS NT has accompanying eClinical technologies (EDC, IWRS, CTMS, eCOA, data visualization tools) to facilitate on-line data collection and reporting
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
Keeping all clinical data with one specialized vendor significantly improves efficiency and quality and results in considerable cost savings of potentially up to 40%
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.