CROS NT is an international Contract Research Organization (CRO) specialized in clinical data services including Biostatistics methodology, programming and analysis, Clinical Data Management, Medical Writing, Pharmacovigilance and Clinical Technologies (EDC, ePRO, IWRS, CTMS) for Phase I-IV drug development trials as well as medical device studies.
We work with Sponsors in a supportive and consultative manner. We offer value by centralizing clinical data and providing a window to show the status of all studies. We maximize re-use from previous studies, standardizing data formats, providing a consistent team – all with the objective of enhancing quality and saving up 40% on cost. We provide the flexibility to work “project by project” or through providing dedicated teams [Functional Service Provision (FSP)].
Programming & Consultancy
Our Statistical Methodology team provides consultancy and training on trial design (including Bayesian and Adaptive Trial Design), sample size calculations, protocol review , DSMB and regulatory meeting support. Our statisticians provide expert analysis services while our Statistical Programmers provide tables, figures and listings along with meta-analyses, data listings, integrated summaries and CDISC mapping
We provide expert clinical data management services for EDC or paper-based trials including database design and programming, eCRF design and review, data entry, review and cleaning, and medical coding. We also support Risk Based Monitoring or Centralized Statistical Monitoring