Phases I-IV Studies

drug_development_CROOur network of clinical experts have extensive knowledge and expertise in early and late phase clinical trials and can provide clinical and strategic product development advice and consultancy regarding study design. We have highly experienced early phase project managers and clinical monitors who can assist Sponsors in site selection, initiation, monitoring and close-out and collection of high quality data and provision of clinical reports.

Smart trial design and methodology in early phases can set the tone for successful late phase studies. CROS NT’s team of clinical data managers and biostatisticians know how to implement the best data management and statistical methodology approaches for successful trial completion.

Phase I
Our expert clinical team has supported hundreds of studies with protocol development, study document development, study monitoring and regulatory consultancy. We have supported several companies in successful Phase I trials with particular expertise in design, methodology and sample size calculation and statistical considerations for Phase I oncology trials which generally involve diagnosed patients.

Phase II
We have particular expertise in Phase II, including helping Sponsors with proof of concept studies. The biometricians play a crucial role in Phase II trials and can potentially implement an adaptive design approach to modify sample size, endpoints or terminate a study doomed to fail.

Phase III
With our full range of clinical, regulatory and biometrics services, our clients gain end-to-end project planning to build quality into their clinical trials from the start – with mitigating risk strategies, efficient and effective time and budget planning, and optimizing the performance of all project management and monitoring activities to meet their critical project milestones into Phase III trials.

CROS NT has a significant amount of experience in Phase III studies where our biostatisticians have implemented successful designs and our Data Managers have successfully managed vast amounts of data for analysis .

Phase IV & Post-Market
We have an international network of clinical experts and partners with the necessary experience to deliver post-market and observational studies across all major therapeutic areas – from small, local based trials to large and complex international trials. CROS NT has extensive experience in managing large Phase IV studies mainly using EDC. We understand what level of data cleaning and analysis is required for this phase.