Phase II-IIII Clinical Trials
Quanticate has supported a wide range of global Phase II-III clinical trials in various therapeutic areas. Being a data-focused CRO, rather than a full-service CRO, we have extensive experience working with other CROs, vendors and customer teams. We are able to provide full data-related support, including clinical data management, biostatistics, statistical programming, medical writing and pharmacovigilance. In addition, we have experts that can support the study design in terms of patient numbers and risk-based approaches to monitoring. By optimising study design and having easy access to cross-study data across the development program, Quanticate aims to provide solutions that meet the desired outcomes whilst remaining efficient. Our global capability by utilising teams in the UK, US, India, Poland and South Africa, also enables us to keep costs at an optimal level at both an FTE level and overall relationship level. We have supported these types of trials both at a trial level and part of a larger scale FSP/CSP partnership.
Late Phase Clinical Trials
Many of the trials that we have supported have been phase IV studies or late phase clinical trial programs. These have ranged from small, single country marketing studies through to large global observational trials. In certain circumstances, we have also been able to support clinical monitoring in addition to the data and safety-related aspects of the trials.
We are able to advise on technologies, such as EDC and e-PRO, that can be utilised and offer expertise when developing the trial and defining patient and visit numbers to ensure statistical relevance. Being able to pool these data with those generated in other studies throughout the product development can also help to make better use of the data for decision making processes. Our Centralised Service Provision (CSP) approach, coupled with our IQ portal for data centralisation and visualisation can help this to happen more effectively and efficiently. We understand there are often budget and resource constraints for certain types of late phase studies and our aim is to offer the best solution within the designated budget, whilst maintaining quality and maximising outcomes.
