Having supported large scale Functional Service Provisions (FSPs) within data related services over many years, such as biostatistics and clinical programming, Quanticate has been implementing an approach that provides the benefits of FSP through niche vendor expertise and flexibility coupled with the advantages of cross-functional support and cross study centralization. The creation of our Centralized Service Provision (CSP) approach to clinical data outsourcing enables activities across functions to be supported in the most efficient way, utilizing experts, global capabilities and a centralized data storage / visualization technology (QuantiCliQ) to enable optimal use of clinical and safety data.
Since the core expertise of a full service CRO is clinical monitoring, site selection, feasibility and site level interactions (a CSP focused around the site, investigators and patients), Quanticate can offer a data-focused CSP solution to enable benefits of combining clinical data management, biotstatistics, clinical programming and elements of medical writing and pharmacovigilance. Our solution involves a combination of on-site and near-site experts coupled with off-shore and near-shore locations to optimize costs. We look at the total cost of the partnership rather than just the outsourced FTE costs, to provide a solution that is cost effective, flexible and easy to work within.
I will say that I have reviewed three Clinical Study Reports (CSR) in the last two weeks [two CSRs were from other vendors] and this draft was by far the best one.
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