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Typically, the cost associated with an EDC build is open ended. The main reason for this is that in order to configure an efficient EDC build, the CRFs and data process need to be defined. Typically, this is not the case. The expectation of sponsors is that the EDC will somehow adjust with the as-yet-undefined process. The EDC is a tool that does exactly what it is told. If it is programmed based on unknown or vague processes, it will yield undesirable results. This prompts reprogramming of the EDC, which adds to the overall cost of implementation. This cycle is what has given EDC implementations such a bad reputation in the industry.
Sponsors wrongly assume that if they use a different EDC for the next study, the problems of the previous study will not be repeated. This is simply not true. The majority of issues are due to the process and CRF design, not the EDC platform itself. This results in cumbersome or delayed implementation of the EDC as well as inaccurate data.
At Innoventz, we believe that the true benefit of EDC is being lost by making it unapproachable in this way. In contrast, we bring a fresh perspective to the industry: (1) We are a seasoned hybrid EDC technical implementation team and CRO data management team. (2) And TrialBLAZER* is our powerful and agile clinical data services package. This combination gives us unique perspective into your study build. We are revolutionizing the industry with this fixed-cost EDC implementation. (We would be glad to provide you with references who can speak to our cross-disciplinary and responsive approach.)
TrialBLAZER is our proprietary methodology for EDC builds designed to capture and develop clinical data completely, efficiently, and effectively. It is built on an industry-relevant Electronic Data Capture (EDC) system and greatly minimizes study set-up time and cost. Our TrialBLAZER facilitates fast and accurate data entry using remote data capture (RDC). RDC enables corresponding real-time validation checks for immediate correction of inaccurate data, and facilitates clinical trial workflow and processes by providing appropriate tools. Using such tools, the Innoventz team can perform data review, analysis, and reporting in real time. We achieve this by cutting down on unnecessary iterations of EDC builds by providing design analysis on CRFs and defining robust data processes that will yield better data.
Call us at (626) 796-3376, email us at info@innoventz.com , or use the Request Information form.