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Especially for developing or working with SEND submission data, there is a high need to be able to switch from Pinnacle21 for validation of SEND data to CDISC CORE. The reason is the pricing strategy of Pinnacle21 with prices that are unaffordable by companies active in the non-clinical space. CORE is however completely free of charge and even open source.
Furthermore, due to priorities at CDISC, not all SEND rules have gone into the v.1.0 release of CORE. Some are still in development, other are still "awaiting QC".
Jozef Aerts of XML4Pharma has developed most of the SEND rules for CORE as a CDISC volunteer. He is therefore also the perfect person to help these companies with the implementation in their systems and processes, and to help them with the development of "custom quality rules", i.e. rules that are "on top" of the CDISC rules, and guarantee quality of SEND submissions. These "custom" rules can be specific for the company, sponsor-specific or study-based. Such developed "custom" rules can then easily be added to the existing CORE engine, i.e. one can see them as an extension to the CDISC engine and the existing SEND rules.
If you need more information about our services for CORE and especially for implementation of SEND in core, just send us an e-mail at info@XML4Pharma.com
More general information on our CORE consultancy services is also available here.
We find knowledge and technology transfer important. We are not one of these consultants or technology providers that provide you with a black-box solution.
At the contrary, during an assignment, we learn your people understanding the CDISC standards and how to work with them.
When developing a software solution specific for your company, we provide the source code of that software together with the full software documentation.
