Innovion Website Launch
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| Innovion Website Launch | ||
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It is with pleasure that we announce the launch of our first newsletter and our company website: www.innovion.be. Innovion is a specialized service provider which focuses on helping companies to implement clinical data standards, CRO oversight activities and change management. |
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Conformance Rules to the Study Data Tabulation Model Implementation Guide (SDTMIG) v3.2 have been releasedFor years, the industry has been asking for the ‘official version’ of the SDTM validation rules. Since Pinnacle 21 made it’s Validator Community edition available, it has become the de-facto SDTM validation tool. The tool was originally called the OpenCDISC Validator and is currently still freely available. The check definition within this tool was an interpretation by the P21 developers which often caused confusion, frustration and ‘false positives’.A dedicated CDISC task force with representatives from the FDA, industry and of course P21 have developed an exhaustive and official version of the CDISC SDTM Conformance Rules. These common rules will allow for a transparent single version of the checks to validate the SDTM datasets and define.xml metadata. 
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Good to know…The European Medicines Agency (EMA) has released a “Guideline on GCP compliance in relation to trial master file (paper and/or electronic) for content, management, archiving, audit and inspection of clinical trials” for public consultation? Comments are due on 11 July 2017.This Guideline is expected to provide clarification on the requirements of maintenance and storage of “Essential Documents” such as documentation to demonstrate validation of trial-specific builds of computer systems (e.g. e-CRF and IRT), which are not mentioned in the Essential Documents list of ICH E6 Section 8.
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Meet us at the CDISC European Interchange in LondonCDISC is hosting this year’s CDISC European Interchange in the week of 24-28 April in London with the main 2-day event taking place on Wednesday 26th and Thursday 27th April. This promises to be one of the most exciting events of the year.Peter Van Reusel has been acting as the chair of the European CDISC Coordinating Committee on a voluntary basis over the last 6 years. You will be able to meet Peter at the Interchange as he will be opening and closing the Interchange in the plenary sessions. Jasmine Kestemont will be presenting in Session 5: Standards in Practice between 16:30 and 18:00 on the first day of the Interchange. The title of her presentation is “Clinical Study Oversight: Different Approaches and Starter Pack”. We are looking forward to meet you there!
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CDISC European LiaisonPeter Van Reusel has been contracted by CDISC to act as a European CDISC Liaison. In this important role, Peter will Represent CDISC towards European stakeholders such as the Pharmaceutical Industry, Regulatory Agencies, Academia, Data Standards Organizations and other various stakeholders. He will continue to advocate the value of CDISC standards and advise on CDISC implementation in various frameworks.Peter will combine this new role with his Innovion activities. |
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 CDISC Consultancy | CDISC standards implementationOutsourcing Support | Organizational Support |
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