2nd Innovion Newsletter

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2nd Innovion Newsletter: SEPTEMBER 2017

In this newsletter:

-PhUSE Annual Conference, Edinburgh
-Launch Oversight Service
-CDISC User Group Meeting
-Launch EudraCT Service
-CDISC International Interchange, Austin

We sincerely hope that you enjoy this newsletter.  Please forward this to your colleagues or friends that may be interested!
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PhUSE Edinburgh

The annual PhUSE event is coming closer and we are excited to meet many of you in person during one of the most important industry events.

Jasmine Kestemont will be presenting “Clinical Study Oversight: Different Approaches to Using Data Standards” in the Data Standards and Governance session on Monday at 16:30. This talk will focus on how difference levels of standardization enhance quality control and oversight. 

Jasmine is also co-chairing the management stream and will moderate the management workshop “Innovation – Applying the Google Sprint Techniques to Approach Problems”, presented by Tom Grey, Head of Cloud Solution Architecture, EMEA at Google

Innovion, CDISC and Transcelerate Biopharma are pleased to organize the CDISC Hands-on Workshop “Moving from 2D to 3D standards” on Tuesday at 13:30.  Every year, we strive to bring hot topics and new, interactive content to this workshop:
  • CDISC What’s New?
  • Implementing LOINC
  • Share 2.0 Business Value
  • RDF Demo & Metadata Concept Exercise
Peter has a long history of organizing the CDISC workshop at the PhUSE events and he is particularly excited that CDISC and Transcelerate are supporting this workshop directly.

There is still time to register: http://www.phuse.eu/cdisc-how-2017
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Launching Oversight Service

Innovion is very proud to formally launch our Oversight Service. This new offering combines the years of experience that Innovion has built in biometrics processes, managing CRO deliverables and implementing Data Standards.

Many clinical trial sponsors, large and small are outsourcing clinical trials.  Managing the quality of the deliverables is often seen as a hurdle to true success.

This service focuses on small to medium pharmaceutical companies, biotech & medical device companies and other clinical trial sponsors that have a need to take their organization to the next level.

Through an exploratory workshop, Innovion will provide a phased approach that will increase the control, quality and submission-readiness of the clinical study deliverables.
  • Optimal data collection, standardization and future use of your data
  • Ensuring regulatory compliance of clinical submission deliverables
  • Fit for purpose, data oriented strategy
  • Communicating with Biometric CROs
  • Provide the right specifications to ensure a smooth study set-up
  • Verifying and validating the CRO’s deliverables
  • Selecting and implementing a robust infrastructure
If you are interested to learn more, we would appreciate the opportunity to present our Oversight Service to your company.

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CDISC French Speaking User Group meeting

The CDISC GUF (Group Utilisateurs francophones) is organizing their 2nd Annual meeting on Wednesday, September 27th at the Pullman Brussels Midi in Belgium. Innovion will be presenting “Clinical study oversight: different approaches and starter pack” at 11:45 and we are looking forward to an exciting day of discussions and social networking. We look forward to meeting you there.

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eudract serviceEudract Service

We are happy to announce the launch of our EudraCT Trial Summary Posting Services.

Since 21 July 2014, it is mandatory for sponsors to post clinical trial results in the European Clinical Trials Database (EudraCT), managed by the European Medicines Agency (EMA). 

Innovion offers a fast and flexible solution to ensure compliance within the defined timelines.  Over the past years, an expert team has developed a standardized and partly automated routine to deliver this high-quality service.

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cdiscCDISC International Interchange, Austin, Texas

In good yearly tradition, Innovion will attend the CDISC International Interchange in Austin in the week of November 13th, one of the most informative and exciting events of the year. We are again looking forward to meeting many friends and welcome new people to data standards.

On Monday and Tuesday before the Interchange, Peter Van Reusel will co-train the new “Standards from the Start workshop”. CDISC Standards from the Start is designed for an academic research audience; it is also useful for anyone working in regulated or non-regulated research who desires a non-technical introduction to the CDISC standards,

On Wednesday November 15th, CDISC is organizing a special 3rd Track which focuses on welcoming CDISC newcomers. Peter Van Reusel will chair Session 4 of Track C: “CDISC Standards Beginning-to-End”.

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-CDISC Consultancy | CDISC standards implementation
-Outsourcing Support | Organizational Support
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