Traditional methods of running clinical trials, with reliance on manual processes and data silos, are increasingly being dispensed with. The adoption of clinical metadata repositories brings clear long-term benefits, as well as short-term ROI. However, it’s vital for organizations to be armed with the right strategy, from vendor selection through to implementation.

Register for this webinar to hear a data expert from the Dutch biotech, argenx, as they reveal their recipe for success, and the pitfalls to avoid throughout the journey. Gain insights into their end-to-end strategy, from vendor selection to go-live, and learn how they ultimately leveraged clinical metadata repository technology to achieve efficiencies and drive data standardization.

Thought leaders from argenx and Formedix will draw on their implementation as a real-world case study, and help attendees develop a benchmark for clinical metadata repositories roll out.

Participants will also have the opportunity to see the clinical metadata repository abilities discussed by argenx demonstrated live by Formedix.

Specifically, participants will learn:

The benefits of adopting a clinical metadata repository
Strategies for a successful clinical metadata repository implementation, from vendor selection to go-live
Common pitfalls and how to avoid them
How partnerships can facilitate adoption of data standards

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Speakers

Jasmine Kestemont, Data Management Consultant, argenx

Jasmine Kestemont works for argenx as a Consultant in Data Management. She is a results-oriented people leader, with a systematic approach to problem solving. Jasmine is passionate about the value of data. She loves a complex challenge and aims to deliver pragmatic, innovative and cost-effective solutions. Jasmine has proven that efficiencies can be gained through data standardization and strongly believes that success is built on partnerships.

Message Presenter

Steven Benham, Professional Services Manager, Formedix

Steven Benham has been with Formedix for over 4 years. Starting originally as a Solutions Consultant, he worked to author and present Formedix training courses for SEND, SDTM, Define-XML, ODM-XML, Define-XML and Dataset-XML. He has also been involved in a number of clinical data programming projects helping to deliver in Interim Analysis (IA) SDTM and FDA SDTM clinical submissions. He is now the Professional Services Manager and currently oversees all Formedix clients.

Message Presenter

Gilbert Hunter, Customer Success Manager, Formedix

Gilbert joined Formedix over seven years ago as a Technical Writer. Four years ago, the knowledge gained from content development, together with his customer service skills, marked him out for transition to the Professional Services Team.

In his current role, Gilbert provides CDISC and software training, support and consultancy services to pharmaceutical, biotechnology and CRO organisations. He helps them save time and money by making their clinical trial design and regulatory submissions more efficient.

Message Presenter

Who Should Attend?

This webinar will benefit those responsible for, or involved in, the selection of a clinical metadata repository. It will also benefit those looking to introduce standardization into their clinical trial design and build process. This includes people working on data standards, data management, regulatory compliance (including CDISC) and governance in pharmas, biotechs, CROs, universities and medical device organizations, including:

Regulatory Affairs
Clinical Operations
Clinical Affairs
Project Management
VP/Director of Data Standards or Data Management
Executive/Associate Director of Data Standards or Data Management
Head of Data Standards or Data Management
Data or Data Standards Manager/Associate Manager
Clinical Data Associate
Team Leader of Data Standards or Data Management
Data Manager/Clinical Data Manager
Data Standards or Data Management Specialist

What You Will Learn

Real-world benefits of adopting a clinical metadata repository
Strategies for a successful clinical metadata repository implementation
How to avoid the pitfalls around vendor selection and implementation
How partnerships can facilitate adoption of data standards

Xtalks Partner

Formedix

Want to get your clinical trials designed, built & submitted faster? Now you can, with the Formedix off-the-shelf clinical metadata repository (MDR) and metadata automation platform. We’ve taken away those time-consuming and expensive manual tasks – from study set up to submission.

Our clinical MDR provides a central home for your organizational standards. Here you can manage, update, approve and reuse organizational standards, whilst keeping aligned with the relevant version of CDISC standards. You can even share and reuse content across different EDC and e-clinical systems from the Formedix platform.

And if you need help automating study design and build, Formedix can help with that too. Their clinical trial automation tools use the content in your MDR to build studies much faster. Whether you want to design eCRFs, build EDCs, design or convert datasets, or make define files…Formedix helps you do it in a fraction of the time.