Transforming a paper-based trial master file to a streamlined electronic document management solution at Sanofi
Supported by:
11 June 2014
4
SHARES
Supported by:
11 June 2014
At Sanofi, managing clinical drug trials was primarily a paper-based process. The logistics of managing this paper-based process for dozens of concurrent trials was daunting, expensive, and time consuming. The company wanted to optimize this manual process with a streamlined digital signature-compliant document management solution operating in a global, web-based collaborative framework. To do this, Sanofi implemented a clinical trial portal, which is based on Microsoft SharePoint portal and collaboration technologies.
What attendees learnt during this webinar:
The business benefits that Sanofi expects to realize from their clinical trial portal
The advantages of the SharePoint platform in implementing the solution
The challenges faced and lessons learned
Keynote speakers
Patricia Brady, Senior International Clinical Trial Manager, Sanofi-Aventis
This report addresses the key factors shaping pharmaceutical formulation, including regulation, QC and analysis.
Access the full report now to discover the techniques, tools and innovations that are transforming pharmaceutical formulation, and learn how to position your organisation for long-term success.
What you’ll discover:
Key trends shaping the pharmaceutical formulation sector
Innovations leading progress in pharmaceutical formulation and how senior professionals can harness their benefits
Considerations and best practices when utilising QbD during formulation of oral solid dosage forms
Patricia Brady is a Senior Business Analyst/Sr. Clinical Trial Manager at Sanofi-Aventis Pharmaceuticals. Mrs. Brady has over 15 years of clinical research experience, spending a large part of her career at Merck. Her career started within Pulmonary Immunology as a Medical Program Coordinator, in which she managed Pivotal Phase II –III trials within Merck’s Pulmonary Immunology Program. Within this project, Mrs. Brady pioneered the use of electronic data capture, over a decade ago. She continued to hold positions of increasing responsibility within the Phase IV post marketing and safety surveillance trials in multiple therapeutic areas such as Analgesia, Asthma/Allergy and Diabetes. She subsequently moved to Sanofi-Aventis where she continued to manage Phase II-III trials in Thrombosis/Cardiovascular therapeutic areas. Mrs. Brady is currently pioneering the use of collaborative technology to facilitate operational excellence in clinical research. These efforts focus specifically on the electronic Trial Master File and Operational Collaboration with external users and Sanofi Alliance Partners.
Guillaume Gerard, Enterprise Program Director, NextDocs Corporation
Guillaume Gerard is the Director of the NextDocs Services organization in Europe. In his role, he is responsible for managing all aspects of NextDocs Professional Services business in Europe.
For the last 7 years, Guillaume has been holding various positions in the NextDocs Sales and Services organizations (Key account manager EMEA, project manager North America), and has been leading strategic quality, clinical and regulatory transformation programs for NextDocs Enterprise customers. Prior to his position at NextDocs, Guillaume has been holding various IT positions with Enterprise customers in Europe.
Supported by NextDocs
NextDocs, a global leader in compliance innovation, enables businesses in regulated industries to achieve compliance with EMA, FDA and other agencies while innovating processes, increasing efficiency and reducing costs. NextDocs provides solutions for managing regulatory documents, SOPs and clinical documents as well as a full set of quality processes from CAPA to complaints. All solutions are 100% browser-based and can be deployed in the cloud or on-premises.
Find out more: www.nextdocs.com
There is no call in number as this webinar will be broadcast through your computer/laptop speakers or headphones. If you visit this page at 15:00 BST on 11 June you will be able to watch and listen to this webinar live.
We’re very pleased that you wish to attend. The webinar is completely free to attend.
The agenda will cover the following:
• The business benefits that Sanofi expects to realize from their clinical trial portal
• The advantages of the SharePoint platform in implementing the solution
• The challenges faced and lessons learned
I am a CRA with a Exactech, Inc. a device company and would like to attend this webinar. Using SharePoint for eTMF purposes is of special interest to me and others at my company. Unfortunately, all those who are interested will be unable to attend. Will this be recorded and available for download after the event?
Yes, the webinar will be recorded so you and your colleagues will be able to watch it ‘on-demand’ and download the presentation slides. The ‘on-demand’ service is available as soon as the live webinar ends. We hope the webinar will prove useful for you and your colleagues.
Regards – Nick
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What is your call in number for this webinar on June 11? Also are providing a WebEx for demo. Thanks.
Hi Abdul,
There is no call in number as this webinar will be broadcast through your computer/laptop speakers or headphones. If you visit this page at 15:00 BST on 11 June you will be able to watch and listen to this webinar live.
Best regards,
Matt
Hello,
I am a TMF manager with Astellas and would like to attend this webinar, could you please let me know the agenda and costs?
Thank you, Alina
Hello Alina,
We’re very pleased that you wish to attend. The webinar is completely free to attend.
The agenda will cover the following:
• The business benefits that Sanofi expects to realize from their clinical trial portal
• The advantages of the SharePoint platform in implementing the solution
• The challenges faced and lessons learned
Regards,
Matt
Hello,
I am a CRA with a Exactech, Inc. a device company and would like to attend this webinar. Using SharePoint for eTMF purposes is of special interest to me and others at my company. Unfortunately, all those who are interested will be unable to attend. Will this be recorded and available for download after the event?
Thanks,
Alex Knisely
Hello Alex,
Yes, the webinar will be recorded so you and your colleagues will be able to watch it ‘on-demand’ and download the presentation slides. The ‘on-demand’ service is available as soon as the live webinar ends. We hope the webinar will prove useful for you and your colleagues.
Regards – Nick