Transforming a paper-based trial master file to a streamlined electronic document management solution at Sanofi
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
Patricia Brady, Senior International Clinical Trial Manager, Sanofi-Aventis
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