Webinar: Enhancing Clinical Operations with Digital Signatures
Sponsored by: CoSign Digital Signatures by ARX
Focused on:
Date: 17th November
Days old: 4829
Time: London 3PM / New York 10AM
How paperless authorizations can result in faster site and study initiation and more!
Now more than ever before, life sciences companies are turning to eClinical technologies to automate their processes. This is because they understand—perhaps better than anyone—what inefficiency means to their business: among other disadvantages, it means hindered collaboration, increased costs, and project delays. By automating processes and reducing the use of paper, life sciences companies can achieve the results they need to keep their business moving forward.
With standard digital signatures, life sciences companies are able to maintain compliance with the strictest industry regulations while achieving trusted electronic document exchange that spans geographies and organizations. Digitally signed documents enable any party to quickly and easily validate signer identity and intent, and content integrity without reliance on proprietary verification technology. As such, they enable organizations to automate approval processes and enjoy streamlined operations, enhanced efficiency, reduced organizational costs, and more.
In this session, attendees will learn how digital signatures can be applied in clinical operations to speed study and site initiation, automate site monitoring reporting, enhance investigator portals, and support regulatory compliance. We will also discuss how digital signatures enable secure document exchange and electronic submissions. Case studies of leading sponsors and CROs will be presented and a Q&A session will be held at the end of the presentation.
Presented by
Rodd Schlerf,
FDA and USDA Markets Manager - ARX
With over 20 years of experience in electronic signatures for FDA-regulated markets, Rodd Schlerf has led ARX to be the largest supplier of digital signatures in the FDA regulated industry. As a result, clinical operations organizations around the world are benefiting from reduced costs, faster operations, regulatory compliance, secure document exchange and electronic submission to the FDA.
Paul Fenton,
President and CEO – Montrium Inc
Paul Fenton holds a degree in management from London Metropolitan University as well as an MBA in Technology Management from the Université du Québec à Montréal.
Paul has over a decade of senior level experience in the life sciences industry with an emphasis on the development, deployment and management of computerized systems for use in regulated clinical trials. He co-founded Montrium in 2005 and has worked on major clinical technology projects both in Europe and North America. Paul has a strong background in CDISC and ICH standards as well as in the integration of systems and processes for clinical trials.
Paul is currently working with multiple pharmaceutical companies both in Canada and in the United States on the implementation and integration of computerized systems and processes such as EDC, CTMS, EDMS and electronic submissions in line with regulatory requirements and industry standards. He is a regular speaker at industry events and is actively involved in several projects for the development of clinical research standards and platforms.
Contact Paul Fenton at [email protected]
Key Learning Objectives
- Learn how clinical site initiation can be expedited with digital signatures
- Learn how to cut costs and ensure timely reporting by CRAs with digital signatures
- Learn how digital signatures ensure document security and compliance, and efficiently support audits
- Learn how digital signatures bridge trust to enable secure document exchange and electronic submissions
Audience
- CIO/CTO/CISO/CSO
- COO
- Clinical Operations
- COO
- QA / QC / Validation
- CCO
- Other Compliance / Risk / Regulatory Position
- Pharmacovigilence / Safety
- QA / QC / Validation
- Regulatory Affairs