Region:  
 
      Advanced
Search 		 
Bookmark and Share 
  
Find An Educational Offering
Select Search Criteria
Keyword:
Events starting on or after:  mm/dd/yyyy
Events Added:
Region:
Interest Areas (IA): Hold the CTRL key to select or de-select multiple items from adjacent list box

     
Event Type: Hold the CTRL key to select or de-select multiple items from adjacent list box

 
 
© 2010 DIA  |  Home  |  Site Map  |  Contact Us  |  Terms and Conditions of Use  |  Disclaimer  |  Privacy Policy
  Click here to Expand the Tab 
10244 WEBINAR: The Emergence of Digital Signatures in Clinical Operations
 Overview 
 Registration Fees 
 Continuing Education 
 Related Offerings 
 Technical Requirement 
 Speakers 
Title:
WEBINAR: The Emergence of Digital Signatures in Clinical Operations

Date(s) And Time(s):
Oct 5 2010 11:00AM - Oct 5 2010 12:30PM

Interest Area(s):
Clinical Research,Regulatory Affairs,Quality Assurance/Quality Control

Overview:

The past five years have shown a dramatic growth of digital signature use in clinical applications. Regulatory compliance, expedited processes, and significant cost savings are among the many benefits that have enabled clinical organizations to gain a competitive advantage by taking their approval processes electronic.

Digital signatures enable clinical organizations to:
• Create, control, and share documentation internally and externally in a trusted, compliant, and secure manner
• Adhere to 21 CFR part 11, GxP audits, HIPAA, SOX, and other regulations and effectively support regulatory audits
• Eliminate the hard costs of paper-based approval processes, i.e., printing, routing, archiving, etc.
• Expedite processes and enhance collaboration including secure document exchange and electronic submissions

This webinar will address business benefits, technical challenges, and deployment considerations from CRO, sponsor, and SaaS/CSO perspectives based on real-world use of digital signatures in the clinical market today.

Featured Topics
• Case studies of actual digital signature deployments within:
   - Quality, audit, and compliance operations
   - Site monitoring and field operations
   - Investigator Portals
• Case studies presented on live installations at large Pharma, Medical Device, and Software-as-a-Service (SaaS) based clinical services.
• Applications discussed range from quality and compliance documentation, investigator site monitor reporting, clinical trial management (CTMS) and Investigator Portal for Trial Master File forms.



Learning Objectives:
At the conclusion of this webinar, participants should be able to:
• Describe the business benefi ts and deployment considerations for digital signatures within clinical operations
• Identify the ROI (return on investment) that digital signatures bring to clinical organizations
• Explain the importance of selecting digital signature technology that complements existing infrastructure (low total cost of ownership), integrates with common business applications and end user requirements (to facilitate user adoption)

Target Audience:
Professionals involved in IT, clinical informatics, clinical
operations, QA and RA at:
• CROs
• Study sponsors
• Clinical technology vendors
• Site monitoring and fi eld operations
• Investigator portals
• Medical device companies
Functional responsibilities: clinical research associates, project
managers, clinical operations, quality assurance, regulatory
affairs, training, IT, information security, document management,
records management, validation and compliance.

Event Code:
10244

Contact Information:
Questions about this Webinar? Contact Wendy Moyer at the DIA offi ce in Horsham, PA by telephone +1.215.293.5810, fax +1.215.442.6199, or email Wendy.Moyer@diahome.org.