Risk-Based Monitoring has always been in use — the industry just hasn’t had the technology to implement it. Sites are accustomed to dealing with the unique nuances that individual protocols may present, however the recent innovations in EDC and virtual workspaces have allowed these issues to be addressed in real-time and perhaps even anticipated in advance.
The question now remains: Will remote monitoring create an additional and unnecessary burden of responsibility at the site level, or will it make for a more efficient and profitable workflow dynamic?
Andrew Mitchell, Director, Life Sciences Strategy and Product Marketing, Intralinks
Andrew Mitchell has many years of experience working in and with the Life Sciences industry, delivering innovative software solutions. In addition to Intralinks, Andrew’s career includes positions with Covance, Relsys, Medidata and BioPharm Systems (an Oracle Gold implementation partner). With a focus on Software as a Service, Andrew brings his deep subject matter expertise to bear to ensure the delivery of real benefits and enhanced compliance, anchored by a strong belief in providing solutions that simplify and improve the user experience.
Intralinks provides a highly secure platform that helps Pharmaceutical, biotech, medical device companies and clinical research organizations (CROs) to streamline complex and time-sensitive processes such as eISF/eTMF integration, SUSAR report distribution and study start-up with a complete audit trail. Intralinks´ clients automate distribution and collection of sensitive information, centrally organize content while easily managing and monitoring access – making it easier to provide the right information to Investigators, Institutional Review Boards (IRBs)/Ethics Committees ( ECs), regulatory agencies and patients.
Dan Sfera, The Clinical Trials Guru
Dan Sfera has owned and operated clinical research sites since 2005. In 2010 Dan decided to get into blogging about clinical research in order to generate more business for his clinic as well as to attract potential study participants to his existing studies. Soon he discovered that the majority of the audience members were actually other clinical research professionals who were taking to the internet to try and learn more about the industry. His blog became a place to demystify clinical trials and help other research companies accomplish their business objectives by creating practical solutions to their real world problems.
Who Should Attend?
Clinical Trials professionals, including:
- Clinical Site Selection/Management Personnel
- Clinical Site Coordinators (CRCs)
- Clinical Research Associates/Monitors (CRAs)
- Clinical Trial Managers (CTMs)
- Data Managers
- Clinical Operations & Project Management
- Compliance & Regulatory Affairs
Intralinks is changing how we think about secure collaboration by reinventing the way companies do business externally.
Access and share secure documents anytime, anywhere, and from any device. Intralinks gives you the freedom to work beyond boundaries — and the security to do so with absolute confidence.
Discover how we’re helping sponsors and CRO’s revolutionize their clinical trial processes by providing HIPAA-complaint virtual workspaces to investigator sites for them to control and which enable remote monitoring – even of non-redacted patient information.