Future Best Practice:
Improving Sponsor/Site Collaboration Through eTMF/eISF Integration
Currently, over 80% of site-based documentation is still fully paper based, with both cost and risk consequences for the entire clinical trial process including audit and inspection risk, reduced site productivity, manual reconciliation of TMF and site records, and lack of visibility into site performance. The cost of sending one monitor to a site is typically around $5,000 per day, and fully half the duration of those visits is spent reviewing paper documents. Many sites find monitor visits to be disruptive to the trial process.
Sponsors need to close the loop among CROs, Pharma, Sites and Investigators with an efficient electronic documentation process (such as controlling source documents) that permits seamless communication and efficiently managed workflows rather than organizing paper based study binders. eTMF and eISF solutions support remote monitoring, managing site documentation, maintaining control for the investigator, optimizing monitor site visits, and ensuring long-term document availability for inspection.
The eISF and eTMF solutions integrate easily with your sites’ workflows. Automated distributing and updating ensure that documents are in the right folders, that each party has control over their own data, and that all site documents are up-to-date and inspection ready. Built-in import tools facilitate uploading, and documents are easy to retrieve. Remote monitoring is enabled, with fewer physically signed documents and more electronic approvals.
Join Intralinks’ Andrew Mitchell and Wingspan’s Kathie Clark for this live, online conversation about replacing manual paper-based procedures and implementing secure offsite document access and management.
Learning Objectives for this webinar:
- Understand why past eISF projects have often failed to meet their goals, and what steps can be taken to improve chances of success
- Understand the regulatory requirements about the separation of TMF and ISF, and how an integrated solution can increase efficiency while still allowing each file to be controlled by the responsible party
- Learn how automation can be used to deliver documents from eTMF to eISF, request acknowledgements or signatures only when needed, and request documents from the site if and when needed
- See how sponsors and sites benefit from increased visibility into file completeness and outstanding tasks
Andrew Mitchell, Director, Life Sciences Strategy and Product Marketing, Intralinks
Andrew has many years of experience working in and with the Life Sciences industry, delivering innovative software solutions through his time with Covance, Relsys, Medidata and BioPharm Systems (Oracle Gold implementation partner). With a focus on Software as a Service, he has a strong belief in providing solutions that simplify and improve the user experience and the relevant subject matter expertise to ensure delivery of real benefits and enhanced compliance.
Kathie Clark, Vice President of Product Management, Wingspan Technology
Kathie has over 18 years of experience in content management for Life Sciences. She oversees the development of the Wingspan eTMF, which focuses on bringing transparency, insight and efficiency to all types of eTMF users. She is active in industry groups such as the TMF Reference Model, where she most recently chaired the Metrics and Reports working group. She is also the author of many white papers, blog articles and presentations found on Wingspan’s website and elsewhere.
Who Should Attend?
This program is intended for CEOs/Heads/Directors within Clinical Operations and Information Technology, specifically in the following areas:
- Monitor Organization
- Alliance Management
- Research and Development
- Clinical Research and Development, Clinical Trials, Clinical Monitoring, Clinical Project Management
- Study Start Up and Management
- Site Feasibility and Activation
- Medical Device Development
- Medical Operations and Affairs
- Clinical IT
Intralinks- The secure Intralinks platform 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.
Today over 2,100 clinical studies run on Intralinks, the #1 provider of virtual data rooms for Life Sciences Business Development and Licensing (+$560 billion worth of deals). If you’re interested in joining over 3 million users that have increased productivity, efficiency and security within their organizations, join us at our booth at the exhibition hall.
Wingspan Technology – Wingspan Technology, Inc. provides an industry-leading cloud-based eTMF to both sponsors and CROs. eTMF provides a modern user experience modeled on commercial websites such as Amazon and eBay – dramatically reducing user training time and frustration. Our dashboards and metrics provide unprecedented insight into the status and health of ongoing trials, including the Key Performance Indicators of Completeness, Quality and Timeliness. Simple processes for uploading and checking documents greatly decrease both the time needed for these processes and the possibility of error. Our robust and scalable infrastructure has a proven track record of supporting users in more than 80 countries worldwide in processing up to 15,000 documents a day for hundreds of trials and has been successfully inspected by a number of Health Authorities.