Across the industry, companies are striving to find ways to improve operational efficiencies. Currently, over 80% of site-based documentation today is still fully paper based, with both cost and risk consequences for the entire clinical trial process. Specific liabilities of a paper-based system include audit and inspection risk, reduced site productivity, manual reconciliation of TMF and site records, as well as the lack of visibility into site performance.
In this talk we will examine how to avoid these inefficiencies in today’s clinical trial process as well as disruptive onsite monitor visits to verify documentation. For large complex phase III studies, monitoring of study sites is typically the single largest study expense, often accounting for 30% of the entire study budget. As you may know the cost of sending one monitor to a site is typically around $5,000 per day, and typically at least half the duration of those visits is spent reviewing documents.
Join Intralinks’ Andrew Mitchell for a live, online discussion about replacing manual paper-based procedures and implementing secure offsite document access and management. You’ll come away with a better understanding of options for managing site documentation, maintaining control for the investigator, optimizing monitor site visits, and ensuring long-term document availability for inspection.
Andrew Mitchell,
Director: Life Sciences Strategy and Product Marketing
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.
- Never reconcile versions of documents in ISF and TMF: Help Sponsors and TMF teams to improve the quality of incoming documentation from the sites.
- Long-Term Archival: Reduce storage costs and effort through a simplified filing system for paper originals (wet ink signatures) and have electronic binders available on-demand.
- Enable CRAs to review documents remotely having access to all study documents without disruptive onsite visits.
- Be ready for inspections, utilize summary and completeness reports as well as directly access previous versions of documents.
- Alliance Management
- Clinical Research & Development
- Clinical Research Associates
- Clinical Operations
- Clinical IT
- Study Manager
- Clinical Monitor
- Clinical Project Management
- Site Feasibility
- Study Start Up
- Site Activation
- Safety Reporting
- Safety Documentation Distribution
- Compliance & Regulation
- Medical Development (for medical devices)
- Medical Operations
- Medical Affairs
