eTMFs and Investigator Portals: Emerging Best Practices in Light of Recent EMA Guidance | April 24, 2014, 2 PM EDT | O’Connor
November 14th, 2013 // 5:46 pm @ jmpickett
The European Medicines Agency this year produced a draft guideline paper titled “Reflections paper on GCP compliance in relation to trial master files (paper and/or electronic) for management, audit and inspection of clinical trials.” The emerging guidance provides unfolding regulator insight into the use of web technology to manage globally distributed clinical sponsor to site information and document exchange. The European health agencies have identified the critical need to facilitate research efficiency by introducing the option to use “portals” as a transfer and exchange mechanism for globally distributed clinical trials.
Several vendors have introduced eTMF solutions to the market. However, these solutions are not architected to deal with highly distributed and uneven work steams between investigator sites and clinical sponsors. The innovoPOINT® clinical and investigator portal was designed to manage the seamless exchange of essential documents from site to sponsor in a GCP compliant virtual private cloud environment. The clinical portal solution was designed to plug in and play with eTMF systems while providing the investigator and CRO-centric flexibility and investigator usability required for success.
What You Will Learn in This GCP Webinar
Daniel O’Connor, President, InnovoCommerce, will present the following information in a webinar Dec. 4. What you will learn:
- A survey of European, US and Japanese regulatory positions around eTMF and clinical portals
- Emerging industry trends-who are the players making up the eTMF/investigator portal market
- Better known methods for planning eTMF and portal exchanges with a focus of quality by design in clinical
- Demonstration of the innovoPOINT solution
- Â Introduction to mobility in eClinical collaboration (iPhone and iPAD app for central site monitoring of essential documents and safety events
 About the Speaker:
Daniel O’Connor brings two decades of technology commercialization experience to InnovoCommerce. Before co-founding InnovoCommerce, Mr. O’Connor was Technology Director for Computer Science Corporation’s (CSC) North American SharePoint practice. Daniel was the co-founder of Zorch Software, which designed and developed SharePoint-based enterprise project management and compliance solutions for the life science industry. Before launching Zorch Software, Daniel was the Vice President of Business Development at Workshare, a leading document collaboration software company. Daniel earned his undergraduate degree from San Francisco State University, and graduate degree from University of California, Los Angeles, as well as a Juris Doctor from University of California, Hastings College of Law.
