Today’s electronic trial master file solutions (eTMF) only focus on the sponsor TMF and support site interactions through investigator portals. These investigator portals represent a means of communication to receive documents from sites and to publish documents to investigators, which sites can incorporate into their investigator site file (ISF).
Sites, however, are often not moving documents from the portal to the ISF. The portals do not replace the ISF and the regulatory status of documents stored in the portal is unclear. A successful TMF strategy, therefore, needs to include the ISF as a critical component of the full document lifecycle.
This webinar will examine how an eISF can improve site performance and audit readiness, as well as enable a remote monitoring strategy that significantly reduces the amount of on-site monitoring visits.
Kevin McNulty, Product Marketing Director, Intralinks
Kevin McNulty is the Director of Product Marketing for Life Sciences at Intralinks. He is responsible for the go to market strategy for all life sciences solutions at Intralinks. He has over 7 years experience with clinical technology, including EDC, Safety, ePRO, and IVRS. Previous to Intralinks, Kevin worked for Oracle Health Sciences and Phase Forward.
Who Should Attend?
- Site relationship managers
- Compliance managers
- Heads of clinical monitoring or clinical project management
- Heads of clinical operations
- Compliance managers
- Regulatory affairs managers
- IT Managers
Intralinks™ gives Sponsors and CROs a solution for Safety Document Distribution that underpins all communication and processes with a complete audit trail. Intralinks Studyspace™ improves the management of safety documents by providing greater transparency and automated distribution, making it easier to provide the right information to Investigators, Institutional Review Boards (IRBs)/Ethics Committees (ECs), regulatory agencies and patients.
Intralinks in general provides enterprise-class SaaS solutions for secure, compliant and auditable exchange of critical information and workflow management inside and outside the enterprise. Intralinks Studyspace automates and streamlines clinical trial lifecycle processes, site recruitment and study start-up to study conduct and close-out, eliminating inefficiency and redundancy, while reducing risk.