May 8, 2014
Informing the Investigator:
Implementing an Automated SUSAR System
Investigators, health authorities, and ethics committees need to be informed in a timely manner of new and updated SUSARs and SAEs, since these safety reports are an essential requirement for sponsors of clinical trials. Using an automated and secure electronic communication method for this notification has shown to improve patient safety and regulatory compliance, while reducing manual efforts and costs.
In this webinar, the challenge of the prompt reporting of a low or high number of SUSARs to Investigators in global and large-scale clinical trials will be addressed. Additionally, the speaker, Dr. Max Horneck, CEO, maxclinical GmbH, will outline a real-life implementation of a secure communication platform for SUSAR reporting in a mid-size pharmaceutical company.
The following questions and answers will be addressed:
1. What are the expectations prior to implementation?
a. Reduction of work load
b. Return of investment
c. Increase of compliance
d. Improved communication between Sponsor and Investigator
2. What are the challenges during implementation?a. Change management
b. Systems Integration
3. What experiences and lessons are learned after go-live?a. Stakeholder - acceptance
Additionally, attendees may learn how to:1. Plan the migration from paper to an electronic system
2. Roll-out the technology to investigators and study stake-holders
3. Integrate the solution into an eClinical environment
4. Set-up a compliant reporting system
|THIS PROGRAM IS INTENDED FOR|
- SUSAR responsible persons
- Compliance managers
- Heads of clinical operations
- Heads of clinical monitoring or clinical project management
- IT Managers
||Dr. Max Horneck, CEO, maxclinical GmbH
Dr. Horneck graduated at the University in Freiburg with a thesis on cognitive science. He has a background of more than 20 years in information technology for clinical research.
Throughout his career he promoted technology innovation for clinical research: starting using web-based EDC, IVRS and IWRS in the late nineties. In this role he was responsible for the IT service delivery for more than 140 clinical studies in a wide range of indications.
Since 2011 Dr. Horneck focusses on IT supported end-to-end business processes in clinical research for process improvement.
|OUR XTALKS PARTNERS FOR THIS EVENT|
Intralinks 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 the document-centric processes that occur throughout the clinical trial lifecycle. From site recruitment and study start-up to study conduct and close-out, Intralinks provides the business process automation and collaboration platform to help eliminate inefficiency and redundancy, while reducing risk. More than 200 life sciences companies and over 70,000 investigator sites use Intralinks.
maxclinical GmbH is an innovation driver for integrated eClinical solutions. maxclinical provides technology for electronic Trial Master Files (eTMF), Investigator Portals, and systems integration for EDC, IVRS, ePRO and other eClinical systems. We liaise with technology and knowledge partners to provide innovative, effective and compliant solutions for clinical research. Our maxclinical suite integrates eTMF, EDC, IVRS and Investigator Portal into a single environment: a study in the cloud.