Safety reporting on SUSARs and SAEs is an essential requirement for sponsors of clinical trials. Investigators, health authorities, and ethics committees need to be informed immediately of new SUSARs, as well as updated information on previously reported SUSARs.

Managing this process is a timely and expensive challenge that binds capacity and bears the risk of non-compliance for the sponsor. Using a secure and automated electronic communication method for this notification can improve patient safety and regulatory compliance, while reducing manual efforts and costs.

In this presentation the challenge of timely reporting of SUSARs to Investigators in global and large-scale clinical trials with a high number of SUSARs will be addressed. The speaker will also outline a real-life implementation of a secure communication platform for SUSAR reporting in a mid-size pharmaceutical company.

The following will be shared:

1. 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. Challenges during implementation

a. Change management
b. Systems Integration

3. Experiences and lessons learned after go-live

a. Stakeholder – acceptance
b. Performance
Attendees will learn how to:
1. Plan the migration from paper to an electronic system
2. Set-up a compliant reporting system
3. Roll-out the technology to investigators and study stake-holders
4. Integrate the solution into an eClinical environment

Keywords:

Speaker

Dr. Max Horneck, CEO, maxclinical GmbH Germany

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.

Message Presenter

Who Should Attend?

SUSAR responsible persons
Compliance managers
Heads of clinical operations
Heads of clinical monitoring or clinical project management
IT Managers

Xtalks Partners

Intralinks

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

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.