Wednesday 26 March
The ‘next big thing’ for many companies is the leap to full electronic storage of the clinical documentation required to ensure regulatory compliance. During this session, the need, the issues and the benefits will be addressed, including how ‘The Cloud’ can be leveraged as data repository.
11:00 AM-12:30 PM
Increased efficiency in clinical trial execution remains a key target. This session will explore three aspects: faster system set-up, increased compliance of investigators and opportunities for improved monitoring by CRA.
Examples of ePRO, EDC and a clinical portal will be given to describe how to prepare organisations strategically for the implementation of different eClinical solutions.
Find out about approaches that take the next technological steps and how these could completely change the way clinical research is done today.
Databases, Registries and Other Data Capture Tools: How Can We Avoid Multiplicity and Create an Integrated Data-Capture Approach Along the Product Development Cycle?
Various data capture tools are being developed to address different needs at different stages of the product lifecycle. This session will discuss the possibility of creating a wealth of data with these different tools and how these individual systems can be integrated to create a data continuum that supports informed decision-making by all actors and to avoid duplication.
Thursday 27 March
11:00 AM-12:30 PM
Interoperability of ICT-enabled solutions and of data exchange is the precondition for better coordination and integration across the entire chain of healthcare delivery and health data exchange. Equally important are the following four aspects of the interoperability: legal, organisational, semantic and technical.
Find out about the goal of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) to further strengthen the post-authorisation monitoring of medicinal products in Europe by facilitating the conduct of multi-centre, independent, post-authorisation studies focusing on safety and on benefit/risk.
Address some of the ethical and legal repercussions of collecting patients’ data digitally. The potential impact on data privacy will be covered, as well as the likely education that subjects will need to enable them to make informed decisions on the release of their personal data.