eSource Data

One of the biggest impediments to the successful adoption of new technology within clinical trials has been the lack of clarity around the regulations as they relate to source data. Within our own daily lives we embrace new technology; the new mobile (cell) phone or stepping onto the next generation of airliner as we fly off on holiday. But when it comes to clinical trials we seem to be stuck in the 1990s, Assero has the experience and knowledge that can ensure you are very much part of the 21st Century.

In addition, Dave Iberson-Hurst is at the forefront of the current thinking around electronic Source Data. He is jointly responsible for the CDISC eSDI document and has been regularly asked to consult with the regulatory authorities on their challenges with the processes and implementation of tools used for such data. He is considered one of the leading experts in the field of eSource data.

Since 2004, Assero has been leading the way with eSource, having been involved in extensive work looking at the regulations as they relate to source data and technology. If you need assistance and advice with the following:

• Understanding regulatory environment
• The eSDI work undertaken by CDISC and its use within the recently released EMA paper
• Approaches with new technology
• Assessment of process and implementations

Assero have the experience you need.