Clinical Data, Clinical Operations and Statistics are highly dynamic groups in the clinical development arena.

In three parallel themes, Data Management, Clinical Operations and Statistics will be examined through presentation, case studies and discussion focusing on how to achieve operational excellence. During a joint plenary session, topics that bind both groups will be discussed: Risk-based Monitoring, the status of eSource and independent 3rd parties, and Quality Management in Outsourcing.

This year will also be bringing important changes in the European regulatory framework once the ICH E6 Addendum kicks in. Be prepared!

Problem Solving Sessions - Share Solutions and Challenges
The Clinical Forum is piloting a new type of interactive session. We want to offer you the opportunity to bring your challenges/business pains in implementation to the conference and discuss with your peers and assigned experts how to best resolve them:

• More Pharma or Biotech companies are subcontracting full service CROs. What does this third party outsourcing mean for CROs and for oversight by pharma/biotechs and which challenges are you facing? (Will be discussed in Session 1)
• With the adoption of ICH E6 (R2) - the Addendum to CGP - RBQM in Clinical Development is no longer optional. Which challenges are you facing during the implementation of RBQM into the clinical quality management system. (Will be discussed in Session 4)