Arena International’s flagship event, Outsourcing in Clinical Trials New England, is almost upon us. This year’s edition, taking place on September 6-7, 2017, at The Westin Waterfront, Boston, will gather an unprecedented number of industry experts set on equipping you with the tools necessary to optimize your clinical outsourcing strategies and in-house processes.
Now that ICH’s E6 revisions make it official; a risk-based approach to clinical trial quality – commonly referred to as Risk-Based Monitoring or RBM – is now a codified GCP expectation of for the industry, you can expect to see a host of sessions exploring the new ICH E6 R2 guidelines, which have been introduced to encourage the adoption of more efficient approaches for clinical trial design, conduct, oversight, recording and reporting while continuing to ensure human subject protection and reliable trial results. While it may sound complex, it’s important for organizations to know that Risk-Based Monitoring strategies can be relatively straightforward to implement, providing that they work collaboratively with the correct study partners to identify and employ the right tools that will help manage the change in the most-effective way to reap the benefits quicker. You can learn more about the ICH E6 updates in context of RBM from our CRO partner, PSI CRO’s, OCT New England session: Utilizing ICH E6 Rev 2 Defined Risk-Based Approach to Monitoring in Clinical Trials – The CRO Perspective, where Kirill Soldatov, Director Process Improvement, will explore Risk-Based Monitoring concepts, requirements and benefits.
You can find CluePoints at booth 21, where we’ll be showcasing our innovative Risk-Based Monitoring and Data Quality Oversight software, which is designed to enable organizations accomplish a risk-based approach to trial monitoring in line with guidance, such as the ICH E6 R2. If you can’t wait to learn more about the ICH E6 Revisions, download our latest whitepaper: Summary of Themes Whitepaper on Company Response to the ICH E6 Revisions to learn how organizations’ like yours, are aligning with the ICH E6 updates.
We hope to see you there!
