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Press Release January 19, 2017

Comprehend CRO Oversight Solution Addresses Looming ICH E6 Addendum

Sneak Peek at New CRO Oversight Features plus CEO Case Study Session

Reveal Strong ROI for Clinical Operations Teams

MIAMI, Jan. 19, 2017 — SCOPE 2017 — With the growing need to address the upcoming ICH E6 (R2) addendum, clinical teams face the difficult process of reducing risk while ensuring quality across studies outsourced to Contract Research Organizations (CROs). Comprehend Systems, Inc., a leader in Clinical Intelligence software, today announced new CRO Oversight features that monitor CRO Quality Agreements and Oversight Plans in real-time. The software is specifically designed to facilitate CRO Oversight by improving site performance and data quality while reducing risk in support of guidance under ICH E6.

Clinical Operations leaders will have access to Comprehend’s CRO Oversight and ICH E6 (R2) compliance best practices at the 2017 SCOPE Summit, taking place January 24-26, 2017 in Miami. ClinOps leaders can learn more at the following SCOPE events:

  • Comprehend Exhibit Booth #506 – including demonstrations of CRO Oversight, ClinOps Insights, Centralized Monitoring and Medical Insights applications. Register for a booth meeting in advance and receive a free Amazon Gift Card.
  • Session, Wednesday, January 25, 2017 at 4:30PM ET

    “How a Clinical Trial Team Avoided $420K in CRO Change Orders”, Track: Managing Outsourced Clinical Trials

    Presented by Rick Morrison, CEO, Comprehend Systems
  • Session, Wednesday, January 25, 2017 at 8:55AM ET

    “An Automated Approach to Clinical Quality Management”, Track: Implementing Risk-Based Monitoring, Part 1

    Presented by Kenneth Wu, MS, MBA, of Kenneth Wu and Associates LLC
  • Session, Wednesday, January 25, 2017 at 4:55PM ET

    “Bringing Together Key Stakeholders in RBM”, Track: Implementing Risk-Based Monitoring, Part 2

    Panel discussion led by Kenneth Wu, MS, MBA, of Kenneth Wu and Associates LLC
  • Session, Wednesday, January 25, 2017, 9:20AM ET

    “Challenges in Contracting: A Legal and Biotech Operations Perspective”, Track: Establishing an Outsourced Strategy

    Presented by Bruno Gagnon, President, Xenon Clinical Consulting

In addition, session attendees can receive a copy of Comprehend’s recently released CRO Oversight Benchmark Report. Comprehend surveyed more than 100 leading life sciences leaders to deliver insight into Sponsor goals, challenges and best practices for continuous CRO oversight. The downloadable report covers how program, study and vendor oversight teams are approaching ICH E6 (R2), best practice for Quality Agreements and Oversight Plans, and a roadmap to continuous CRO Oversight.

About Comprehend Systems, Inc.

Comprehend, the leader in Clinical Intelligence solutions, is focused on accelerating treatments to patients. Our suite of software applications provide clinical operations, data management and medical review teams with the critical insights and automation they need to improve the speed, safety and quality of their clinical trials. Designed to unify, monitor and analyze clinical data across disparate sources in real-time, Comprehend’s Cloud software delivers solutions for CRO oversight, centralized monitoring, risk monitoring, data review and medical monitoring. Comprehend’s investors include Sequoia Capital, Lightspeed Venture Partners and Eminence Capital. Learn more at www.saama.com.

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