IRT’s Role in Clinical Trial Continuity

Andrew Rohrbaugh, Vice President, Strategic Solutions As the Coronavirus (COVID-19) pandemic continues to impact clinical trials globally, we have seen a significant shift in focus to trial continuity – identifying ways to ensure that existing study participants are able to continue receiving investigational product, and maintain their participation in an ongoing clinical trial. Distribution vendors…

Strengthening eClinical Data Integrity Series – Part 3: Enhanced Compliance Strategies

Terek Peterson, MBA, Vice President Customer Experience and Data Science As the use of eCOA expands to incorporate more submission-critical elements, especially key endpoints and factors contributing to per protocol analyses, customized compliance strategies are more important than ever to ensure data integrity. By following ALCOA principles for data integrity, quality assurance processes, system controls…

CBI’s Annual IRT Conference Highlights – 2019

Bryan Clayton, Vice President, Strategic Solutions Last week was my seventh consecutive year of attending CBI’s IRT conference. It’s great to reconnect with colleagues and see familiar faces at each event. While accustomed to hearing common themes each year, which have recently focused on data standards, inspection readiness, new technology and protocol complexity, I’m always…

The Value of Data Standards in Clinical Trials: The Time is Now

Terek Peterson, Vice President, Clinical Analytics and Data Strategies What’s the Issue? Adoption of data standards are necessary to underpin higher data quality, efficiencies and integrated applications across increasingly complex clinical research processes. Global regulatory agencies have clearly embraced data standards for the submission of data, laying the groundwork for expanded adoption, to data collection,…